Amblyopia
Conditions
Keywords
Amblyopia
Brief summary
To compare the efficacy of 1 hour/day of binocular game play 5 days per week plus spectacle correction with spectacle correction only, for treatment of amblyopia in children 4 to \<13 years of age.
Detailed description
The purpose of the study is to compare the efficacy of 1 hour/day of binocular game play 5 days per week plus spectacle correction with spectacle correction only, for treatment of amblyopia in children 4 to \<13 years of age.
Interventions
OTHERiPad®
Binocular therapy using a Dig Rush application on an iPad®
OTHERSpectacle correction
Spectacle correction for all waking hours, 7 days per week
Sponsors
Jaeb Center for Health Research
Pediatric Eye Disease Investigator Group
National Eye Institute (NEI)
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
SINGLE (Outcomes Assessor)
Eligibility
Sex/Gender
ALL
Age
4 Years to 12 Years
Healthy volunteers
No
Inclusion criteria
1. Age 4 to \<13 years 2. Amblyopia associated with strabismus, anisometropia, or both (previously treated or untreated) 1. Criteria for strabismic amblyopia: At least one of the following must be met: * Presence of a heterotropia on examination at distance or near fixation (with or without optical correction, must be no more than 5pd by SPCT at near fixation (see #6 below) * Documented history of strabismus which is no longer present (which in the judgment of the investigator could have caused amblyopia) 2. Criteria for anisometropia: At least one of the following criteria must be met: * ≥1.00 D difference between eyes in spherical equivalent * ≥1.50 D difference in astigmatism between corresponding meridians in the two eyes 3. Criteria for combined-mechanism amblyopia: Both of the following criteria must be met: * Criteria for strabismus are met (see above) * ≥1.00 D difference between eyes in spherical equivalent OR ≥1.50 D difference in astigmatism between corresponding meridians in the two eyes 3. No amblyopia treatment other than optical correction in the past 2 weeks (patching, atropine, Bangerter, vision therapy, binocular treatment) 4. Requirements for required refractive error correction (based on a cycloplegic refraction completed within the last 7 months): * Hypermetropia of 2.50 D or more by spherical equivalent (SE) * Myopia of amblyopic eye of 0.50D or more SE * Astigmatism of 1.00D or more * Anisometropia of more than 0.50D SE NOTE: Subjects with cycloplegic refractive errors that do not fall within the requirements above for spectacle correction may be given spectacles at investigator discretion but must follow the study-specified prescribing guidelines, as detailed below. 1. Spectacle prescribing instructions referenced to the cycloplegic refraction completed within the last 7 months: * SE must be within 0.50D of fully correcting the anisometropia. * SE must not be under corrected by more than 1.50D SE, and reduction in plus sphere must be symmetric in the two eyes. * Cylinder power in both eyes must be within 0.50D of fully correcting the astigmatism. * Axis must be within +/- 10 degrees if cylinder power is ≤1.00D, and within +/- 5 degrees if cylinder power is \>1.00D. * Myopia must not be undercorrected by more than 0.25D or over corrected by more than 0.50D SE, and any change must be symmetrical in the two eyes. 2. Spectacle correction meeting the above criteria must be worn: * For at least 16 weeks OR until VA stability is documented (defined as \<0.1 logMAR change by the same testing method measured on 2 consecutive exams at least 8 weeks apart). * For determining VA stability (non-improvement): * The first of two measurements may be made 1) in current spectacles, or 2) in trial frames with or without cycloplegia or 3) without correction (if new correction is prescribed), * The second measurement must be made without cycloplegia in the correct spectacles that have been worn for at least 8 weeks. * Note: since this determination is a pre-study procedure, the method of measuring VA is not mandated. 5. VA, measured in each eye without cycloplegia in current spectacle correction (if applicable) within 7 days prior to randomization using the ATS-HOTV VA protocol for children \< 7 years and the E-ETDRS VA protocol for children ≥ 7 years on a study-approved device displaying single surrounded optotypes, as follows: 1. VA in the amblyopic eye 20/40 to 20/200 inclusive (ATS-HOTV) or 33 to 72 letters (E-ETDRS) 2. VA in the fellow eye 20/25 or better (ATS-HOTV) or ≥ 78 letters (E-ETDRS) 3. Interocular difference ≥ 3 logMAR lines (ATS-HOTV) or ≥ 15 letters (E-ETDRS) 6. Heterotropia with a near deviation of ≤ 5∆ (measured by SPCT) in habitual correction (Angles of ocular deviation \>5∆ are not allowed because large magnitudes of the deviation would compromise successful playing of the game.) 7. Subject is able to play the Dig Rush game (at least level 3) on the study iPad under binocular conditions (with red-green glasses). Subject must be able to see both the red "diggers" and blue "gold carts" when contrast for the non-amblyopic eye is at 20%. 8. Investigator is willing to prescribe computer game play, or continued spectacle wear per protocol. 9. Parent understands the protocol and is willing to accept randomization. 10. Parent has phone (or access to phone) and is willing to be contacted by Jaeb Center staff or other study staff. 11. Relocation outside of area of an active PEDIG site for this study within the next 8 weeks is not anticipated.
Exclusion criteria
1. Prism in the spectacle correction at time of enrollment (eligible only if prism is discontinued 2 weeks prior to enrollment). 2. Myopia greater than -6.00D spherical equivalent in either eye. 3. Previous intraocular or refractive surgery. 4. Any treatment for amblyopia (patching, atropine, Bangerter filter, vision therapy or previous binocular treatment) during the past 2 weeks. Previous amblyopia therapy is allowed regardless of type, but must be discontinued at least 2 weeks prior to enrollment. 5. Ocular co-morbidity that may reduce VA determined by an ocular examination performed within the past 7 months (Note: nystagmus per se does not exclude the subject if the above VA criteria are met). 6. No Down syndrome or cerebral palsy 7. No severe developmental delay that would interfere with treatment or evaluation (in the opinion of the investigator). Subjects with mild speech delay or reading and/or learning disabilities are not excluded. 8. Subject has demonstrated previous low compliance with binocular treatment and/or spectacle treatment (as assessed informally by the investigator)
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Mean Change in Amblyopic-eye Visual Acuity (VA) Older Cohort | Baseline and 4 weeks | The primary objective is to compare the efficacy of 4 weeks of treatment with 1 hour/day of binocular game play 5 days per week plus spectacle correction to treatment with spectacle correction alone (control). Monocular distance visual acuity (VA) in current refractive correction (if required) in each eye by a certified examiner using the Electronic Early Treatment Diabetic Retinoscopy Study (E-ETDRS) visual acuity protocol for children ≥ 7 years on a study-certified acuity tester displaying single surrounded optotypes. For the analyses in the older cohort, the level of VA is measured as letter scores (approximate range: 0 to 97 letters, lower scores indicate poorer VA) and change in VA from baseline is measured in letters (positive values indicate improvement), defined as the difference in letter scores between enrollment and follow-up. Adjusted values have been adjusted for amblyopic-eye visual acuity at randomization. |
| Mean Visual Acuity (VA) in Amblyopic-eye (Older Cohort) | 4 weeks | Monocular distance visual acuity (VA) in current refractive correction (if required) in each eye by a certified examiner using the Electronic Early Treatment Diabetic Retinoscopy Study (E-ETDRS) visual acuity protocol for children ≥ 7 years on a study-certified acuity tester displaying single surrounded optotypes. For the analyses in the older cohort, the level of VA is measured as letter scores (approximate range: 0 to 97 letters, lower scores indicate poorer VA) and change in VA from baseline is measured in letters (positive values indicate improvement), defined as the difference in letter scores between enrollment and follow-up. |
| Mean Change in Amblyopic-eye Visual Acuity (VA) in Older Cohort | Baseline and 8 weeks | Monocular distance visual acuity (VA) in current refractive correction (if required) in each eye by a certified examiner using the Electronic Early Treatment Diabetic Retinoscopy Study (E-ETDRS) visual acuity protocol for children ≥ 7 years on a study-certified acuity tester displaying single surrounded optotypes. For the analyses in the older cohort, the level of VA is measured as letter scores (approximate range: 0 to 97 letters, lower scores indicate poorer VA) and change in VA from baseline is measured in letters (positive values indicate improvement), defined as the difference in letter scores between enrollment and follow-up. |
| Mean Change in Amblyopic-eye Visual Acuity (VA) Younger Cohort | baseline and 4 weeks | The primary objective is to compare the efficacy of 4 weeks of treatment with 1 hour/day of binocular game play 5 days per week plus spectacle correction to treatment with spectacle correction alone (control). Monocular distance visual acuity (VA) in current refractive correction (if required) in each eye by a certified examiner using the Electronic Early Treatment Diabetic Retinoscopy Study (E-ETDRS) visual acuity protocol for children ≥ 7 years on a study-certified acuity tester displaying single surrounded optotypes. For the analyses in the younger cohort, the level of VA is measured in logMAR (approximate range: -0.2 to 1.2, lower scores indicate better VA) and change in VA from baseline is measured in logMAR lines (positive values indicate improvement), defined as 10 times the difference in logMAR between enrollment and follow-up. Adjusted values have been adjusted for amblyopic-eye visual acuity at randomization. |
| Mean Visual Acuity (VA) in Amblyopic-eye (Younger Cohort) | 4 weeks | Monocular distance visual acuity (VA) in current refractive correction (if required) in each eye by a certified examiner using the Electronic Early Treatment Diabetic Retinoscopy Study (E-ETDRS) visual acuity protocol for children ≥ 7 years on a study-certified acuity tester displaying single surrounded optotypes. For the analyses in the younger cohort, the level of VA is measured in logMAR (approximate range: -0.2 to 1.2, lower scores indicate better VA) and change in VA from baseline is measured in logMAR lines (positive values indicate improvement), defined as 10 times the difference in logMAR between enrollment and follow-up. |
| Mean Change in Amblyopic-eye Visual Acuity (VA) in Younger Cohort | Baseline and 8 weeks | Monocular distance visual acuity (VA) in current refractive correction (if required) in each eye by a certified examiner using the Electronic Early Treatment Diabetic Retinoscopy Study (E-ETDRS) visual acuity protocol for children ≥ 7 years on a study-certified acuity tester displaying single surrounded optotypes. For the analyses in the younger cohort, the level of VA is measured in logMAR (approximate range: -0.2 to 1.2, lower scores indicate better VA) and change in VA from baseline is measured in logMAR lines (positive values indicate improvement), defined as 10 times the difference in logMAR between enrollment and follow-up. |
| Primary Outcome Measure (Older Cohort) Stratified by Sex | 4 Weeks | NIH-required analysis, stratified by sex. The primary objective is to compare the efficacy of 4 weeks of treatment with 1 hour/day of binocular game play 5 days per week plus spectacle correction to treatment with spectacle correction alone (control). Monocular distance visual acuity (VA) in current refractive correction (if required) in each eye by a certified examiner using the Electronic Early Treatment Diabetic Retinoscopy Study (E-ETDRS) visual acuity protocol for children ≥ 7 years on a study-certified acuity tester displaying single surrounded optotypes. For the analyses in the older cohort, the level of VA is measured as letter scores (approximate range: 0 to 97 letters, lower scores indicate poorer VA) and change in VA from baseline is measured in letters (positive values indicate improvement), defined as the difference in letter scores between enrollment and follow-up. Adjusted values have been adjusted for amblyopic-eye visual acuity at randomization. |
| Primary Outcome Measure (Older Cohort) Stratified by Race/Ethnicity | 4 Weeks | NIH-required analysis, stratified by race/ethnicity. The primary objective is to compare the efficacy of 4 weeks of treatment with 1 hour/day of binocular game play 5 days per week plus spectacle correction to treatment with spectacle correction alone (control). Monocular distance visual acuity (VA) in current refractive correction (if required) in each eye by a certified examiner using the Electronic Early Treatment Diabetic Retinoscopy Study (E-ETDRS) visual acuity protocol for children ≥ 7 years on a study-certified acuity tester displaying single surrounded optotypes. For the analyses in the older cohort, the level of VA is measured as letter scores (approximate range: 0 to 97 letters, lower scores indicate poorer VA) and change in VA from baseline is measured in letters (positive values indicate improvement), defined as the difference in letter scores between enrollment and follow-up. Adjusted values have been adjusted for amblyopic-eye visual acuity at randomization. |
| Primary Outcome Measure (Younger Cohort) Stratified by Sex | 4 Weeks | NIH-required analysis, stratified by sex. The primary objective is to compare the efficacy of 4 weeks of treatment with 1 hour/day of binocular game play 5 days per week plus spectacle correction to treatment with spectacle correction alone (control). Monocular distance visual acuity (VA) in current refractive correction (if required) in each eye by a certified examiner using the Electronic Early Treatment Diabetic Retinoscopy Study (E-ETDRS) visual acuity protocol for children ≥ 7 years on a study-certified acuity tester displaying single surrounded optotypes. For the analyses in the younger cohort, the level of VA is measured in logMAR (approximate range: -0.2 to 1.2, lower scores indicate better VA) and change in VA from baseline is measured in logMAR lines (positive values indicate improvement), defined as 10 times the difference in logMAR between enrollment and follow-up. Adjusted values have been adjusted for amblyopic-eye visual acuity at randomization. |
| Primary Outcome Measure (Younger Cohort) Stratified by Race/Ethnicity | 4 Weeks | NIH-required analysis, stratified by race/ethnicity. The primary objective is to compare the efficacy of 4 weeks of treatment with 1 hour/day of binocular game play 5 days per week plus spectacle correction to treatment with spectacle correction alone (control). Monocular distance visual acuity (VA) in current refractive correction (if required) in each eye by a certified examiner using the Electronic Early Treatment Diabetic Retinoscopy Study (E-ETDRS) visual acuity protocol for children ≥ 7 years on a study-certified acuity tester displaying single surrounded optotypes. For the analyses in the younger cohort, the level of VA is measured in logMAR (approximate range: -0.2 to 1.2, lower scores indicate better VA) and change in VA from baseline is measured in logMAR lines (positive values indicate improvement), defined as 10 times the difference in logMAR between enrollment and follow-up. Adjusted values have been adjusted for amblyopic-eye visual acuity at randomization. |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| VA Improvement at 4 Weeks Defined as a Binary Outcome | At 4 weeks | A secondary analysis will estimate the proportion of subjects with amblyopic-eye VA improvement of ≥ 2 logMAR lines (≥ 10 letters if E-ETDRS) at 4 weeks after baseline. |
| VA Improvement at 8 Weeks Defined as a Binary Outcome | At 8 weeks | A secondary analysis will estimate the proportion of subjects with amblyopic-eye VA improvement of ≥ 2 logMAR lines (≥ 10 letters if E-ETDRS) at 8 weeks after baseline. |
| Distribution of Stereoacuity Scores at 4 Weeks | 4 weeks | Stereoacuity will be tested at near in current refractive correction using the Randot Butterfly and Randot Preschool stereoacuity tests. Stereoacuity scores (measure as seconds of arc) were calculated based on the Randot Butterfly (scores: 2000, Nil) and Randot Preschool stereoacuity (scores: 800, 400, 200, 100, 60 and 40) test methods. Lower scores indicate better stereoacuity. Results of the Randot Butterfly test were analyzed as 2000 seconds of arc (if correct response). Nil was assigned a score of 4000 seconds of arc and was defined as (1) an incorrect response on the butterfly in absence of a correct response on the 800 seconds of arc level of the Randot Preschool stereoacuity test or (2) an incorrect response on the 800 seconds of arc level if the butterfly was not attempted. |
| Distribution of Change in Stereoacuity Scores From Baseline | 4 weeks | Stereoacuity was tested at near in current refractive correction. Stereoacuity scores (seconds of arc) were calculated based on the Randot Butterfly (scores: 2000, Nil) and Randot Preschool stereoacuity (scores: 800, 400, 200, 100, 60 and 40) test methods. Lower scores indicate better stereoacuity. Results of the Randot Butterfly test were analyzed as 2000 (if correct response). Nil (4000) was defined as (1) an incorrect response on the butterfly in absence of a correct response on the 800 seconds of arc level of the Randot Preschool stereoacuity test or (2) an incorrect response on the 800 seconds of arc level if the butterfly was not attempted. For each visit, stereoacuity scores were ordered and assigned a rank score. Change in stereoacuity was calculated as the difference in ranked score between the enrollment and 4-week stereoacuity scores. |
| Distribution of Stereoacuity Scores at 8 Weeks | 8 weeks | Stereoacuity will be tested at near in current refractive correction using the Randot Butterfly and Randot Preschool stereoacuity tests. Stereoacuity scores (measure as seconds of arc) were calculated based on the Randot Butterfly (scores: 2000, Nil) and Randot Preschool stereoacuity (scores: 800, 400, 200, 100, 60 and 40) test methods. Lower scores indicate better stereoacuity. Results of the Randot Butterfly test were analyzed as 2000 seconds of arc (if correct response). Nil was assigned a score of 4000 seconds of arc and was defined as (1) an incorrect response on the butterfly in absence of a correct response on the 800 seconds of arc level of the Randot Preschool stereoacuity test or (2) an incorrect response on the 800 seconds of arc level if the butterfly was not attempted. |
| Distribution of Stereoacuity Scores (Participants With no History of Strabismus) | 4 weeks | Stereoacuity was tested at near in current refractive correction. Stereoacuity scores (measure as seconds of arc) were calculated based on the Randot Butterfly (scores: 2000, Nil) and Randot Preschool stereoacuity (scores: 800, 400, 200, 100, 60 and 40) test methods. Lower scores indicate better stereoacuity. Results of the Randot Butterfly test were analyzed as 2000 seconds of arc (if correct response). Nil was assigned a score of 4000 seconds of arc and was defined as (1) an incorrect response on the butterfly in absence of a correct response on the 800 seconds of arc level of the Randot Preschool stereoacuity test or (2) an incorrect response on the 800 seconds of arc level if the butterfly was not attempted. |
| Distribution of Change in Stereoacuity Scores From Baseline (Participants With no History of Strabismus) | 4 weeks | Stereoacuity was tested at near in current refractive correction. Stereoacuity scores (seconds of arc) were calculated based on the Randot Butterfly (scores: 2000, Nil) and Randot Preschool stereoacuity (scores: 800, 400, 200, 100, 60 and 40) test methods. Lower scores indicate better stereoacuity. Results of the Randot Butterfly test were analyzed as 2000 (if correct response). Nil (4000) was defined as (1) an incorrect response on the butterfly in absence of a correct response on the 800 seconds of arc level of the Randot Preschool stereoacuity test or (2) an incorrect response on the 800 seconds of arc level if the butterfly was not attempted. For each visit, stereoacuity scores were ordered and assigned a rank score. Change in stereoacuity was calculated as the difference in ranked score between the enrollment and 4-week stereoacuity scores. |
| Binocular Therapy: Treatment Compliance and Fellow-Eye Contrast | 4 weeks | Data from the automated iPad log files will be used to provide an objective measure of compliance with binocular treatment (participants completion of \>75% of prescribed game play). The total amount of game play will be computed for the initial 4 weeks of treatment for the binocular treatment group, as well as throughout 8 weeks. Secondary analyses will evaluate the relationship between the total amount of game play with (1) change in VA and (2) change in stereoacuity after the first 4 weeks of binocular treatment. Data from the automated iPad log files will also be used to assess game performance as measured by the fellow-eye contrast. |
| Treatment Compliance With Spectacle Wear | 4 weeks | Parent-reported adherence with spectacle wear (excluding participants with reported compliance of 'N/A') for the initial 4 weeks. Patient reported to have completed \>75% of spectacle wear at 4 weeks. |
| Mean Change in Fellow Eye Visual Acuity at 4 Weeks (Older Cohort) | Baseline and 4 weeks | The mean change in fellow-eye VA from baseline to 4 weeks will be calculated and compared between treatment groups using ANCOVA with adjustment for baseline VA. |
| Mean Change in Fellow Eye VA at 8 Weeks (Older Cohort) | Baseline and 8 weeks | The mean change in fellow-eye VA from baseline to 8 weeks will be calculated and compared between treatment groups using ANCOVA with adjustment for baseline VA. |
| Ocular Alignment at 4 Weeks | 4 weeks | The proportion of subjects with development of new strabismus (no heterotropia at baseline and the presence of near and/or distance heterotropia at 4 weeks) or an increase from baseline ≥10∆ in a pre-existing strabismus at 4 weeks will be reported by treatment group and compared using Barnard's exact test. Ocular alignment will be assessed in current refractive correction by the cover/uncover test, simultaneous prism and cover test (SPCT), and prism and alternate cover test (PACT) in primary gaze at distance (3 meters) and at near (1/3 meter). Participants were classified according to whether they met the any of the following criteria at the 4-week visit: development of a new tropia (measured by SPCT) and/or worsening of a pre-existing deviation by 10 prism diopters (pd) measured by SPCT. |
| Ocular Alignment at 8 Weeks | 8 weeks | The proportion of subjects with development of new strabismus (no heterotropia at baseline and the presence of near and/or distance heterotropia at 8 weeks) or an increase from baseline ≥10∆ in a pre-existing strabismus at 8 weeks will be reported by treatment group and compared using Barnard's exact test. Ocular alignment will be assessed in current refractive correction by the cover/uncover test, simultaneous prism and cover test (SPCT), and prism and alternate cover test (PACT) in primary gaze at distance (3 meters) and at near (1/3 meter). Participants were classified according to whether they met the any of the following criteria at the 8-week visit: development of a new tropia (measured by SPCT) and/or worsening of a pre-existing deviation by 10 prism diopters (pd) measured by SPCT. |
| Distribution of Diplopia Frequency at 4 Weeks (Participant-reported) | 4 weeks | The proportion of subjects with each level of diplopia frequency will be reported by treatment group at 4 weeks. A standardized questionnaire was administered to participants and their parents to assess the presence and frequency of any diplopia since the last study visit. |
| Distribution of Diplopia Frequency at 8 Weeks (Participant-reported) | 8 weeks | The proportion of subjects with each level of diplopia frequency will be reported by treatment group at 8 weeks. A standardized questionnaire was administered to participants and their parents to assess the presence and frequency of any diplopia since the last study visit. |
| Change in Diplopia Frequency From Baseline to 4 Weeks (Participant-reported) | 4 weeks | A standardized questionnaire was administered to participants and their parents to assess the presence and frequency of any diplopia since the last study visit. Change in diplopia frequency from baseline to 4 weeks was reported categorically. |
| Change in Diplopia Frequency From Baseline to 8 Weeks (Participant-reported) | 8 weeks | A standardized questionnaire was administered to participants and their parents to assess the presence and frequency of any diplopia since the last study visit. Change in diplopia frequency from baseline to 8 weeks was reported categorically. |
| Distribution of Diplopia Frequency at 4 Weeks (Parent-reported) | 4 weeks | The proportion of subjects with each level of diplopia frequency will be reported by treatment group at 4 weeks. A standardized questionnaire was administered to participants and their parents to assess the presence and frequency of any diplopia since the last study visit. |
| Distribution of Diplopia Frequency at 8 Weeks (Parent-reported) | 8 weeks | The proportion of subjects with each level of diplopia frequency will be reported by treatment group at 8 weeks. A standardized questionnaire was administered to participants and their parents to assess the presence and frequency of any diplopia since the last study visit. |
| Change in Diplopia Frequency From Baseline to 4 Weeks (Parent-reported) | 4 weeks | A standardized questionnaire was administered to participants and their parents to assess the presence and frequency of any diplopia since the last study visit. Change in diplopia frequency from baseline to 4 weeks was reported categorically. |
| Change in Diplopia Frequency From Baseline to 8 Weeks (Parent-reported) | 8 weeks | A standardized questionnaire was administered to participants and their parents to assess the presence and frequency of any diplopia since the last study visit. Change in diplopia frequency from baseline to 8 weeks was reported categorically. |
| Frequency of Adverse Symptoms (Symptom Survey) | 4 weeks | The child and parent(s) will complete a 5-item symptom survey regarding the presence of various ocular symptoms within the past 2 weeks at enrollment and at each visit. The distribution of scores on each symptom survey item will be described for the enrollment exam and the 4-week exam for each treatment group. The distribution of change in scores on each symptom survey item will also be described for each treatment group. |
| Frequency of Adverse Symptoms (Symptom Survey) at 8 Weeks | 8 weeks | The child and parent(s) will complete a 5-item symptom survey regarding the presence of various ocular symptoms within the past 2 weeks at enrollment and at each visit. The distribution of scores on each symptom survey item will be described for the enrollment exam and the 4-week exam for each treatment group. The distribution of change in scores on each symptom survey item will also be described for each treatment group. |
| Distribution of Change in Adverse Symptom Frequency (Symptom Survey) From Baseline to 4 Weeks | 4 weeks | The child and parent(s) will complete a 5-item symptom survey regarding the presence of various ocular symptoms within the past 2 weeks at enrollment and at each visit. The distribution of scores on each symptom survey item will be described for the enrollment exam and the 4-week exam for each treatment group. The distribution of change in scores on each symptom survey item will also be described for each treatment group. |
| Distribution of Change in Adverse Symptom Frequency (Symptom Survey) From Baseline to 8 Weeks | 8 weeks | The child and parent(s) will complete a 5-item symptom survey regarding the presence of various ocular symptoms within the past 2 weeks at enrollment and at each visit. The distribution of scores on each symptom survey item will be described for the enrollment exam and the 8-week exam for each treatment group. The distribution of change in scores on each symptom survey item will also be described for each treatment group. |
| Mean Change in Fellow Eye Visual Acuity at 4 Weeks (Younger Cohort) | Baseline and 4 weeks | The mean change in fellow-eye VA from baseline to 4 weeks will be calculated and compared between treatment groups using ANCOVA with adjustment for baseline VA. |
| Mean Change in Fellow Eye VA at 8 Weeks (Younger Cohort) | baseline and 8 weeks | The mean change in fellow-eye VA from baseline to 8 weeks will be calculated and compared between treatment groups using ANCOVA with adjustment for baseline VA. |
Countries
Canada, United States
Contacts
STUDY_CHAIRRuth Manny, OD, PhD
University of Houston College of Optometry
STUDY_CHAIRJonathan Holmes, MD
Mayo Clinic
Participant flow
Recruitment details
138 is the number of subjects from the older cohort study. 182 is the number of subjects from the younger cohort.
Participants by arm
| Arm | Count |
|---|---|
| Binocular Computer Game Treatment Older Cohort Binocular computer game treatment is defined as playing a Dig Rush application on an iPad® 1 hour per day, 5 days per week for 8 weeks in addition to continued spectacle correction (if required)
iPad®: Binocular therapy using a Dig Rush application on an iPad® | 69 |
| Continued Spectacle Correction Older Cohort Continued spectacle correction is defined as wearing appropriate spectacle correction (if required) for all waking hours, 7 days per week for 8 weeks.
Spectacle correction: Spectacle correction for all waking hours, 7 days per week | 69 |
| Binocular Computer Game Treatment Younger Cohort Binocular computer game treatment is defined as playing a Dig Rush application on an iPad® 1 hour per day, 5 days per week for 8 weeks in addition to continued spectacle correction (if required)
iPad®: Binocular therapy using a Dig Rush application on an iPad® | 92 |
| Continued Spectacle Correction Younger Cohort Continued spectacle correction is defined as wearing appropriate spectacle correction (if required) for all waking hours, 7 days per week for 8 weeks.
Spectacle correction: Spectacle correction for all waking hours, 7 days per week | 90 |
| Total | 320 |
Baseline characteristics
| Characteristic | Binocular Computer Game Treatment Older Cohort | Continued Spectacle Correction Older Cohort | Binocular Computer Game Treatment Younger Cohort | Continued Spectacle Correction Younger Cohort | Total |
|---|---|---|---|---|---|
| Age, Categorical <=18 years | 69 Participants | 69 Participants | 92 Participants | 90 Participants | 320 Participants |
| Age, Categorical >=65 years | 0 Participants | 0 Participants | 0 Participants | 0 Participants | 0 Participants |
| Age, Categorical Between 18 and 65 years | 0 Participants | 0 Participants | 0 Participants | 0 Participants | 0 Participants |
| Age, Continuous | 9.6 years STANDARD_DEVIATION 1.6 | 9.6 years STANDARD_DEVIATION 1.5 | 5.8 years STANDARD_DEVIATION 0.7 | 5.7 years STANDARD_DEVIATION 0.7 | 7.4 years STANDARD_DEVIATION 2.2 |
| Age, Customized Age Range 10 to <13 years | 24 Participants | 24 Participants | 0 Participants | 0 Participants | 48 Participants |
| Age, Customized Age Range 4 to <5 years | 0 Participants | 0 Participants | 12 Participants | 17 Participants | 29 Participants |
| Age, Customized Age Range 5 to <6 years | 0 Participants | 0 Participants | 39 Participants | 41 Participants | 80 Participants |
| Age, Customized Age Range 6 to <7 years | 0 Participants | 0 Participants | 41 Participants | 32 Participants | 73 Participants |
| Age, Customized Age Range 7 to <10 years | 45 Participants | 45 Participants | 0 Participants | 0 Participants | 90 Participants |
| Amblyopia Cause Anisometropia | 27 Participants | 39 Participants | 61 Participants | 54 Participants | 181 Participants |
| Amblyopia Cause Combined-mechanism | 27 Participants | 19 Participants | 16 Participants | 21 Participants | 83 Participants |
| Amblyopia Cause Strabismus | 15 Participants | 11 Participants | 15 Participants | 15 Participants | 56 Participants |
| Amblyopic-eye Spherical Equivalent (Diopters) | 4.35 Diopters STANDARD_DEVIATION 2.42 | 4.40 Diopters STANDARD_DEVIATION 2.28 | 4.49 Diopters STANDARD_DEVIATION 1.75 | 4.45 Diopters STANDARD_DEVIATION 2.76 | 4.43 Diopters STANDARD_DEVIATION 2.32 |
| Distance Amblyopic-eye VA | 0.50 logMAR STANDARD_DEVIATION 0.16 | 0.52 logMAR STANDARD_DEVIATION 0.16 | 0.48 logMAR STANDARD_DEVIATION 0.16 | 0.48 logMAR STANDARD_DEVIATION 0.17 | 0.49 logMAR STANDARD_DEVIATION 0.16 |
| Distance Amblyopic-eye VA (Letter Score) 20/100 | 8 Participants | 8 Participants | 3 Participants | 4 Participants | 23 Participants |
| Distance Amblyopic-eye VA (Letter Score) 20/125 | 3 Participants | 3 Participants | 7 Participants | 3 Participants | 16 Participants |
| Distance Amblyopic-eye VA (Letter Score) 20/160 | 2 Participants | 2 Participants | 2 Participants | 3 Participants | 9 Participants |
| Distance Amblyopic-eye VA (Letter Score) 20/200 | 0 Participants | 0 Participants | 1 Participants | 2 Participants | 3 Participants |
| Distance Amblyopic-eye VA (Letter Score) 20/40 | 16 Participants | 15 Participants | 19 Participants | 19 Participants | 69 Participants |
| Distance Amblyopic-eye VA (Letter Score) 20/50 | 11 Participants | 10 Participants | 27 Participants | 26 Participants | 74 Participants |
| Distance Amblyopic-eye VA (Letter Score) 20/63 | 19 Participants | 14 Participants | 24 Participants | 24 Participants | 81 Participants |
| Distance Amblyopic-eye VA (Letter Score) 20/80 | 10 Participants | 17 Participants | 9 Participants | 9 Participants | 45 Participants |
| Distance Fellow-eye VA | -0.058 logMAR STANDARD_DEVIATION 0.079 | -0.058 logMAR STANDARD_DEVIATION 0.074 | 0.002 logMAR STANDARD_DEVIATION 0.083 | -0.003 logMAR STANDARD_DEVIATION 0.085 | -0.025 logMAR STANDARD_DEVIATION 0.086 |
| Distance SPCT: Maximum angle of deviation >=10 prism diopters | 2 Participants | 2 Participants | 1 Participants | 1 Participants | 6 Participants |
| Distance SPCT: Maximum angle of deviation 1 to 4 prism diopters | 18 Participants | 15 Participants | 15 Participants | 11 Participants | 59 Participants |
| Distance SPCT: Maximum angle of deviation 5 to 9 prism diopters | 2 Participants | 2 Participants | 3 Participants | 2 Participants | 9 Participants |
| Distance SPCT: Maximum angle of deviation Orthotropic | 47 Participants | 50 Participants | 73 Participants | 76 Participants | 246 Participants |
| Fellow-eye Spherical Equivalent (Diopters) | 2.10 Diopters STANDARD_DEVIATION 2.12 | 2.22 Diopters STANDARD_DEVIATION 1.99 | 2.41 Diopters STANDARD_DEVIATION 1.67 | 2.67 Diopters STANDARD_DEVIATION 1.99 | 2.38 Diopters STANDARD_DEVIATION 1.93 |
| Interocular Difference (Lines) | 5.57 Lines STANDARD_DEVIATION 1.83 | 5.75 Lines STANDARD_DEVIATION 1.86 | 4.80 Lines STANDARD_DEVIATION 4.86 | 1.71 Lines STANDARD_DEVIATION 1.7 | 5.19 Lines STANDARD_DEVIATION 1.81 |
| Near SPCT: Maximum angle of deviation 1 to 4 prism diopters | 25 Participants | 22 Participants | 20 Participants | 15 Participants | 82 Participants |
| Near SPCT: Maximum angle of deviation Orthotropic | 44 Participants | 47 Participants | 72 Participants | 75 Participants | 238 Participants |
| Prior Amblyopia Treatment Atropine | 0 Participants | 1 Participants | 2 Participants | 2 Participants | 5 Participants |
| Prior Amblyopia Treatment None | 4 Participants | 2 Participants | 33 Participants | 32 Participants | 71 Participants |
| Prior Amblyopia Treatment Patching | 34 Participants | 36 Participants | 39 Participants | 40 Participants | 149 Participants |
| Prior Amblyopia Treatment Patching/Atropine | 26 Participants | 21 Participants | 15 Participants | 15 Participants | 77 Participants |
| Prior Amblyopia Treatment Patching/Atropine/Other | 2 Participants | 7 Participants | 2 Participants | 0 Participants | 11 Participants |
| Prior Amblyopia Treatment Patching/Other | 3 Participants | 2 Participants | 1 Participants | 1 Participants | 7 Participants |
| Prior Binocular Treatment | 1 Participants | 4 Participants | 0 Participants | 0 Participants | 5 Participants |
| Race/Ethnicity, Customized Asian | 6 Participants | 1 Participants | 1 Participants | 2 Participants | 10 Participants |
| Race/Ethnicity, Customized Black/African American | 3 Participants | 2 Participants | 2 Participants | 5 Participants | 12 Participants |
| Race/Ethnicity, Customized Hispanic | 9 Participants | 8 Participants | 12 Participants | 8 Participants | 37 Participants |
| Race/Ethnicity, Customized More than one race | 1 Participants | 2 Participants | 2 Participants | 1 Participants | 6 Participants |
| Race/Ethnicity, Customized Unknown/not reported | 0 Participants | 1 Participants | 0 Participants | 0 Participants | 1 Participants |
| Race/Ethnicity, Customized White | 50 Participants | 55 Participants | 75 Participants | 74 Participants | 254 Participants |
| Sex: Female, Male Female | 30 Participants | 35 Participants | 50 Participants | 46 Participants | 161 Participants |
| Sex: Female, Male Male | 39 Participants | 34 Participants | 42 Participants | 44 Participants | 159 Participants |
| Spherical Equivalent Anisometropia (Diopters) | 2.29 Diopters STANDARD_DEVIATION 1.79 | 2.27 Diopters STANDARD_DEVIATION 1.62 | 2.12 Diopters STANDARD_DEVIATION 1.52 | 2.25 Diopters STANDARD_DEVIATION 1.51 | 2.22 Diopters STANDARD_DEVIATION 1.59 |
| Stereoacuity: Nil | 33 Participants | 33 Participants | 29 Participants | 28 Participants | 123 Participants |
| Stereoacuity (Seconds of Arc) | 2000 Seconds of Arc | 2000 Seconds of Arc | 800 Seconds of Arc | 800 Seconds of Arc | 2000 Seconds of Arc |
Adverse events
| Event type | EG000 affected / at risk | EG001 affected / at risk | EG002 affected / at risk | EG003 affected / at risk |
|---|---|---|---|---|
| deaths Total, all-cause mortality | 0 / 69 | 0 / 69 | 0 / 92 | 0 / 90 |
| other Total, other adverse events | 0 / 69 | 0 / 69 | 0 / 92 | 0 / 90 |
| serious Total, serious adverse events | 0 / 69 | 0 / 69 | 0 / 92 | 0 / 90 |
Outcome results
Primary
Mean Change in Amblyopic-eye Visual Acuity (VA) in Older Cohort
Monocular distance visual acuity (VA) in current refractive correction (if required) in each eye by a certified examiner using the Electronic Early Treatment Diabetic Retinoscopy Study (E-ETDRS) visual acuity protocol for children ≥ 7 years on a study-certified acuity tester displaying single surrounded optotypes. For the analyses in the older cohort, the level of VA is measured as letter scores (approximate range: 0 to 97 letters, lower scores indicate poorer VA) and change in VA from baseline is measured in letters (positive values indicate improvement), defined as the difference in letter scores between enrollment and follow-up.
Time frame: Baseline and 8 weeks
Population: Two participants (1 per group) were not included with the 8-week visual acuity data. One participant in the control treatment group had visual acuity tested using a non-protocol method and another participant in the binocular treatment group completed the 8-week exam outside of the analysis window (49 to \<105 days from randomization).
| Arm | Measure | Group | Value (MEAN) |
|---|---|---|---|
| Binocular Computer Game Treatment Older Cohort | Mean Change in Amblyopic-eye Visual Acuity (VA) in Older Cohort | Adjusted | 2.3 Letters |
| Binocular Computer Game Treatment Older Cohort | Mean Change in Amblyopic-eye Visual Acuity (VA) in Older Cohort | Unadjusted | 2.3 Letters |
| Continued Spectacle Correction Older Cohort | Mean Change in Amblyopic-eye Visual Acuity (VA) in Older Cohort | Adjusted | 2.4 Letters |
| Continued Spectacle Correction Older Cohort | Mean Change in Amblyopic-eye Visual Acuity (VA) in Older Cohort | Unadjusted | 2.4 Letters |
98.3% CI: [-2.4, 2.1]
Primary
Mean Change in Amblyopic-eye Visual Acuity (VA) in Younger Cohort
Monocular distance visual acuity (VA) in current refractive correction (if required) in each eye by a certified examiner using the Electronic Early Treatment Diabetic Retinoscopy Study (E-ETDRS) visual acuity protocol for children ≥ 7 years on a study-certified acuity tester displaying single surrounded optotypes. For the analyses in the younger cohort, the level of VA is measured in logMAR (approximate range: -0.2 to 1.2, lower scores indicate better VA) and change in VA from baseline is measured in logMAR lines (positive values indicate improvement), defined as 10 times the difference in logMAR between enrollment and follow-up.
Time frame: Baseline and 8 weeks
Population: Two participants (1 per group) were not included with the 8-week visual acuity data. One participant in the control treatment group had visual acuity tested using a non-protocol method and another participant in the binocular treatment group completed the 8-week exam outside of the analysis window (49 to \<105 days from randomization).
| Arm | Measure | Group | Value (MEAN) |
|---|---|---|---|
| Binocular Computer Game Treatment Older Cohort | Mean Change in Amblyopic-eye Visual Acuity (VA) in Younger Cohort | Adjusted | 1.2614 logMAR Lines |
| Binocular Computer Game Treatment Older Cohort | Mean Change in Amblyopic-eye Visual Acuity (VA) in Younger Cohort | Unadjusted | 1.2588 logMAR Lines |
| Continued Spectacle Correction Older Cohort | Mean Change in Amblyopic-eye Visual Acuity (VA) in Younger Cohort | Adjusted | 0.9855 logMAR Lines |
| Continued Spectacle Correction Older Cohort | Mean Change in Amblyopic-eye Visual Acuity (VA) in Younger Cohort | Unadjusted | 0.9981 logMAR Lines |
Primary
Mean Change in Amblyopic-eye Visual Acuity (VA) Older Cohort
The primary objective is to compare the efficacy of 4 weeks of treatment with 1 hour/day of binocular game play 5 days per week plus spectacle correction to treatment with spectacle correction alone (control). Monocular distance visual acuity (VA) in current refractive correction (if required) in each eye by a certified examiner using the Electronic Early Treatment Diabetic Retinoscopy Study (E-ETDRS) visual acuity protocol for children ≥ 7 years on a study-certified acuity tester displaying single surrounded optotypes. For the analyses in the older cohort, the level of VA is measured as letter scores (approximate range: 0 to 97 letters, lower scores indicate poorer VA) and change in VA from baseline is measured in letters (positive values indicate improvement), defined as the difference in letter scores between enrollment and follow-up. Adjusted values have been adjusted for amblyopic-eye visual acuity at randomization.
Time frame: Baseline and 4 weeks
| Arm | Measure | Group | Value (MEAN) |
|---|---|---|---|
| Binocular Computer Game Treatment Older Cohort | Mean Change in Amblyopic-eye Visual Acuity (VA) Older Cohort | Adjusted | 1.3 Letter score |
| Binocular Computer Game Treatment Older Cohort | Mean Change in Amblyopic-eye Visual Acuity (VA) Older Cohort | Unadjusted | 1.3 Letter score |
| Continued Spectacle Correction Older Cohort | Mean Change in Amblyopic-eye Visual Acuity (VA) Older Cohort | Adjusted | 1.7 Letter score |
| Continued Spectacle Correction Older Cohort | Mean Change in Amblyopic-eye Visual Acuity (VA) Older Cohort | Unadjusted | 1.7 Letter score |
Comparison: A modified intent-to-treat analysis was performed using an ANCOVA model to compare the effectiveness of two treatments (2-sided hypothesis test), adjusting for baseline visual acuity. The primary outcome measure was change in amblyopic-eye VA from baseline to 4 weeks. A 2-sided 95% confidence interval (CI) was computed on the adjusted treatment group difference at 4 weeks. There was no imputation for missing data.p-value: 0.7195% CI: [-2.2, 1.7]ANOVA
Primary
Mean Change in Amblyopic-eye Visual Acuity (VA) Younger Cohort
The primary objective is to compare the efficacy of 4 weeks of treatment with 1 hour/day of binocular game play 5 days per week plus spectacle correction to treatment with spectacle correction alone (control). Monocular distance visual acuity (VA) in current refractive correction (if required) in each eye by a certified examiner using the Electronic Early Treatment Diabetic Retinoscopy Study (E-ETDRS) visual acuity protocol for children ≥ 7 years on a study-certified acuity tester displaying single surrounded optotypes. For the analyses in the younger cohort, the level of VA is measured in logMAR (approximate range: -0.2 to 1.2, lower scores indicate better VA) and change in VA from baseline is measured in logMAR lines (positive values indicate improvement), defined as 10 times the difference in logMAR between enrollment and follow-up. Adjusted values have been adjusted for amblyopic-eye visual acuity at randomization.
Time frame: baseline and 4 weeks
| Arm | Measure | Group | Value (MEAN) |
|---|---|---|---|
| Binocular Computer Game Treatment Older Cohort | Mean Change in Amblyopic-eye Visual Acuity (VA) Younger Cohort | Unadjusted | 1.0706 logMAR Lines |
| Binocular Computer Game Treatment Older Cohort | Mean Change in Amblyopic-eye Visual Acuity (VA) Younger Cohort | Adjusted | 1.0724 logMAR Lines |
| Continued Spectacle Correction Older Cohort | Mean Change in Amblyopic-eye Visual Acuity (VA) Younger Cohort | Unadjusted | 0.6071 logMAR Lines |
| Continued Spectacle Correction Older Cohort | Mean Change in Amblyopic-eye Visual Acuity (VA) Younger Cohort | Adjusted | 0.6053 logMAR Lines |
Primary
Mean Visual Acuity (VA) in Amblyopic-eye (Older Cohort)
Monocular distance visual acuity (VA) in current refractive correction (if required) in each eye by a certified examiner using the Electronic Early Treatment Diabetic Retinoscopy Study (E-ETDRS) visual acuity protocol for children ≥ 7 years on a study-certified acuity tester displaying single surrounded optotypes. For the analyses in the older cohort, the level of VA is measured as letter scores (approximate range: 0 to 97 letters, lower scores indicate poorer VA) and change in VA from baseline is measured in letters (positive values indicate improvement), defined as the difference in letter scores between enrollment and follow-up.
Time frame: 8 weeks
Population: Two participants (1 per group) were not included with the 8-week visual acuity data. One participant in the control treatment group had visual acuity tested using a non-protocol method and another participant in the binocular treatment group completed the 8-week exam outside of the analysis window (49 to \<105 days from randomization).
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| Binocular Computer Game Treatment Older Cohort | Mean Visual Acuity (VA) in Amblyopic-eye (Older Cohort) | 25.9 Letter score | Standard Deviation 9.9 |
| Continued Spectacle Correction Older Cohort | Mean Visual Acuity (VA) in Amblyopic-eye (Older Cohort) | 27.7 Letter score | Standard Deviation 10.4 |
Primary
Mean Visual Acuity (VA) in Amblyopic-eye (Older Cohort)
Monocular distance visual acuity (VA) in current refractive correction (if required) in each eye by a certified examiner using the Electronic Early Treatment Diabetic Retinoscopy Study (E-ETDRS) visual acuity protocol for children ≥ 7 years on a study-certified acuity tester displaying single surrounded optotypes. For the analyses in the older cohort, the level of VA is measured as letter scores (approximate range: 0 to 97 letters, lower scores indicate poorer VA) and change in VA from baseline is measured in letters (positive values indicate improvement), defined as the difference in letter scores between enrollment and follow-up.
Time frame: 4 weeks
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| Binocular Computer Game Treatment Older Cohort | Mean Visual Acuity (VA) in Amblyopic-eye (Older Cohort) | 26.6 Letter score | Standard Deviation 10.5 |
| Continued Spectacle Correction Older Cohort | Mean Visual Acuity (VA) in Amblyopic-eye (Older Cohort) | 28.0 Letter score | Standard Deviation 10.7 |
Primary
Mean Visual Acuity (VA) in Amblyopic-eye (Younger Cohort)
Monocular distance visual acuity (VA) in current refractive correction (if required) in each eye by a certified examiner using the Electronic Early Treatment Diabetic Retinoscopy Study (E-ETDRS) visual acuity protocol for children ≥ 7 years on a study-certified acuity tester displaying single surrounded optotypes. For the analyses in the younger cohort, the level of VA is measured in logMAR (approximate range: -0.2 to 1.2, lower scores indicate better VA) and change in VA from baseline is measured in logMAR lines (positive values indicate improvement), defined as 10 times the difference in logMAR between enrollment and follow-up.
Time frame: 4 weeks
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| Binocular Computer Game Treatment Older Cohort | Mean Visual Acuity (VA) in Amblyopic-eye (Younger Cohort) | 0.38 LogMAR | Standard Deviation 0.22 |
| Continued Spectacle Correction Older Cohort | Mean Visual Acuity (VA) in Amblyopic-eye (Younger Cohort) | 0.42 LogMAR | Standard Deviation 0.21 |
Primary
Mean Visual Acuity (VA) in Amblyopic-eye (Younger Cohort)
Monocular distance visual acuity (VA) in current refractive correction (if required) in each eye by a certified examiner using the Electronic Early Treatment Diabetic Retinoscopy Study (E-ETDRS) visual acuity protocol for children ≥ 7 years on a study-certified acuity tester displaying single surrounded optotypes. For the analyses in the younger cohort, the level of VA is measured in logMAR (approximate range: -0.2 to 1.2, lower scores indicate better VA) and change in VA from baseline is measured in logMAR lines (positive values indicate improvement), defined as 10 times the difference in logMAR between enrollment and follow-up.
Time frame: 8 weeks
Population: Two participants (1 per group) were not included with the 8-week visual acuity data. One participant in the control treatment group had visual acuity tested using a non-protocol method and another participant in the binocular treatment group completed the 8-week exam outside of the analysis window (49 to \<105 days from randomization).
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| Binocular Computer Game Treatment Older Cohort | Mean Visual Acuity (VA) in Amblyopic-eye (Younger Cohort) | 0.36 LogMAR | Standard Deviation 0.22 |
| Continued Spectacle Correction Older Cohort | Mean Visual Acuity (VA) in Amblyopic-eye (Younger Cohort) | 0.38 LogMAR | Standard Deviation 0.22 |
Secondary
Binocular Therapy: Treatment Compliance and Fellow-Eye Contrast
Data from the automated iPad log files will be used to assess game performance as measured by the fellow-eye contrast. The level and change in fellow-eye contrast will be computed for the initial 4 weeks of treatment for the binocular treatment group. Secondary analyses will evaluate the relationship between the change in fellow-eye contrast with (1) change in VA and (2) change in stereoacuity after the first 8 weeks of binocular treatment. Data from the automated iPad log files will also be used to assess game performance as measured by the fellow-eye contrast.
Time frame: 8 weeks
Population: Data from automated iPad log files were only able to be retrieved successfully for 81 of 85 participants in the younger cohort.
| Arm | Measure | Group | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|---|
| Binocular Computer Game Treatment Older Cohort | Binocular Therapy: Treatment Compliance and Fellow-Eye Contrast | Completed >75% prescribed game play | 38 Participants |
| Binocular Computer Game Treatment Older Cohort | Binocular Therapy: Treatment Compliance and Fellow-Eye Contrast | Fellow-eye contrast of 100% | 59 Participants |
| Binocular Computer Game Treatment Older Cohort | Binocular Therapy: Treatment Compliance and Fellow-Eye Contrast | Fellow-eye contrast of 20% or worse | 1 Participants |
| Continued Spectacle Correction Older Cohort | Binocular Therapy: Treatment Compliance and Fellow-Eye Contrast | Completed >75% prescribed game play | 35 Participants |
| Continued Spectacle Correction Older Cohort | Binocular Therapy: Treatment Compliance and Fellow-Eye Contrast | Fellow-eye contrast of 100% | 50 Participants |
| Continued Spectacle Correction Older Cohort | Binocular Therapy: Treatment Compliance and Fellow-Eye Contrast | Fellow-eye contrast of 20% or worse | 2 Participants |
Secondary
Binocular Therapy: Treatment Compliance and Fellow-Eye Contrast
Data from the automated iPad log files will be used to provide an objective measure of compliance with binocular treatment (participants completion of \>75% of prescribed game play). The total amount of game play will be computed for the initial 4 weeks of treatment for the binocular treatment group, as well as throughout 8 weeks. Secondary analyses will evaluate the relationship between the total amount of game play with (1) change in VA and (2) change in stereoacuity after the first 4 weeks of binocular treatment. Data from the automated iPad log files will also be used to assess game performance as measured by the fellow-eye contrast.
Time frame: 4 weeks
Population: The control group was not prescribed binocular therapy, which is why they were not included here.
| Arm | Measure | Group | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|---|
| Binocular Computer Game Treatment Older Cohort | Binocular Therapy: Treatment Compliance and Fellow-Eye Contrast | Completed >75% prescribed game play | 40 Participants |
| Binocular Computer Game Treatment Older Cohort | Binocular Therapy: Treatment Compliance and Fellow-Eye Contrast | Fellow-eye contrast of 100% | 30 Participants |
| Binocular Computer Game Treatment Older Cohort | Binocular Therapy: Treatment Compliance and Fellow-Eye Contrast | Fellow-eye contrast of 20% or worse | 1 Participants |
| Continued Spectacle Correction Older Cohort | Binocular Therapy: Treatment Compliance and Fellow-Eye Contrast | Completed >75% prescribed game play | 37 Participants |
| Continued Spectacle Correction Older Cohort | Binocular Therapy: Treatment Compliance and Fellow-Eye Contrast | Fellow-eye contrast of 100% | 32 Participants |
| Continued Spectacle Correction Older Cohort | Binocular Therapy: Treatment Compliance and Fellow-Eye Contrast | Fellow-eye contrast of 20% or worse | 3 Participants |
Secondary
Change in Diplopia Frequency From Baseline to 4 Weeks (Parent-reported)
A standardized questionnaire was administered to participants and their parents to assess the presence and frequency of any diplopia since the last study visit. Change in diplopia frequency from baseline to 4 weeks was reported categorically.
Time frame: 4 weeks
Population: As this was a safety outcome, all visit information was recorded, regardless of whether or not it was collected in the analysis window.
| Arm | Measure | Group | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|---|
| Binocular Computer Game Treatment Older Cohort | Change in Diplopia Frequency From Baseline to 4 Weeks (Parent-reported) | Reduced frequency (≥ 2 levels) | 0 Participants |
| Binocular Computer Game Treatment Older Cohort | Change in Diplopia Frequency From Baseline to 4 Weeks (Parent-reported) | Increased frequency (≥ 2 levels) | 0 Participants |
| Binocular Computer Game Treatment Older Cohort | Change in Diplopia Frequency From Baseline to 4 Weeks (Parent-reported) | Similar frequency (within 1 level) | 69 Participants |
| Continued Spectacle Correction Older Cohort | Change in Diplopia Frequency From Baseline to 4 Weeks (Parent-reported) | Increased frequency (≥ 2 levels) | 0 Participants |
| Continued Spectacle Correction Older Cohort | Change in Diplopia Frequency From Baseline to 4 Weeks (Parent-reported) | Similar frequency (within 1 level) | 66 Participants |
| Continued Spectacle Correction Older Cohort | Change in Diplopia Frequency From Baseline to 4 Weeks (Parent-reported) | Reduced frequency (≥ 2 levels) | 0 Participants |
| Binocular Computer Game Treatment Younger Cohort | Change in Diplopia Frequency From Baseline to 4 Weeks (Parent-reported) | Reduced frequency (≥ 2 levels) | 0 Participants |
| Binocular Computer Game Treatment Younger Cohort | Change in Diplopia Frequency From Baseline to 4 Weeks (Parent-reported) | Similar frequency (within 1 level) | 88 Participants |
| Binocular Computer Game Treatment Younger Cohort | Change in Diplopia Frequency From Baseline to 4 Weeks (Parent-reported) | Increased frequency (≥ 2 levels) | 0 Participants |
| Continued Spectacle Correction Younger Cohort | Change in Diplopia Frequency From Baseline to 4 Weeks (Parent-reported) | Reduced frequency (≥ 2 levels) | 1 Participants |
| Continued Spectacle Correction Younger Cohort | Change in Diplopia Frequency From Baseline to 4 Weeks (Parent-reported) | Similar frequency (within 1 level) | 82 Participants |
| Continued Spectacle Correction Younger Cohort | Change in Diplopia Frequency From Baseline to 4 Weeks (Parent-reported) | Increased frequency (≥ 2 levels) | 0 Participants |
Comparison: The exact Wilcoxon rank-sum test was used to compare the change in diplopia frequency levels from baseline to the 4-week visit by treatment group.p-value: 0.12Wilcoxon (Mann-Whitney)
Secondary
Change in Diplopia Frequency From Baseline to 4 Weeks (Participant-reported)
A standardized questionnaire was administered to participants and their parents to assess the presence and frequency of any diplopia since the last study visit. Change in diplopia frequency from baseline to 4 weeks was reported categorically.
Time frame: 4 weeks
Population: As this was a safety outcome, all visit information was recorded, regardless of whether or not it was collected in the analysis window. There was 1 missing participant-reported diplopia frequency at baseline in the Binocular Younger cohort.
| Arm | Measure | Group | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|---|
| Binocular Computer Game Treatment Older Cohort | Change in Diplopia Frequency From Baseline to 4 Weeks (Participant-reported) | Reduced frequency (≥ 2 levels) | 2 Participants |
| Binocular Computer Game Treatment Older Cohort | Change in Diplopia Frequency From Baseline to 4 Weeks (Participant-reported) | Similar frequency (within 1 level) | 64 Participants |
| Binocular Computer Game Treatment Older Cohort | Change in Diplopia Frequency From Baseline to 4 Weeks (Participant-reported) | Increased frequency (≥ 2 levels) | 3 Participants |
| Continued Spectacle Correction Older Cohort | Change in Diplopia Frequency From Baseline to 4 Weeks (Participant-reported) | Reduced frequency (≥ 2 levels) | 1 Participants |
| Continued Spectacle Correction Older Cohort | Change in Diplopia Frequency From Baseline to 4 Weeks (Participant-reported) | Increased frequency (≥ 2 levels) | 2 Participants |
| Continued Spectacle Correction Older Cohort | Change in Diplopia Frequency From Baseline to 4 Weeks (Participant-reported) | Similar frequency (within 1 level) | 64 Participants |
| Binocular Computer Game Treatment Younger Cohort | Change in Diplopia Frequency From Baseline to 4 Weeks (Participant-reported) | Increased frequency (≥ 2 levels) | 6 Participants |
| Binocular Computer Game Treatment Younger Cohort | Change in Diplopia Frequency From Baseline to 4 Weeks (Participant-reported) | Similar frequency (within 1 level) | 79 Participants |
| Binocular Computer Game Treatment Younger Cohort | Change in Diplopia Frequency From Baseline to 4 Weeks (Participant-reported) | Reduced frequency (≥ 2 levels) | 1 Participants |
| Continued Spectacle Correction Younger Cohort | Change in Diplopia Frequency From Baseline to 4 Weeks (Participant-reported) | Reduced frequency (≥ 2 levels) | 2 Participants |
| Continued Spectacle Correction Younger Cohort | Change in Diplopia Frequency From Baseline to 4 Weeks (Participant-reported) | Similar frequency (within 1 level) | 80 Participants |
| Continued Spectacle Correction Younger Cohort | Change in Diplopia Frequency From Baseline to 4 Weeks (Participant-reported) | Increased frequency (≥ 2 levels) | 2 Participants |
Comparison: The exact Wilcoxon rank-sum test was used to compare the change in diplopia frequency levels from baseline to the 4-week visit by treatment group.p-value: 0.44Wilcoxon (Mann-Whitney)
Secondary
Change in Diplopia Frequency From Baseline to 8 Weeks (Parent-reported)
A standardized questionnaire was administered to participants and their parents to assess the presence and frequency of any diplopia since the last study visit. Change in diplopia frequency from baseline to 8 weeks was reported categorically.
Time frame: 8 weeks
Population: As this was a safety outcome, all visit information was recorded, regardless of whether or not it was collected in the analysis window.
| Arm | Measure | Group | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|---|
| Binocular Computer Game Treatment Older Cohort | Change in Diplopia Frequency From Baseline to 8 Weeks (Parent-reported) | Reduced frequency (≥ 2 levels) | 0 Participants |
| Binocular Computer Game Treatment Older Cohort | Change in Diplopia Frequency From Baseline to 8 Weeks (Parent-reported) | Increased frequency (≥ 2 levels) | 0 Participants |
| Binocular Computer Game Treatment Older Cohort | Change in Diplopia Frequency From Baseline to 8 Weeks (Parent-reported) | Similar frequency (within 1 level) | 67 Participants |
| Continued Spectacle Correction Older Cohort | Change in Diplopia Frequency From Baseline to 8 Weeks (Parent-reported) | Similar frequency (within 1 level) | 68 Participants |
| Continued Spectacle Correction Older Cohort | Change in Diplopia Frequency From Baseline to 8 Weeks (Parent-reported) | Increased frequency (≥ 2 levels) | 0 Participants |
| Continued Spectacle Correction Older Cohort | Change in Diplopia Frequency From Baseline to 8 Weeks (Parent-reported) | Reduced frequency (≥ 2 levels) | 0 Participants |
| Binocular Computer Game Treatment Younger Cohort | Change in Diplopia Frequency From Baseline to 8 Weeks (Parent-reported) | Reduced frequency (≥ 2 levels) | 0 Participants |
| Binocular Computer Game Treatment Younger Cohort | Change in Diplopia Frequency From Baseline to 8 Weeks (Parent-reported) | Increased frequency (≥ 2 levels) | 0 Participants |
| Binocular Computer Game Treatment Younger Cohort | Change in Diplopia Frequency From Baseline to 8 Weeks (Parent-reported) | Similar frequency (within 1 level) | 86 Participants |
| Continued Spectacle Correction Younger Cohort | Change in Diplopia Frequency From Baseline to 8 Weeks (Parent-reported) | Similar frequency (within 1 level) | 83 Participants |
| Continued Spectacle Correction Younger Cohort | Change in Diplopia Frequency From Baseline to 8 Weeks (Parent-reported) | Increased frequency (≥ 2 levels) | 0 Participants |
| Continued Spectacle Correction Younger Cohort | Change in Diplopia Frequency From Baseline to 8 Weeks (Parent-reported) | Reduced frequency (≥ 2 levels) | 1 Participants |
Comparison: The exact Wilcoxon rank-sum test was used to compare the change in diplopia frequency levels from baseline to the 8-week visit by treatment group.p-value: >0.99Wilcoxon (Mann-Whitney)
Secondary
Change in Diplopia Frequency From Baseline to 8 Weeks (Participant-reported)
A standardized questionnaire was administered to participants and their parents to assess the presence and frequency of any diplopia since the last study visit. Change in diplopia frequency from baseline to 8 weeks was reported categorically.
Time frame: 8 weeks
Population: As this was a safety outcome, all visit information was recorded, regardless of whether or not it was collected in the analysis window. There was 1 missing participant-reported diplopia frequency at baseline in the Binocular Younger cohort.
| Arm | Measure | Group | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|---|
| Binocular Computer Game Treatment Older Cohort | Change in Diplopia Frequency From Baseline to 8 Weeks (Participant-reported) | Increased frequency (≥ 2 levels) | 0 Participants |
| Binocular Computer Game Treatment Older Cohort | Change in Diplopia Frequency From Baseline to 8 Weeks (Participant-reported) | Reduced frequency (≥ 2 levels) | 4 Participants |
| Binocular Computer Game Treatment Older Cohort | Change in Diplopia Frequency From Baseline to 8 Weeks (Participant-reported) | Similar frequency (within 1 level) | 64 Participants |
| Continued Spectacle Correction Older Cohort | Change in Diplopia Frequency From Baseline to 8 Weeks (Participant-reported) | Increased frequency (≥ 2 levels) | 1 Participants |
| Continued Spectacle Correction Older Cohort | Change in Diplopia Frequency From Baseline to 8 Weeks (Participant-reported) | Reduced frequency (≥ 2 levels) | 1 Participants |
| Continued Spectacle Correction Older Cohort | Change in Diplopia Frequency From Baseline to 8 Weeks (Participant-reported) | Similar frequency (within 1 level) | 66 Participants |
| Binocular Computer Game Treatment Younger Cohort | Change in Diplopia Frequency From Baseline to 8 Weeks (Participant-reported) | Similar frequency (within 1 level) | 82 Participants |
| Binocular Computer Game Treatment Younger Cohort | Change in Diplopia Frequency From Baseline to 8 Weeks (Participant-reported) | Increased frequency (≥ 2 levels) | 2 Participants |
| Binocular Computer Game Treatment Younger Cohort | Change in Diplopia Frequency From Baseline to 8 Weeks (Participant-reported) | Reduced frequency (≥ 2 levels) | 1 Participants |
| Continued Spectacle Correction Younger Cohort | Change in Diplopia Frequency From Baseline to 8 Weeks (Participant-reported) | Increased frequency (≥ 2 levels) | 1 Participants |
| Continued Spectacle Correction Younger Cohort | Change in Diplopia Frequency From Baseline to 8 Weeks (Participant-reported) | Reduced frequency (≥ 2 levels) | 3 Participants |
| Continued Spectacle Correction Younger Cohort | Change in Diplopia Frequency From Baseline to 8 Weeks (Participant-reported) | Similar frequency (within 1 level) | 80 Participants |
Comparison: The exact Wilcoxon rank-sum test was used to compare the change in diplopia frequency levels from baseline to the 8-week visit by treatment group.p-value: >0.99Wilcoxon (Mann-Whitney)
Secondary
Distribution of Change in Adverse Symptom Frequency (Symptom Survey) From Baseline to 4 Weeks
The child and parent(s) will complete a 5-item symptom survey regarding the presence of various ocular symptoms within the past 2 weeks at enrollment and at each visit. The distribution of scores on each symptom survey item will be described for the enrollment exam and the 4-week exam for each treatment group. The distribution of change in scores on each symptom survey item will also be described for each treatment group.
Time frame: 4 weeks
Population: There were 3 participants in the control treatment group with responses of 'Not wearing spectacles'. These participants were excluded from the tabulations in the table and any analyses specific to these Symptom Survey items.
| Arm | Measure | Group | Category | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|---|---|
| Binocular Computer Game Treatment Older Cohort | Distribution of Change in Adverse Symptom Frequency (Symptom Survey) From Baseline to 4 Weeks | Take Off Spectacles | Similar frequency (within 1 level) | 64 Participants |
| Binocular Computer Game Treatment Older Cohort | Distribution of Change in Adverse Symptom Frequency (Symptom Survey) From Baseline to 4 Weeks | Headache | Similar frequency (within 1 level) | 60 Participants |
| Binocular Computer Game Treatment Older Cohort | Distribution of Change in Adverse Symptom Frequency (Symptom Survey) From Baseline to 4 Weeks | Headache | Increased frequency (≥ 2 levels) | 2 Participants |
| Binocular Computer Game Treatment Older Cohort | Distribution of Change in Adverse Symptom Frequency (Symptom Survey) From Baseline to 4 Weeks | Eyestrain | Similar frequency (within 1 level) | 61 Participants |
| Binocular Computer Game Treatment Older Cohort | Distribution of Change in Adverse Symptom Frequency (Symptom Survey) From Baseline to 4 Weeks | Take Off Spectacles | Increased frequency (≥ 2 levels) | 0 Participants |
| Binocular Computer Game Treatment Older Cohort | Distribution of Change in Adverse Symptom Frequency (Symptom Survey) From Baseline to 4 Weeks | Eyestrain | Reduced frequency (≥ 2 levels) | 7 Participants |
| Binocular Computer Game Treatment Older Cohort | Distribution of Change in Adverse Symptom Frequency (Symptom Survey) From Baseline to 4 Weeks | Blurred Vision | Similar frequency (within 1 level) | 62 Participants |
| Binocular Computer Game Treatment Older Cohort | Distribution of Change in Adverse Symptom Frequency (Symptom Survey) From Baseline to 4 Weeks | Blurred Vision | Increased frequency (≥ 2 levels) | 1 Participants |
| Binocular Computer Game Treatment Older Cohort | Distribution of Change in Adverse Symptom Frequency (Symptom Survey) From Baseline to 4 Weeks | Look Over Spectacles | Reduced frequency (≥ 2 levels) | 7 Participants |
| Binocular Computer Game Treatment Older Cohort | Distribution of Change in Adverse Symptom Frequency (Symptom Survey) From Baseline to 4 Weeks | Look Over Spectacles | Similar frequency (within 1 level) | 60 Participants |
| Binocular Computer Game Treatment Older Cohort | Distribution of Change in Adverse Symptom Frequency (Symptom Survey) From Baseline to 4 Weeks | Blurred Vision | Reduced frequency (≥ 2 levels) | 6 Participants |
| Binocular Computer Game Treatment Older Cohort | Distribution of Change in Adverse Symptom Frequency (Symptom Survey) From Baseline to 4 Weeks | Take Off Spectacles | Reduced frequency (≥ 2 levels) | 5 Participants |
| Binocular Computer Game Treatment Older Cohort | Distribution of Change in Adverse Symptom Frequency (Symptom Survey) From Baseline to 4 Weeks | Look Over Spectacles | Increased frequency (≥ 2 levels) | 2 Participants |
| Binocular Computer Game Treatment Older Cohort | Distribution of Change in Adverse Symptom Frequency (Symptom Survey) From Baseline to 4 Weeks | Headache | Reduced frequency (≥ 2 levels) | 7 Participants |
| Binocular Computer Game Treatment Older Cohort | Distribution of Change in Adverse Symptom Frequency (Symptom Survey) From Baseline to 4 Weeks | Eyestrain | Increased frequency (≥ 2 levels) | 1 Participants |
| Continued Spectacle Correction Older Cohort | Distribution of Change in Adverse Symptom Frequency (Symptom Survey) From Baseline to 4 Weeks | Eyestrain | Reduced frequency (≥ 2 levels) | 12 Participants |
| Continued Spectacle Correction Older Cohort | Distribution of Change in Adverse Symptom Frequency (Symptom Survey) From Baseline to 4 Weeks | Blurred Vision | Increased frequency (≥ 2 levels) | 1 Participants |
| Continued Spectacle Correction Older Cohort | Distribution of Change in Adverse Symptom Frequency (Symptom Survey) From Baseline to 4 Weeks | Blurred Vision | Similar frequency (within 1 level) | 59 Participants |
| Continued Spectacle Correction Older Cohort | Distribution of Change in Adverse Symptom Frequency (Symptom Survey) From Baseline to 4 Weeks | Blurred Vision | Reduced frequency (≥ 2 levels) | 7 Participants |
| Continued Spectacle Correction Older Cohort | Distribution of Change in Adverse Symptom Frequency (Symptom Survey) From Baseline to 4 Weeks | Eyestrain | Increased frequency (≥ 2 levels) | 3 Participants |
| Continued Spectacle Correction Older Cohort | Distribution of Change in Adverse Symptom Frequency (Symptom Survey) From Baseline to 4 Weeks | Eyestrain | Similar frequency (within 1 level) | 52 Participants |
| Continued Spectacle Correction Older Cohort | Distribution of Change in Adverse Symptom Frequency (Symptom Survey) From Baseline to 4 Weeks | Headache | Increased frequency (≥ 2 levels) | 2 Participants |
| Continued Spectacle Correction Older Cohort | Distribution of Change in Adverse Symptom Frequency (Symptom Survey) From Baseline to 4 Weeks | Headache | Similar frequency (within 1 level) | 58 Participants |
| Continued Spectacle Correction Older Cohort | Distribution of Change in Adverse Symptom Frequency (Symptom Survey) From Baseline to 4 Weeks | Headache | Reduced frequency (≥ 2 levels) | 7 Participants |
| Continued Spectacle Correction Older Cohort | Distribution of Change in Adverse Symptom Frequency (Symptom Survey) From Baseline to 4 Weeks | Look Over Spectacles | Increased frequency (≥ 2 levels) | 5 Participants |
| Continued Spectacle Correction Older Cohort | Distribution of Change in Adverse Symptom Frequency (Symptom Survey) From Baseline to 4 Weeks | Look Over Spectacles | Similar frequency (within 1 level) | 46 Participants |
| Continued Spectacle Correction Older Cohort | Distribution of Change in Adverse Symptom Frequency (Symptom Survey) From Baseline to 4 Weeks | Look Over Spectacles | Reduced frequency (≥ 2 levels) | 13 Participants |
| Continued Spectacle Correction Older Cohort | Distribution of Change in Adverse Symptom Frequency (Symptom Survey) From Baseline to 4 Weeks | Take Off Spectacles | Increased frequency (≥ 2 levels) | 0 Participants |
| Continued Spectacle Correction Older Cohort | Distribution of Change in Adverse Symptom Frequency (Symptom Survey) From Baseline to 4 Weeks | Take Off Spectacles | Similar frequency (within 1 level) | 54 Participants |
| Continued Spectacle Correction Older Cohort | Distribution of Change in Adverse Symptom Frequency (Symptom Survey) From Baseline to 4 Weeks | Take Off Spectacles | Reduced frequency (≥ 2 levels) | 10 Participants |
| Binocular Computer Game Treatment Younger Cohort | Distribution of Change in Adverse Symptom Frequency (Symptom Survey) From Baseline to 4 Weeks | Eyestrain | Increased frequency (≥ 2 levels) | 9 Participants |
| Binocular Computer Game Treatment Younger Cohort | Distribution of Change in Adverse Symptom Frequency (Symptom Survey) From Baseline to 4 Weeks | Blurred Vision | Increased frequency (≥ 2 levels) | 4 Participants |
| Binocular Computer Game Treatment Younger Cohort | Distribution of Change in Adverse Symptom Frequency (Symptom Survey) From Baseline to 4 Weeks | Headache | Similar frequency (within 1 level) | 76 Participants |
| Binocular Computer Game Treatment Younger Cohort | Distribution of Change in Adverse Symptom Frequency (Symptom Survey) From Baseline to 4 Weeks | Take Off Spectacles | Reduced frequency (≥ 2 levels) | 9 Participants |
| Binocular Computer Game Treatment Younger Cohort | Distribution of Change in Adverse Symptom Frequency (Symptom Survey) From Baseline to 4 Weeks | Headache | Reduced frequency (≥ 2 levels) | 5 Participants |
| Binocular Computer Game Treatment Younger Cohort | Distribution of Change in Adverse Symptom Frequency (Symptom Survey) From Baseline to 4 Weeks | Blurred Vision | Reduced frequency (≥ 2 levels) | 11 Participants |
| Binocular Computer Game Treatment Younger Cohort | Distribution of Change in Adverse Symptom Frequency (Symptom Survey) From Baseline to 4 Weeks | Take Off Spectacles | Similar frequency (within 1 level) | 78 Participants |
| Binocular Computer Game Treatment Younger Cohort | Distribution of Change in Adverse Symptom Frequency (Symptom Survey) From Baseline to 4 Weeks | Look Over Spectacles | Similar frequency (within 1 level) | 72 Participants |
| Binocular Computer Game Treatment Younger Cohort | Distribution of Change in Adverse Symptom Frequency (Symptom Survey) From Baseline to 4 Weeks | Blurred Vision | Similar frequency (within 1 level) | 73 Participants |
| Binocular Computer Game Treatment Younger Cohort | Distribution of Change in Adverse Symptom Frequency (Symptom Survey) From Baseline to 4 Weeks | Look Over Spectacles | Reduced frequency (≥ 2 levels) | 12 Participants |
| Binocular Computer Game Treatment Younger Cohort | Distribution of Change in Adverse Symptom Frequency (Symptom Survey) From Baseline to 4 Weeks | Take Off Spectacles | Increased frequency (≥ 2 levels) | 1 Participants |
| Binocular Computer Game Treatment Younger Cohort | Distribution of Change in Adverse Symptom Frequency (Symptom Survey) From Baseline to 4 Weeks | Eyestrain | Similar frequency (within 1 level) | 73 Participants |
| Binocular Computer Game Treatment Younger Cohort | Distribution of Change in Adverse Symptom Frequency (Symptom Survey) From Baseline to 4 Weeks | Look Over Spectacles | Increased frequency (≥ 2 levels) | 4 Participants |
| Binocular Computer Game Treatment Younger Cohort | Distribution of Change in Adverse Symptom Frequency (Symptom Survey) From Baseline to 4 Weeks | Eyestrain | Reduced frequency (≥ 2 levels) | 6 Participants |
| Binocular Computer Game Treatment Younger Cohort | Distribution of Change in Adverse Symptom Frequency (Symptom Survey) From Baseline to 4 Weeks | Headache | Increased frequency (≥ 2 levels) | 7 Participants |
| Continued Spectacle Correction Younger Cohort | Distribution of Change in Adverse Symptom Frequency (Symptom Survey) From Baseline to 4 Weeks | Take Off Spectacles | Increased frequency (≥ 2 levels) | 0 Participants |
| Continued Spectacle Correction Younger Cohort | Distribution of Change in Adverse Symptom Frequency (Symptom Survey) From Baseline to 4 Weeks | Look Over Spectacles | Reduced frequency (≥ 2 levels) | 8 Participants |
| Continued Spectacle Correction Younger Cohort | Distribution of Change in Adverse Symptom Frequency (Symptom Survey) From Baseline to 4 Weeks | Headache | Increased frequency (≥ 2 levels) | 0 Participants |
| Continued Spectacle Correction Younger Cohort | Distribution of Change in Adverse Symptom Frequency (Symptom Survey) From Baseline to 4 Weeks | Headache | Similar frequency (within 1 level) | 72 Participants |
| Continued Spectacle Correction Younger Cohort | Distribution of Change in Adverse Symptom Frequency (Symptom Survey) From Baseline to 4 Weeks | Blurred Vision | Reduced frequency (≥ 2 levels) | 11 Participants |
| Continued Spectacle Correction Younger Cohort | Distribution of Change in Adverse Symptom Frequency (Symptom Survey) From Baseline to 4 Weeks | Blurred Vision | Increased frequency (≥ 2 levels) | 0 Participants |
| Continued Spectacle Correction Younger Cohort | Distribution of Change in Adverse Symptom Frequency (Symptom Survey) From Baseline to 4 Weeks | Take Off Spectacles | Reduced frequency (≥ 2 levels) | 3 Participants |
| Continued Spectacle Correction Younger Cohort | Distribution of Change in Adverse Symptom Frequency (Symptom Survey) From Baseline to 4 Weeks | Headache | Reduced frequency (≥ 2 levels) | 11 Participants |
| Continued Spectacle Correction Younger Cohort | Distribution of Change in Adverse Symptom Frequency (Symptom Survey) From Baseline to 4 Weeks | Eyestrain | Reduced frequency (≥ 2 levels) | 10 Participants |
| Continued Spectacle Correction Younger Cohort | Distribution of Change in Adverse Symptom Frequency (Symptom Survey) From Baseline to 4 Weeks | Eyestrain | Similar frequency (within 1 level) | 73 Participants |
| Continued Spectacle Correction Younger Cohort | Distribution of Change in Adverse Symptom Frequency (Symptom Survey) From Baseline to 4 Weeks | Look Over Spectacles | Increased frequency (≥ 2 levels) | 2 Participants |
| Continued Spectacle Correction Younger Cohort | Distribution of Change in Adverse Symptom Frequency (Symptom Survey) From Baseline to 4 Weeks | Blurred Vision | Similar frequency (within 1 level) | 72 Participants |
| Continued Spectacle Correction Younger Cohort | Distribution of Change in Adverse Symptom Frequency (Symptom Survey) From Baseline to 4 Weeks | Take Off Spectacles | Similar frequency (within 1 level) | 80 Participants |
| Continued Spectacle Correction Younger Cohort | Distribution of Change in Adverse Symptom Frequency (Symptom Survey) From Baseline to 4 Weeks | Eyestrain | Increased frequency (≥ 2 levels) | 0 Participants |
| Continued Spectacle Correction Younger Cohort | Distribution of Change in Adverse Symptom Frequency (Symptom Survey) From Baseline to 4 Weeks | Look Over Spectacles | Similar frequency (within 1 level) | 73 Participants |
Comparison: For each Symptom Survey item, the exact Wilcoxon rank-sum test was used to compare the change in symptom frequency level from baseline to the 4-week visit by treatment group.p-value: 0.07Wilcoxon (Mann-Whitney)
Secondary
Distribution of Change in Adverse Symptom Frequency (Symptom Survey) From Baseline to 8 Weeks
The child and parent(s) will complete a 5-item symptom survey regarding the presence of various ocular symptoms within the past 2 weeks at enrollment and at each visit. The distribution of scores on each symptom survey item will be described for the enrollment exam and the 8-week exam for each treatment group. The distribution of change in scores on each symptom survey item will also be described for each treatment group.
Time frame: 8 weeks
Population: There were 3 participants in the control treatment group with responses of 'Not wearing spectacles'. These participants were excluded from the tabulations in the table and any analyses specific to these Symptom Survey items. One participant in the binocular treatment group did not have a completed Symptom Survey at the 8-week visit.
| Arm | Measure | Group | Category | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|---|---|
| Binocular Computer Game Treatment Older Cohort | Distribution of Change in Adverse Symptom Frequency (Symptom Survey) From Baseline to 8 Weeks | Blurred Vision | Increased frequency (≥ 2 levels) | 1 Participants |
| Binocular Computer Game Treatment Older Cohort | Distribution of Change in Adverse Symptom Frequency (Symptom Survey) From Baseline to 8 Weeks | Look Over Spectacles | Reduced frequency (≥ 2 levels) | 10 Participants |
| Binocular Computer Game Treatment Older Cohort | Distribution of Change in Adverse Symptom Frequency (Symptom Survey) From Baseline to 8 Weeks | Headache | Reduced frequency (≥ 2 levels) | 5 Participants |
| Binocular Computer Game Treatment Older Cohort | Distribution of Change in Adverse Symptom Frequency (Symptom Survey) From Baseline to 8 Weeks | Blurred Vision | Reduced frequency (≥ 2 levels) | 5 Participants |
| Binocular Computer Game Treatment Older Cohort | Distribution of Change in Adverse Symptom Frequency (Symptom Survey) From Baseline to 8 Weeks | Look Over Spectacles | Increased frequency (≥ 2 levels) | 3 Participants |
| Binocular Computer Game Treatment Older Cohort | Distribution of Change in Adverse Symptom Frequency (Symptom Survey) From Baseline to 8 Weeks | Look Over Spectacles | Similar frequency (within 1 level) | 54 Participants |
| Binocular Computer Game Treatment Older Cohort | Distribution of Change in Adverse Symptom Frequency (Symptom Survey) From Baseline to 8 Weeks | Eyestrain | Increased frequency (≥ 2 levels) | 1 Participants |
| Binocular Computer Game Treatment Older Cohort | Distribution of Change in Adverse Symptom Frequency (Symptom Survey) From Baseline to 8 Weeks | Blurred Vision | Similar frequency (within 1 level) | 61 Participants |
| Binocular Computer Game Treatment Older Cohort | Distribution of Change in Adverse Symptom Frequency (Symptom Survey) From Baseline to 8 Weeks | Take Off Spectacles | Similar frequency (within 1 level) | 62 Participants |
| Binocular Computer Game Treatment Older Cohort | Distribution of Change in Adverse Symptom Frequency (Symptom Survey) From Baseline to 8 Weeks | Eyestrain | Similar frequency (within 1 level) | 60 Participants |
| Binocular Computer Game Treatment Older Cohort | Distribution of Change in Adverse Symptom Frequency (Symptom Survey) From Baseline to 8 Weeks | Eyestrain | Reduced frequency (≥ 2 levels) | 6 Participants |
| Binocular Computer Game Treatment Older Cohort | Distribution of Change in Adverse Symptom Frequency (Symptom Survey) From Baseline to 8 Weeks | Take Off Spectacles | Increased frequency (≥ 2 levels) | 0 Participants |
| Binocular Computer Game Treatment Older Cohort | Distribution of Change in Adverse Symptom Frequency (Symptom Survey) From Baseline to 8 Weeks | Headache | Increased frequency (≥ 2 levels) | 2 Participants |
| Binocular Computer Game Treatment Older Cohort | Distribution of Change in Adverse Symptom Frequency (Symptom Survey) From Baseline to 8 Weeks | Take Off Spectacles | Reduced frequency (≥ 2 levels) | 5 Participants |
| Binocular Computer Game Treatment Older Cohort | Distribution of Change in Adverse Symptom Frequency (Symptom Survey) From Baseline to 8 Weeks | Headache | Similar frequency (within 1 level) | 60 Participants |
| Continued Spectacle Correction Older Cohort | Distribution of Change in Adverse Symptom Frequency (Symptom Survey) From Baseline to 8 Weeks | Headache | Similar frequency (within 1 level) | 59 Participants |
| Continued Spectacle Correction Older Cohort | Distribution of Change in Adverse Symptom Frequency (Symptom Survey) From Baseline to 8 Weeks | Look Over Spectacles | Reduced frequency (≥ 2 levels) | 15 Participants |
| Continued Spectacle Correction Older Cohort | Distribution of Change in Adverse Symptom Frequency (Symptom Survey) From Baseline to 8 Weeks | Eyestrain | Similar frequency (within 1 level) | 55 Participants |
| Continued Spectacle Correction Older Cohort | Distribution of Change in Adverse Symptom Frequency (Symptom Survey) From Baseline to 8 Weeks | Headache | Reduced frequency (≥ 2 levels) | 9 Participants |
| Continued Spectacle Correction Older Cohort | Distribution of Change in Adverse Symptom Frequency (Symptom Survey) From Baseline to 8 Weeks | Blurred Vision | Similar frequency (within 1 level) | 57 Participants |
| Continued Spectacle Correction Older Cohort | Distribution of Change in Adverse Symptom Frequency (Symptom Survey) From Baseline to 8 Weeks | Look Over Spectacles | Similar frequency (within 1 level) | 50 Participants |
| Continued Spectacle Correction Older Cohort | Distribution of Change in Adverse Symptom Frequency (Symptom Survey) From Baseline to 8 Weeks | Take Off Spectacles | Increased frequency (≥ 2 levels) | 0 Participants |
| Continued Spectacle Correction Older Cohort | Distribution of Change in Adverse Symptom Frequency (Symptom Survey) From Baseline to 8 Weeks | Look Over Spectacles | Increased frequency (≥ 2 levels) | 0 Participants |
| Continued Spectacle Correction Older Cohort | Distribution of Change in Adverse Symptom Frequency (Symptom Survey) From Baseline to 8 Weeks | Blurred Vision | Reduced frequency (≥ 2 levels) | 9 Participants |
| Continued Spectacle Correction Older Cohort | Distribution of Change in Adverse Symptom Frequency (Symptom Survey) From Baseline to 8 Weeks | Headache | Increased frequency (≥ 2 levels) | 0 Participants |
| Continued Spectacle Correction Older Cohort | Distribution of Change in Adverse Symptom Frequency (Symptom Survey) From Baseline to 8 Weeks | Take Off Spectacles | Reduced frequency (≥ 2 levels) | 10 Participants |
| Continued Spectacle Correction Older Cohort | Distribution of Change in Adverse Symptom Frequency (Symptom Survey) From Baseline to 8 Weeks | Take Off Spectacles | Similar frequency (within 1 level) | 55 Participants |
| Continued Spectacle Correction Older Cohort | Distribution of Change in Adverse Symptom Frequency (Symptom Survey) From Baseline to 8 Weeks | Eyestrain | Reduced frequency (≥ 2 levels) | 12 Participants |
| Continued Spectacle Correction Older Cohort | Distribution of Change in Adverse Symptom Frequency (Symptom Survey) From Baseline to 8 Weeks | Eyestrain | Increased frequency (≥ 2 levels) | 1 Participants |
| Continued Spectacle Correction Older Cohort | Distribution of Change in Adverse Symptom Frequency (Symptom Survey) From Baseline to 8 Weeks | Blurred Vision | Increased frequency (≥ 2 levels) | 2 Participants |
| Binocular Computer Game Treatment Younger Cohort | Distribution of Change in Adverse Symptom Frequency (Symptom Survey) From Baseline to 8 Weeks | Headache | Similar frequency (within 1 level) | 76 Participants |
| Binocular Computer Game Treatment Younger Cohort | Distribution of Change in Adverse Symptom Frequency (Symptom Survey) From Baseline to 8 Weeks | Blurred Vision | Increased frequency (≥ 2 levels) | 4 Participants |
| Binocular Computer Game Treatment Younger Cohort | Distribution of Change in Adverse Symptom Frequency (Symptom Survey) From Baseline to 8 Weeks | Blurred Vision | Similar frequency (within 1 level) | 67 Participants |
| Binocular Computer Game Treatment Younger Cohort | Distribution of Change in Adverse Symptom Frequency (Symptom Survey) From Baseline to 8 Weeks | Blurred Vision | Reduced frequency (≥ 2 levels) | 15 Participants |
| Binocular Computer Game Treatment Younger Cohort | Distribution of Change in Adverse Symptom Frequency (Symptom Survey) From Baseline to 8 Weeks | Eyestrain | Increased frequency (≥ 2 levels) | 5 Participants |
| Binocular Computer Game Treatment Younger Cohort | Distribution of Change in Adverse Symptom Frequency (Symptom Survey) From Baseline to 8 Weeks | Eyestrain | Similar frequency (within 1 level) | 75 Participants |
| Binocular Computer Game Treatment Younger Cohort | Distribution of Change in Adverse Symptom Frequency (Symptom Survey) From Baseline to 8 Weeks | Eyestrain | Reduced frequency (≥ 2 levels) | 6 Participants |
| Binocular Computer Game Treatment Younger Cohort | Distribution of Change in Adverse Symptom Frequency (Symptom Survey) From Baseline to 8 Weeks | Headache | Increased frequency (≥ 2 levels) | 5 Participants |
| Binocular Computer Game Treatment Younger Cohort | Distribution of Change in Adverse Symptom Frequency (Symptom Survey) From Baseline to 8 Weeks | Headache | Reduced frequency (≥ 2 levels) | 5 Participants |
| Binocular Computer Game Treatment Younger Cohort | Distribution of Change in Adverse Symptom Frequency (Symptom Survey) From Baseline to 8 Weeks | Look Over Spectacles | Increased frequency (≥ 2 levels) | 6 Participants |
| Binocular Computer Game Treatment Younger Cohort | Distribution of Change in Adverse Symptom Frequency (Symptom Survey) From Baseline to 8 Weeks | Look Over Spectacles | Similar frequency (within 1 level) | 70 Participants |
| Binocular Computer Game Treatment Younger Cohort | Distribution of Change in Adverse Symptom Frequency (Symptom Survey) From Baseline to 8 Weeks | Look Over Spectacles | Reduced frequency (≥ 2 levels) | 10 Participants |
| Binocular Computer Game Treatment Younger Cohort | Distribution of Change in Adverse Symptom Frequency (Symptom Survey) From Baseline to 8 Weeks | Take Off Spectacles | Increased frequency (≥ 2 levels) | 0 Participants |
| Binocular Computer Game Treatment Younger Cohort | Distribution of Change in Adverse Symptom Frequency (Symptom Survey) From Baseline to 8 Weeks | Take Off Spectacles | Similar frequency (within 1 level) | 76 Participants |
| Binocular Computer Game Treatment Younger Cohort | Distribution of Change in Adverse Symptom Frequency (Symptom Survey) From Baseline to 8 Weeks | Take Off Spectacles | Reduced frequency (≥ 2 levels) | 10 Participants |
| Continued Spectacle Correction Younger Cohort | Distribution of Change in Adverse Symptom Frequency (Symptom Survey) From Baseline to 8 Weeks | Headache | Increased frequency (≥ 2 levels) | 0 Participants |
| Continued Spectacle Correction Younger Cohort | Distribution of Change in Adverse Symptom Frequency (Symptom Survey) From Baseline to 8 Weeks | Blurred Vision | Similar frequency (within 1 level) | 71 Participants |
| Continued Spectacle Correction Younger Cohort | Distribution of Change in Adverse Symptom Frequency (Symptom Survey) From Baseline to 8 Weeks | Look Over Spectacles | Reduced frequency (≥ 2 levels) | 5 Participants |
| Continued Spectacle Correction Younger Cohort | Distribution of Change in Adverse Symptom Frequency (Symptom Survey) From Baseline to 8 Weeks | Eyestrain | Reduced frequency (≥ 2 levels) | 11 Participants |
| Continued Spectacle Correction Younger Cohort | Distribution of Change in Adverse Symptom Frequency (Symptom Survey) From Baseline to 8 Weeks | Eyestrain | Similar frequency (within 1 level) | 72 Participants |
| Continued Spectacle Correction Younger Cohort | Distribution of Change in Adverse Symptom Frequency (Symptom Survey) From Baseline to 8 Weeks | Blurred Vision | Increased frequency (≥ 2 levels) | 2 Participants |
| Continued Spectacle Correction Younger Cohort | Distribution of Change in Adverse Symptom Frequency (Symptom Survey) From Baseline to 8 Weeks | Take Off Spectacles | Increased frequency (≥ 2 levels) | 2 Participants |
| Continued Spectacle Correction Younger Cohort | Distribution of Change in Adverse Symptom Frequency (Symptom Survey) From Baseline to 8 Weeks | Eyestrain | Increased frequency (≥ 2 levels) | 1 Participants |
| Continued Spectacle Correction Younger Cohort | Distribution of Change in Adverse Symptom Frequency (Symptom Survey) From Baseline to 8 Weeks | Blurred Vision | Reduced frequency (≥ 2 levels) | 11 Participants |
| Continued Spectacle Correction Younger Cohort | Distribution of Change in Adverse Symptom Frequency (Symptom Survey) From Baseline to 8 Weeks | Take Off Spectacles | Reduced frequency (≥ 2 levels) | 5 Participants |
| Continued Spectacle Correction Younger Cohort | Distribution of Change in Adverse Symptom Frequency (Symptom Survey) From Baseline to 8 Weeks | Look Over Spectacles | Increased frequency (≥ 2 levels) | 3 Participants |
| Continued Spectacle Correction Younger Cohort | Distribution of Change in Adverse Symptom Frequency (Symptom Survey) From Baseline to 8 Weeks | Headache | Reduced frequency (≥ 2 levels) | 7 Participants |
| Continued Spectacle Correction Younger Cohort | Distribution of Change in Adverse Symptom Frequency (Symptom Survey) From Baseline to 8 Weeks | Take Off Spectacles | Similar frequency (within 1 level) | 77 Participants |
| Continued Spectacle Correction Younger Cohort | Distribution of Change in Adverse Symptom Frequency (Symptom Survey) From Baseline to 8 Weeks | Look Over Spectacles | Similar frequency (within 1 level) | 76 Participants |
| Continued Spectacle Correction Younger Cohort | Distribution of Change in Adverse Symptom Frequency (Symptom Survey) From Baseline to 8 Weeks | Headache | Similar frequency (within 1 level) | 77 Participants |
Comparison: For each Symptom Survey item, the exact Wilcoxon rank-sum test was used to compare the change in symptom frequency level from baseline to the 8-week visit by treatment group. This was utilized for each item in the survey.p-value: 0.06Wilcoxon (Mann-Whitney)
Secondary
Distribution of Change in Stereoacuity Scores From Baseline
Stereoacuity was tested at near in current refractive correction. Stereoacuity scores (seconds of arc) were calculated based on the Randot Butterfly (scores: 2000, Nil) and Randot Preschool stereoacuity (scores: 800, 400, 200, 100, 60 and 40) test methods. Lower scores indicate better stereoacuity. Results of the Randot Butterfly test were analyzed as 2000 (if correct response). Nil (4000) was defined as (1) an incorrect response on the butterfly in absence of a correct response on the 800 seconds of arc level of the Randot Preschool stereoacuity test or (2) an incorrect response on the 800 seconds of arc level if the butterfly was not attempted. For each visit, stereoacuity scores were ordered and assigned a rank score. Change in stereoacuity was calculated as the difference in ranked score between the enrollment and 8-week stereoacuity scores.
Time frame: 8 weeks
Population: Change was only calculated if data was available at both baseline and 4 week time points. Some baseline data was missing in the younger cohort, leading to the numerical inconsistency.
| Arm | Measure | Group | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|---|
| Binocular Computer Game Treatment Older Cohort | Distribution of Change in Stereoacuity Scores From Baseline | 2 or more levels worse | 6 Participants |
| Binocular Computer Game Treatment Older Cohort | Distribution of Change in Stereoacuity Scores From Baseline | 2 or more levels better | 8 Participants |
| Binocular Computer Game Treatment Older Cohort | Distribution of Change in Stereoacuity Scores From Baseline | Within 1 level | 53 Participants |
| Continued Spectacle Correction Older Cohort | Distribution of Change in Stereoacuity Scores From Baseline | 2 or more levels worse | 3 Participants |
| Continued Spectacle Correction Older Cohort | Distribution of Change in Stereoacuity Scores From Baseline | 2 or more levels better | 14 Participants |
| Continued Spectacle Correction Older Cohort | Distribution of Change in Stereoacuity Scores From Baseline | Within 1 level | 51 Participants |
| Binocular Computer Game Treatment Younger Cohort | Distribution of Change in Stereoacuity Scores From Baseline | Within 1 level | 65 Participants |
| Binocular Computer Game Treatment Younger Cohort | Distribution of Change in Stereoacuity Scores From Baseline | 2 or more levels worse | 8 Participants |
| Binocular Computer Game Treatment Younger Cohort | Distribution of Change in Stereoacuity Scores From Baseline | 2 or more levels better | 12 Participants |
| Continued Spectacle Correction Younger Cohort | Distribution of Change in Stereoacuity Scores From Baseline | 2 or more levels worse | 3 Participants |
| Continued Spectacle Correction Younger Cohort | Distribution of Change in Stereoacuity Scores From Baseline | 2 or more levels better | 15 Participants |
| Continued Spectacle Correction Younger Cohort | Distribution of Change in Stereoacuity Scores From Baseline | Within 1 level | 54 Participants |
p-value: 0.53Wilcoxon (Mann-Whitney)
Secondary
Distribution of Change in Stereoacuity Scores From Baseline
Stereoacuity was tested at near in current refractive correction. Stereoacuity scores (seconds of arc) were calculated based on the Randot Butterfly (scores: 2000, Nil) and Randot Preschool stereoacuity (scores: 800, 400, 200, 100, 60 and 40) test methods. Lower scores indicate better stereoacuity. Results of the Randot Butterfly test were analyzed as 2000 (if correct response). Nil (4000) was defined as (1) an incorrect response on the butterfly in absence of a correct response on the 800 seconds of arc level of the Randot Preschool stereoacuity test or (2) an incorrect response on the 800 seconds of arc level if the butterfly was not attempted. For each visit, stereoacuity scores were ordered and assigned a rank score. Change in stereoacuity was calculated as the difference in ranked score between the enrollment and 4-week stereoacuity scores.
Time frame: 4 weeks
Population: Change was only calculated if data was available at both baseline and 4 week time points. Some baseline data was missing in the younger cohort, leading to the numerical inconsistency.
| Arm | Measure | Category | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|---|
| Binocular Computer Game Treatment Older Cohort | Distribution of Change in Stereoacuity Scores From Baseline | 2 or more levels better | 8 Participants |
| Binocular Computer Game Treatment Older Cohort | Distribution of Change in Stereoacuity Scores From Baseline | 2 or more levels worse | 8 Participants |
| Binocular Computer Game Treatment Older Cohort | Distribution of Change in Stereoacuity Scores From Baseline | Within 1 level | 53 Participants |
| Continued Spectacle Correction Older Cohort | Distribution of Change in Stereoacuity Scores From Baseline | 2 or more levels better | 11 Participants |
| Continued Spectacle Correction Older Cohort | Distribution of Change in Stereoacuity Scores From Baseline | Within 1 level | 50 Participants |
| Continued Spectacle Correction Older Cohort | Distribution of Change in Stereoacuity Scores From Baseline | 2 or more levels worse | 6 Participants |
| Binocular Computer Game Treatment Younger Cohort | Distribution of Change in Stereoacuity Scores From Baseline | 2 or more levels worse | 11 Participants |
| Binocular Computer Game Treatment Younger Cohort | Distribution of Change in Stereoacuity Scores From Baseline | Within 1 level | 56 Participants |
| Binocular Computer Game Treatment Younger Cohort | Distribution of Change in Stereoacuity Scores From Baseline | 2 or more levels better | 11 Participants |
| Continued Spectacle Correction Younger Cohort | Distribution of Change in Stereoacuity Scores From Baseline | Within 1 level | 57 Participants |
| Continued Spectacle Correction Younger Cohort | Distribution of Change in Stereoacuity Scores From Baseline | 2 or more levels better | 8 Participants |
| Continued Spectacle Correction Younger Cohort | Distribution of Change in Stereoacuity Scores From Baseline | 2 or more levels worse | 8 Participants |
p-value: 0.38Wilcoxon (Mann-Whitney)
Secondary
Distribution of Change in Stereoacuity Scores From Baseline (Participants With no History of Strabismus)
Stereoacuity was tested at near in current refractive correction. Stereoacuity scores (seconds of arc) were calculated based on the Randot Butterfly (scores: 2000, Nil) and Randot Preschool stereoacuity (scores: 800, 400, 200, 100, 60 and 40) test methods. Lower scores indicate better stereoacuity. Results of the Randot Butterfly test were analyzed as 2000 (if correct response). Nil (4000) was defined as (1) an incorrect response on the butterfly in absence of a correct response on the 800 seconds of arc level of the Randot Preschool stereoacuity test or (2) an incorrect response on the 800 seconds of arc level if the butterfly was not attempted. For each visit, stereoacuity scores were ordered and assigned a rank score. Change in stereoacuity was calculated as the difference in ranked score between the enrollment and 4-week stereoacuity scores.
Time frame: 8 weeks
Population: Only participants with no history of strabismus are analyzed, as mentioned in the outcome title.
| Arm | Measure | Group | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|---|
| Binocular Computer Game Treatment Older Cohort | Distribution of Change in Stereoacuity Scores From Baseline (Participants With no History of Strabismus) | 2 or more levels worse | 3 Participants |
| Binocular Computer Game Treatment Older Cohort | Distribution of Change in Stereoacuity Scores From Baseline (Participants With no History of Strabismus) | 2 or more levels better | 5 Participants |
| Binocular Computer Game Treatment Older Cohort | Distribution of Change in Stereoacuity Scores From Baseline (Participants With no History of Strabismus) | Within 1 level | 19 Participants |
| Continued Spectacle Correction Older Cohort | Distribution of Change in Stereoacuity Scores From Baseline (Participants With no History of Strabismus) | 2 or more levels worse | 0 Participants |
| Continued Spectacle Correction Older Cohort | Distribution of Change in Stereoacuity Scores From Baseline (Participants With no History of Strabismus) | 2 or more levels better | 7 Participants |
| Continued Spectacle Correction Older Cohort | Distribution of Change in Stereoacuity Scores From Baseline (Participants With no History of Strabismus) | Within 1 level | 31 Participants |
| Binocular Computer Game Treatment Younger Cohort | Distribution of Change in Stereoacuity Scores From Baseline (Participants With no History of Strabismus) | Within 1 level | 44 Participants |
| Binocular Computer Game Treatment Younger Cohort | Distribution of Change in Stereoacuity Scores From Baseline (Participants With no History of Strabismus) | 2 or more levels worse | 5 Participants |
| Binocular Computer Game Treatment Younger Cohort | Distribution of Change in Stereoacuity Scores From Baseline (Participants With no History of Strabismus) | 2 or more levels better | 8 Participants |
| Continued Spectacle Correction Younger Cohort | Distribution of Change in Stereoacuity Scores From Baseline (Participants With no History of Strabismus) | 2 or more levels worse | 4 Participants |
| Continued Spectacle Correction Younger Cohort | Distribution of Change in Stereoacuity Scores From Baseline (Participants With no History of Strabismus) | 2 or more levels better | 13 Participants |
| Continued Spectacle Correction Younger Cohort | Distribution of Change in Stereoacuity Scores From Baseline (Participants With no History of Strabismus) | Within 1 level | 34 Participants |
p-value: 0.74Wilcoxon (Mann-Whitney)
Secondary
Distribution of Change in Stereoacuity Scores From Baseline (Participants With no History of Strabismus)
Stereoacuity was tested at near in current refractive correction. Stereoacuity scores (seconds of arc) were calculated based on the Randot Butterfly (scores: 2000, Nil) and Randot Preschool stereoacuity (scores: 800, 400, 200, 100, 60 and 40) test methods. Lower scores indicate better stereoacuity. Results of the Randot Butterfly test were analyzed as 2000 (if correct response). Nil (4000) was defined as (1) an incorrect response on the butterfly in absence of a correct response on the 800 seconds of arc level of the Randot Preschool stereoacuity test or (2) an incorrect response on the 800 seconds of arc level if the butterfly was not attempted. For each visit, stereoacuity scores were ordered and assigned a rank score. Change in stereoacuity was calculated as the difference in ranked score between the enrollment and 4-week stereoacuity scores.
Time frame: 4 weeks
Population: Only participants with no history of strabismus are analyzed, as mentioned in the outcome title. Change was only calculated if data was available at both baseline and 4 week time points. Some baseline data was missing in the younger cohort, leading to the numerical inconsistency.
| Arm | Measure | Group | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|---|
| Binocular Computer Game Treatment Older Cohort | Distribution of Change in Stereoacuity Scores From Baseline (Participants With no History of Strabismus) | 2 or more levels worse | 5 Participants |
| Binocular Computer Game Treatment Older Cohort | Distribution of Change in Stereoacuity Scores From Baseline (Participants With no History of Strabismus) | 2 or more levels better | 5 Participants |
| Binocular Computer Game Treatment Older Cohort | Distribution of Change in Stereoacuity Scores From Baseline (Participants With no History of Strabismus) | Within 1 level | 17 Participants |
| Continued Spectacle Correction Older Cohort | Distribution of Change in Stereoacuity Scores From Baseline (Participants With no History of Strabismus) | 2 or more levels worse | 2 Participants |
| Continued Spectacle Correction Older Cohort | Distribution of Change in Stereoacuity Scores From Baseline (Participants With no History of Strabismus) | 2 or more levels better | 8 Participants |
| Continued Spectacle Correction Older Cohort | Distribution of Change in Stereoacuity Scores From Baseline (Participants With no History of Strabismus) | Within 1 level | 27 Participants |
| Binocular Computer Game Treatment Younger Cohort | Distribution of Change in Stereoacuity Scores From Baseline (Participants With no History of Strabismus) | Within 1 level | 37 Participants |
| Binocular Computer Game Treatment Younger Cohort | Distribution of Change in Stereoacuity Scores From Baseline (Participants With no History of Strabismus) | 2 or more levels worse | 8 Participants |
| Binocular Computer Game Treatment Younger Cohort | Distribution of Change in Stereoacuity Scores From Baseline (Participants With no History of Strabismus) | 2 or more levels better | 9 Participants |
| Continued Spectacle Correction Younger Cohort | Distribution of Change in Stereoacuity Scores From Baseline (Participants With no History of Strabismus) | 2 or more levels worse | 6 Participants |
| Continued Spectacle Correction Younger Cohort | Distribution of Change in Stereoacuity Scores From Baseline (Participants With no History of Strabismus) | 2 or more levels better | 5 Participants |
| Continued Spectacle Correction Younger Cohort | Distribution of Change in Stereoacuity Scores From Baseline (Participants With no History of Strabismus) | Within 1 level | 34 Participants |
p-value: 0.19Wilcoxon (Mann-Whitney)
Secondary
Distribution of Diplopia Frequency at 4 Weeks (Parent-reported)
The proportion of subjects with each level of diplopia frequency will be reported by treatment group at 4 weeks. A standardized questionnaire was administered to participants and their parents to assess the presence and frequency of any diplopia since the last study visit.
Time frame: 4 weeks
Population: As this was a safety outcome, all visit information was recorded, regardless of whether or not it was collected in the analysis window.
| Arm | Measure | Group | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|---|
| Binocular Computer Game Treatment Older Cohort | Distribution of Diplopia Frequency at 4 Weeks (Parent-reported) | Less than once a week | 3 Participants |
| Binocular Computer Game Treatment Older Cohort | Distribution of Diplopia Frequency at 4 Weeks (Parent-reported) | More than 10 times a day | 0 Participants |
| Binocular Computer Game Treatment Older Cohort | Distribution of Diplopia Frequency at 4 Weeks (Parent-reported) | Up to 10 times a day | 0 Participants |
| Binocular Computer Game Treatment Older Cohort | Distribution of Diplopia Frequency at 4 Weeks (Parent-reported) | All the time | 0 Participants |
| Binocular Computer Game Treatment Older Cohort | Distribution of Diplopia Frequency at 4 Weeks (Parent-reported) | Once a week | 1 Participants |
| Binocular Computer Game Treatment Older Cohort | Distribution of Diplopia Frequency at 4 Weeks (Parent-reported) | Never | 65 Participants |
| Binocular Computer Game Treatment Older Cohort | Distribution of Diplopia Frequency at 4 Weeks (Parent-reported) | Once a day | 0 Participants |
| Continued Spectacle Correction Older Cohort | Distribution of Diplopia Frequency at 4 Weeks (Parent-reported) | Once a day | 0 Participants |
| Continued Spectacle Correction Older Cohort | Distribution of Diplopia Frequency at 4 Weeks (Parent-reported) | More than 10 times a day | 0 Participants |
| Continued Spectacle Correction Older Cohort | Distribution of Diplopia Frequency at 4 Weeks (Parent-reported) | Once a week | 0 Participants |
| Continued Spectacle Correction Older Cohort | Distribution of Diplopia Frequency at 4 Weeks (Parent-reported) | Up to 10 times a day | 0 Participants |
| Continued Spectacle Correction Older Cohort | Distribution of Diplopia Frequency at 4 Weeks (Parent-reported) | All the time | 0 Participants |
| Continued Spectacle Correction Older Cohort | Distribution of Diplopia Frequency at 4 Weeks (Parent-reported) | Less than once a week | 0 Participants |
| Continued Spectacle Correction Older Cohort | Distribution of Diplopia Frequency at 4 Weeks (Parent-reported) | Never | 66 Participants |
| Binocular Computer Game Treatment Younger Cohort | Distribution of Diplopia Frequency at 4 Weeks (Parent-reported) | Once a day | 0 Participants |
| Binocular Computer Game Treatment Younger Cohort | Distribution of Diplopia Frequency at 4 Weeks (Parent-reported) | Never | 87 Participants |
| Binocular Computer Game Treatment Younger Cohort | Distribution of Diplopia Frequency at 4 Weeks (Parent-reported) | Less than once a week | 1 Participants |
| Binocular Computer Game Treatment Younger Cohort | Distribution of Diplopia Frequency at 4 Weeks (Parent-reported) | Once a week | 0 Participants |
| Binocular Computer Game Treatment Younger Cohort | Distribution of Diplopia Frequency at 4 Weeks (Parent-reported) | Up to 10 times a day | 0 Participants |
| Binocular Computer Game Treatment Younger Cohort | Distribution of Diplopia Frequency at 4 Weeks (Parent-reported) | More than 10 times a day | 0 Participants |
| Binocular Computer Game Treatment Younger Cohort | Distribution of Diplopia Frequency at 4 Weeks (Parent-reported) | All the time | 0 Participants |
| Continued Spectacle Correction Younger Cohort | Distribution of Diplopia Frequency at 4 Weeks (Parent-reported) | Once a week | 0 Participants |
| Continued Spectacle Correction Younger Cohort | Distribution of Diplopia Frequency at 4 Weeks (Parent-reported) | All the time | 0 Participants |
| Continued Spectacle Correction Younger Cohort | Distribution of Diplopia Frequency at 4 Weeks (Parent-reported) | More than 10 times a day | 0 Participants |
| Continued Spectacle Correction Younger Cohort | Distribution of Diplopia Frequency at 4 Weeks (Parent-reported) | Less than once a week | 0 Participants |
| Continued Spectacle Correction Younger Cohort | Distribution of Diplopia Frequency at 4 Weeks (Parent-reported) | Never | 83 Participants |
| Continued Spectacle Correction Younger Cohort | Distribution of Diplopia Frequency at 4 Weeks (Parent-reported) | Up to 10 times a day | 0 Participants |
| Continued Spectacle Correction Younger Cohort | Distribution of Diplopia Frequency at 4 Weeks (Parent-reported) | Once a day | 0 Participants |
Comparison: The frequency of diplopia, across categories of diplopia, was compared between the treatment groups using the Cochran-Armitage trend test.p-value: 0.12Cochran-Armitage trend test
Secondary
Distribution of Diplopia Frequency at 4 Weeks (Participant-reported)
The proportion of subjects with each level of diplopia frequency will be reported by treatment group at 4 weeks. A standardized questionnaire was administered to participants and their parents to assess the presence and frequency of any diplopia since the last study visit.
Time frame: 4 weeks
Population: As this was a safety outcome, all visit information was recorded, regardless of whether or not it was collected in the analysis window.
| Arm | Measure | Group | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|---|
| Binocular Computer Game Treatment Older Cohort | Distribution of Diplopia Frequency at 4 Weeks (Participant-reported) | All the time | 0 Participants |
| Binocular Computer Game Treatment Older Cohort | Distribution of Diplopia Frequency at 4 Weeks (Participant-reported) | Once a week | 2 Participants |
| Binocular Computer Game Treatment Older Cohort | Distribution of Diplopia Frequency at 4 Weeks (Participant-reported) | More than 10 times a day | 0 Participants |
| Binocular Computer Game Treatment Older Cohort | Distribution of Diplopia Frequency at 4 Weeks (Participant-reported) | Less than once a week | 1 Participants |
| Binocular Computer Game Treatment Older Cohort | Distribution of Diplopia Frequency at 4 Weeks (Participant-reported) | Up to 10 times a day | 2 Participants |
| Binocular Computer Game Treatment Older Cohort | Distribution of Diplopia Frequency at 4 Weeks (Participant-reported) | Once a day | 2 Participants |
| Binocular Computer Game Treatment Older Cohort | Distribution of Diplopia Frequency at 4 Weeks (Participant-reported) | Never | 62 Participants |
| Continued Spectacle Correction Older Cohort | Distribution of Diplopia Frequency at 4 Weeks (Participant-reported) | Once a day | 1 Participants |
| Continued Spectacle Correction Older Cohort | Distribution of Diplopia Frequency at 4 Weeks (Participant-reported) | Up to 10 times a day | 0 Participants |
| Continued Spectacle Correction Older Cohort | Distribution of Diplopia Frequency at 4 Weeks (Participant-reported) | Less than once a week | 0 Participants |
| Continued Spectacle Correction Older Cohort | Distribution of Diplopia Frequency at 4 Weeks (Participant-reported) | Once a week | 2 Participants |
| Continued Spectacle Correction Older Cohort | Distribution of Diplopia Frequency at 4 Weeks (Participant-reported) | Never | 64 Participants |
| Continued Spectacle Correction Older Cohort | Distribution of Diplopia Frequency at 4 Weeks (Participant-reported) | More than 10 times a day | 0 Participants |
| Continued Spectacle Correction Older Cohort | Distribution of Diplopia Frequency at 4 Weeks (Participant-reported) | All the time | 0 Participants |
| Binocular Computer Game Treatment Younger Cohort | Distribution of Diplopia Frequency at 4 Weeks (Participant-reported) | Never | 78 Participants |
| Binocular Computer Game Treatment Younger Cohort | Distribution of Diplopia Frequency at 4 Weeks (Participant-reported) | Less than once a week | 2 Participants |
| Binocular Computer Game Treatment Younger Cohort | Distribution of Diplopia Frequency at 4 Weeks (Participant-reported) | Once a week | 4 Participants |
| Binocular Computer Game Treatment Younger Cohort | Distribution of Diplopia Frequency at 4 Weeks (Participant-reported) | Once a day | 3 Participants |
| Binocular Computer Game Treatment Younger Cohort | Distribution of Diplopia Frequency at 4 Weeks (Participant-reported) | Up to 10 times a day | 0 Participants |
| Binocular Computer Game Treatment Younger Cohort | Distribution of Diplopia Frequency at 4 Weeks (Participant-reported) | More than 10 times a day | 0 Participants |
| Binocular Computer Game Treatment Younger Cohort | Distribution of Diplopia Frequency at 4 Weeks (Participant-reported) | All the time | 0 Participants |
| Continued Spectacle Correction Younger Cohort | Distribution of Diplopia Frequency at 4 Weeks (Participant-reported) | Once a week | 0 Participants |
| Continued Spectacle Correction Younger Cohort | Distribution of Diplopia Frequency at 4 Weeks (Participant-reported) | All the time | 0 Participants |
| Continued Spectacle Correction Younger Cohort | Distribution of Diplopia Frequency at 4 Weeks (Participant-reported) | More than 10 times a day | 0 Participants |
| Continued Spectacle Correction Younger Cohort | Distribution of Diplopia Frequency at 4 Weeks (Participant-reported) | Less than once a week | 2 Participants |
| Continued Spectacle Correction Younger Cohort | Distribution of Diplopia Frequency at 4 Weeks (Participant-reported) | Never | 79 Participants |
| Continued Spectacle Correction Younger Cohort | Distribution of Diplopia Frequency at 4 Weeks (Participant-reported) | Up to 10 times a day | 0 Participants |
| Continued Spectacle Correction Younger Cohort | Distribution of Diplopia Frequency at 4 Weeks (Participant-reported) | Once a day | 3 Participants |
Comparison: The frequency of diplopia, across categories of diplopia, was compared between the treatment groups using the Cochran-Armitage trend test.p-value: 0.2Cochran-Armitage trend test
Secondary
Distribution of Diplopia Frequency at 8 Weeks (Parent-reported)
The proportion of subjects with each level of diplopia frequency will be reported by treatment group at 8 weeks. A standardized questionnaire was administered to participants and their parents to assess the presence and frequency of any diplopia since the last study visit.
Time frame: 8 weeks
Population: As this was a safety outcome, all visit information was recorded, regardless of whether or not it was collected in the analysis window.
| Arm | Measure | Group | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|---|
| Binocular Computer Game Treatment Older Cohort | Distribution of Diplopia Frequency at 8 Weeks (Parent-reported) | Never | 66 Participants |
| Binocular Computer Game Treatment Older Cohort | Distribution of Diplopia Frequency at 8 Weeks (Parent-reported) | More than 10 times a day | 0 Participants |
| Binocular Computer Game Treatment Older Cohort | Distribution of Diplopia Frequency at 8 Weeks (Parent-reported) | Up to 10 times a day | 0 Participants |
| Binocular Computer Game Treatment Older Cohort | Distribution of Diplopia Frequency at 8 Weeks (Parent-reported) | Less than once a week | 1 Participants |
| Binocular Computer Game Treatment Older Cohort | Distribution of Diplopia Frequency at 8 Weeks (Parent-reported) | All the time | 0 Participants |
| Binocular Computer Game Treatment Older Cohort | Distribution of Diplopia Frequency at 8 Weeks (Parent-reported) | Once a week | 0 Participants |
| Binocular Computer Game Treatment Older Cohort | Distribution of Diplopia Frequency at 8 Weeks (Parent-reported) | Once a day | 0 Participants |
| Continued Spectacle Correction Older Cohort | Distribution of Diplopia Frequency at 8 Weeks (Parent-reported) | More than 10 times a day | 0 Participants |
| Continued Spectacle Correction Older Cohort | Distribution of Diplopia Frequency at 8 Weeks (Parent-reported) | Once a day | 0 Participants |
| Continued Spectacle Correction Older Cohort | Distribution of Diplopia Frequency at 8 Weeks (Parent-reported) | Once a week | 0 Participants |
| Continued Spectacle Correction Older Cohort | Distribution of Diplopia Frequency at 8 Weeks (Parent-reported) | Up to 10 times a day | 0 Participants |
| Continued Spectacle Correction Older Cohort | Distribution of Diplopia Frequency at 8 Weeks (Parent-reported) | All the time | 0 Participants |
| Continued Spectacle Correction Older Cohort | Distribution of Diplopia Frequency at 8 Weeks (Parent-reported) | Less than once a week | 1 Participants |
| Continued Spectacle Correction Older Cohort | Distribution of Diplopia Frequency at 8 Weeks (Parent-reported) | Never | 67 Participants |
| Binocular Computer Game Treatment Younger Cohort | Distribution of Diplopia Frequency at 8 Weeks (Parent-reported) | Once a day | 0 Participants |
| Binocular Computer Game Treatment Younger Cohort | Distribution of Diplopia Frequency at 8 Weeks (Parent-reported) | Never | 84 Participants |
| Binocular Computer Game Treatment Younger Cohort | Distribution of Diplopia Frequency at 8 Weeks (Parent-reported) | Less than once a week | 2 Participants |
| Binocular Computer Game Treatment Younger Cohort | Distribution of Diplopia Frequency at 8 Weeks (Parent-reported) | Once a week | 0 Participants |
| Binocular Computer Game Treatment Younger Cohort | Distribution of Diplopia Frequency at 8 Weeks (Parent-reported) | Up to 10 times a day | 0 Participants |
| Binocular Computer Game Treatment Younger Cohort | Distribution of Diplopia Frequency at 8 Weeks (Parent-reported) | More than 10 times a day | 0 Participants |
| Binocular Computer Game Treatment Younger Cohort | Distribution of Diplopia Frequency at 8 Weeks (Parent-reported) | All the time | 0 Participants |
| Continued Spectacle Correction Younger Cohort | Distribution of Diplopia Frequency at 8 Weeks (Parent-reported) | Once a week | 0 Participants |
| Continued Spectacle Correction Younger Cohort | Distribution of Diplopia Frequency at 8 Weeks (Parent-reported) | All the time | 0 Participants |
| Continued Spectacle Correction Younger Cohort | Distribution of Diplopia Frequency at 8 Weeks (Parent-reported) | More than 10 times a day | 0 Participants |
| Continued Spectacle Correction Younger Cohort | Distribution of Diplopia Frequency at 8 Weeks (Parent-reported) | Less than once a week | 0 Participants |
| Continued Spectacle Correction Younger Cohort | Distribution of Diplopia Frequency at 8 Weeks (Parent-reported) | Never | 84 Participants |
| Continued Spectacle Correction Younger Cohort | Distribution of Diplopia Frequency at 8 Weeks (Parent-reported) | Up to 10 times a day | 0 Participants |
| Continued Spectacle Correction Younger Cohort | Distribution of Diplopia Frequency at 8 Weeks (Parent-reported) | Once a day | 0 Participants |
Comparison: The frequency of diplopia, across categories of diplopia, was compared between the treatment groups using the Cochran-Armitage trend test.p-value: >0.99Cochran-Armitage trend test
Secondary
Distribution of Diplopia Frequency at 8 Weeks (Participant-reported)
The proportion of subjects with each level of diplopia frequency will be reported by treatment group at 8 weeks. A standardized questionnaire was administered to participants and their parents to assess the presence and frequency of any diplopia since the last study visit.
Time frame: 8 weeks
Population: As this was a safety outcome, all visit information was recorded, regardless of whether or not it was collected in the analysis window.
| Arm | Measure | Group | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|---|
| Binocular Computer Game Treatment Older Cohort | Distribution of Diplopia Frequency at 8 Weeks (Participant-reported) | Never | 63 Participants |
| Binocular Computer Game Treatment Older Cohort | Distribution of Diplopia Frequency at 8 Weeks (Participant-reported) | More than 10 times a day | 0 Participants |
| Binocular Computer Game Treatment Older Cohort | Distribution of Diplopia Frequency at 8 Weeks (Participant-reported) | Up to 10 times a day | 0 Participants |
| Binocular Computer Game Treatment Older Cohort | Distribution of Diplopia Frequency at 8 Weeks (Participant-reported) | Less than once a week | 5 Participants |
| Binocular Computer Game Treatment Older Cohort | Distribution of Diplopia Frequency at 8 Weeks (Participant-reported) | All the time | 0 Participants |
| Binocular Computer Game Treatment Older Cohort | Distribution of Diplopia Frequency at 8 Weeks (Participant-reported) | Once a week | 0 Participants |
| Binocular Computer Game Treatment Older Cohort | Distribution of Diplopia Frequency at 8 Weeks (Participant-reported) | Once a day | 0 Participants |
| Continued Spectacle Correction Older Cohort | Distribution of Diplopia Frequency at 8 Weeks (Participant-reported) | More than 10 times a day | 0 Participants |
| Continued Spectacle Correction Older Cohort | Distribution of Diplopia Frequency at 8 Weeks (Participant-reported) | Once a day | 1 Participants |
| Continued Spectacle Correction Older Cohort | Distribution of Diplopia Frequency at 8 Weeks (Participant-reported) | Once a week | 0 Participants |
| Continued Spectacle Correction Older Cohort | Distribution of Diplopia Frequency at 8 Weeks (Participant-reported) | Up to 10 times a day | 0 Participants |
| Continued Spectacle Correction Older Cohort | Distribution of Diplopia Frequency at 8 Weeks (Participant-reported) | All the time | 0 Participants |
| Continued Spectacle Correction Older Cohort | Distribution of Diplopia Frequency at 8 Weeks (Participant-reported) | Less than once a week | 2 Participants |
| Continued Spectacle Correction Older Cohort | Distribution of Diplopia Frequency at 8 Weeks (Participant-reported) | Never | 65 Participants |
| Binocular Computer Game Treatment Younger Cohort | Distribution of Diplopia Frequency at 8 Weeks (Participant-reported) | Once a day | 2 Participants |
| Binocular Computer Game Treatment Younger Cohort | Distribution of Diplopia Frequency at 8 Weeks (Participant-reported) | Never | 78 Participants |
| Binocular Computer Game Treatment Younger Cohort | Distribution of Diplopia Frequency at 8 Weeks (Participant-reported) | Less than once a week | 4 Participants |
| Binocular Computer Game Treatment Younger Cohort | Distribution of Diplopia Frequency at 8 Weeks (Participant-reported) | Once a week | 1 Participants |
| Binocular Computer Game Treatment Younger Cohort | Distribution of Diplopia Frequency at 8 Weeks (Participant-reported) | Up to 10 times a day | 1 Participants |
| Binocular Computer Game Treatment Younger Cohort | Distribution of Diplopia Frequency at 8 Weeks (Participant-reported) | More than 10 times a day | 0 Participants |
| Binocular Computer Game Treatment Younger Cohort | Distribution of Diplopia Frequency at 8 Weeks (Participant-reported) | All the time | 0 Participants |
| Continued Spectacle Correction Younger Cohort | Distribution of Diplopia Frequency at 8 Weeks (Participant-reported) | Once a week | 1 Participants |
| Continued Spectacle Correction Younger Cohort | Distribution of Diplopia Frequency at 8 Weeks (Participant-reported) | All the time | 1 Participants |
| Continued Spectacle Correction Younger Cohort | Distribution of Diplopia Frequency at 8 Weeks (Participant-reported) | More than 10 times a day | 0 Participants |
| Continued Spectacle Correction Younger Cohort | Distribution of Diplopia Frequency at 8 Weeks (Participant-reported) | Less than once a week | 4 Participants |
| Continued Spectacle Correction Younger Cohort | Distribution of Diplopia Frequency at 8 Weeks (Participant-reported) | Never | 78 Participants |
| Continued Spectacle Correction Younger Cohort | Distribution of Diplopia Frequency at 8 Weeks (Participant-reported) | Up to 10 times a day | 0 Participants |
| Continued Spectacle Correction Younger Cohort | Distribution of Diplopia Frequency at 8 Weeks (Participant-reported) | Once a day | 0 Participants |
Comparison: The frequency of diplopia, across categories of diplopia, was compared between the treatment groups using the Cochran-Armitage trend test.p-value: >0.99Cochran-Armitage trend test
Secondary
Distribution of Stereoacuity Scores at 4 Weeks
Stereoacuity will be tested at near in current refractive correction using the Randot Butterfly and Randot Preschool stereoacuity tests. Stereoacuity scores (measure as seconds of arc) were calculated based on the Randot Butterfly (scores: 2000, Nil) and Randot Preschool stereoacuity (scores: 800, 400, 200, 100, 60 and 40) test methods. Lower scores indicate better stereoacuity. Results of the Randot Butterfly test were analyzed as 2000 seconds of arc (if correct response). Nil was assigned a score of 4000 seconds of arc and was defined as (1) an incorrect response on the butterfly in absence of a correct response on the 800 seconds of arc level of the Randot Preschool stereoacuity test or (2) an incorrect response on the 800 seconds of arc level if the butterfly was not attempted.
Time frame: 4 weeks
Population: Limited to those with follow-up visits completed within the pre-specified analysis window
| Arm | Measure | Category | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|---|
| Binocular Computer Game Treatment Older Cohort | Distribution of Stereoacuity Scores at 4 Weeks | 200 | 3 Participants |
| Binocular Computer Game Treatment Older Cohort | Distribution of Stereoacuity Scores at 4 Weeks | 60 | 2 Participants |
| Binocular Computer Game Treatment Older Cohort | Distribution of Stereoacuity Scores at 4 Weeks | 800 | 9 Participants |
| Binocular Computer Game Treatment Older Cohort | Distribution of Stereoacuity Scores at 4 Weeks | 2000 | 11 Participants |
| Binocular Computer Game Treatment Older Cohort | Distribution of Stereoacuity Scores at 4 Weeks | 100 | 4 Participants |
| Binocular Computer Game Treatment Older Cohort | Distribution of Stereoacuity Scores at 4 Weeks | Missing/Not done | 0 Participants |
| Binocular Computer Game Treatment Older Cohort | Distribution of Stereoacuity Scores at 4 Weeks | 400 | 7 Participants |
| Binocular Computer Game Treatment Older Cohort | Distribution of Stereoacuity Scores at 4 Weeks | Nil | 31 Participants |
| Binocular Computer Game Treatment Older Cohort | Distribution of Stereoacuity Scores at 4 Weeks | 40 | 2 Participants |
| Continued Spectacle Correction Older Cohort | Distribution of Stereoacuity Scores at 4 Weeks | 60 | 2 Participants |
| Continued Spectacle Correction Older Cohort | Distribution of Stereoacuity Scores at 4 Weeks | 40 | 1 Participants |
| Continued Spectacle Correction Older Cohort | Distribution of Stereoacuity Scores at 4 Weeks | Nil | 25 Participants |
| Continued Spectacle Correction Older Cohort | Distribution of Stereoacuity Scores at 4 Weeks | 100 | 12 Participants |
| Continued Spectacle Correction Older Cohort | Distribution of Stereoacuity Scores at 4 Weeks | 200 | 5 Participants |
| Continued Spectacle Correction Older Cohort | Distribution of Stereoacuity Scores at 4 Weeks | 400 | 6 Participants |
| Continued Spectacle Correction Older Cohort | Distribution of Stereoacuity Scores at 4 Weeks | Missing/Not done | 0 Participants |
| Continued Spectacle Correction Older Cohort | Distribution of Stereoacuity Scores at 4 Weeks | 800 | 5 Participants |
| Continued Spectacle Correction Older Cohort | Distribution of Stereoacuity Scores at 4 Weeks | 2000 | 11 Participants |
| Binocular Computer Game Treatment Younger Cohort | Distribution of Stereoacuity Scores at 4 Weeks | Nil | 24 Participants |
| Binocular Computer Game Treatment Younger Cohort | Distribution of Stereoacuity Scores at 4 Weeks | 60 | 3 Participants |
| Binocular Computer Game Treatment Younger Cohort | Distribution of Stereoacuity Scores at 4 Weeks | 2000 | 8 Participants |
| Binocular Computer Game Treatment Younger Cohort | Distribution of Stereoacuity Scores at 4 Weeks | 400 | 10 Participants |
| Binocular Computer Game Treatment Younger Cohort | Distribution of Stereoacuity Scores at 4 Weeks | Missing/Not done | 6 Participants |
| Binocular Computer Game Treatment Younger Cohort | Distribution of Stereoacuity Scores at 4 Weeks | 40 | 2 Participants |
| Binocular Computer Game Treatment Younger Cohort | Distribution of Stereoacuity Scores at 4 Weeks | 200 | 9 Participants |
| Binocular Computer Game Treatment Younger Cohort | Distribution of Stereoacuity Scores at 4 Weeks | 100 | 10 Participants |
| Binocular Computer Game Treatment Younger Cohort | Distribution of Stereoacuity Scores at 4 Weeks | 800 | 13 Participants |
| Continued Spectacle Correction Younger Cohort | Distribution of Stereoacuity Scores at 4 Weeks | 2000 | 10 Participants |
| Continued Spectacle Correction Younger Cohort | Distribution of Stereoacuity Scores at 4 Weeks | 100 | 6 Participants |
| Continued Spectacle Correction Younger Cohort | Distribution of Stereoacuity Scores at 4 Weeks | 60 | 5 Participants |
| Continued Spectacle Correction Younger Cohort | Distribution of Stereoacuity Scores at 4 Weeks | Missing/Not done | 8 Participants |
| Continued Spectacle Correction Younger Cohort | Distribution of Stereoacuity Scores at 4 Weeks | 800 | 7 Participants |
| Continued Spectacle Correction Younger Cohort | Distribution of Stereoacuity Scores at 4 Weeks | 200 | 9 Participants |
| Continued Spectacle Correction Younger Cohort | Distribution of Stereoacuity Scores at 4 Weeks | 400 | 15 Participants |
| Continued Spectacle Correction Younger Cohort | Distribution of Stereoacuity Scores at 4 Weeks | 40 | 3 Participants |
| Continued Spectacle Correction Younger Cohort | Distribution of Stereoacuity Scores at 4 Weeks | Nil | 21 Participants |
Secondary
Distribution of Stereoacuity Scores at 8 Weeks
Stereoacuity will be tested at near in current refractive correction using the Randot Butterfly and Randot Preschool stereoacuity tests. Stereoacuity scores (measure as seconds of arc) were calculated based on the Randot Butterfly (scores: 2000, Nil) and Randot Preschool stereoacuity (scores: 800, 400, 200, 100, 60 and 40) test methods. Lower scores indicate better stereoacuity. Results of the Randot Butterfly test were analyzed as 2000 seconds of arc (if correct response). Nil was assigned a score of 4000 seconds of arc and was defined as (1) an incorrect response on the butterfly in absence of a correct response on the 800 seconds of arc level of the Randot Preschool stereoacuity test or (2) an incorrect response on the 800 seconds of arc level if the butterfly was not attempted.
Time frame: 8 weeks
Population: Limited to those with follow-up visits completed within the pre-specified analysis window
| Arm | Measure | Group | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|---|
| Binocular Computer Game Treatment Older Cohort | Distribution of Stereoacuity Scores at 8 Weeks | 60 | 2 Participants |
| Binocular Computer Game Treatment Older Cohort | Distribution of Stereoacuity Scores at 8 Weeks | 40 | 3 Participants |
| Binocular Computer Game Treatment Older Cohort | Distribution of Stereoacuity Scores at 8 Weeks | 200 | 5 Participants |
| Binocular Computer Game Treatment Older Cohort | Distribution of Stereoacuity Scores at 8 Weeks | Nil | 31 Participants |
| Binocular Computer Game Treatment Older Cohort | Distribution of Stereoacuity Scores at 8 Weeks | 2000 | 11 Participants |
| Binocular Computer Game Treatment Older Cohort | Distribution of Stereoacuity Scores at 8 Weeks | 800 | 5 Participants |
| Binocular Computer Game Treatment Older Cohort | Distribution of Stereoacuity Scores at 8 Weeks | 100 | 6 Participants |
| Binocular Computer Game Treatment Older Cohort | Distribution of Stereoacuity Scores at 8 Weeks | 400 | 4 Participants |
| Continued Spectacle Correction Older Cohort | Distribution of Stereoacuity Scores at 8 Weeks | 800 | 8 Participants |
| Continued Spectacle Correction Older Cohort | Distribution of Stereoacuity Scores at 8 Weeks | 60 | 3 Participants |
| Continued Spectacle Correction Older Cohort | Distribution of Stereoacuity Scores at 8 Weeks | Nil | 24 Participants |
| Continued Spectacle Correction Older Cohort | Distribution of Stereoacuity Scores at 8 Weeks | 400 | 2 Participants |
| Continued Spectacle Correction Older Cohort | Distribution of Stereoacuity Scores at 8 Weeks | 200 | 11 Participants |
| Continued Spectacle Correction Older Cohort | Distribution of Stereoacuity Scores at 8 Weeks | 40 | 1 Participants |
| Continued Spectacle Correction Older Cohort | Distribution of Stereoacuity Scores at 8 Weeks | 2000 | 10 Participants |
| Continued Spectacle Correction Older Cohort | Distribution of Stereoacuity Scores at 8 Weeks | 100 | 9 Participants |
| Binocular Computer Game Treatment Younger Cohort | Distribution of Stereoacuity Scores at 8 Weeks | 400 | 9 Participants |
| Binocular Computer Game Treatment Younger Cohort | Distribution of Stereoacuity Scores at 8 Weeks | Nil | 28 Participants |
| Binocular Computer Game Treatment Younger Cohort | Distribution of Stereoacuity Scores at 8 Weeks | 100 | 10 Participants |
| Binocular Computer Game Treatment Younger Cohort | Distribution of Stereoacuity Scores at 8 Weeks | 2000 | 11 Participants |
| Binocular Computer Game Treatment Younger Cohort | Distribution of Stereoacuity Scores at 8 Weeks | 800 | 10 Participants |
| Binocular Computer Game Treatment Younger Cohort | Distribution of Stereoacuity Scores at 8 Weeks | 60 | 2 Participants |
| Binocular Computer Game Treatment Younger Cohort | Distribution of Stereoacuity Scores at 8 Weeks | 40 | 3 Participants |
| Binocular Computer Game Treatment Younger Cohort | Distribution of Stereoacuity Scores at 8 Weeks | 200 | 12 Participants |
| Continued Spectacle Correction Younger Cohort | Distribution of Stereoacuity Scores at 8 Weeks | 40 | 5 Participants |
| Continued Spectacle Correction Younger Cohort | Distribution of Stereoacuity Scores at 8 Weeks | 2000 | 8 Participants |
| Continued Spectacle Correction Younger Cohort | Distribution of Stereoacuity Scores at 8 Weeks | 800 | 15 Participants |
| Continued Spectacle Correction Younger Cohort | Distribution of Stereoacuity Scores at 8 Weeks | Nil | 25 Participants |
| Continued Spectacle Correction Younger Cohort | Distribution of Stereoacuity Scores at 8 Weeks | 400 | 12 Participants |
| Continued Spectacle Correction Younger Cohort | Distribution of Stereoacuity Scores at 8 Weeks | 200 | 9 Participants |
| Continued Spectacle Correction Younger Cohort | Distribution of Stereoacuity Scores at 8 Weeks | 100 | 7 Participants |
| Continued Spectacle Correction Younger Cohort | Distribution of Stereoacuity Scores at 8 Weeks | 60 | 3 Participants |
Secondary
Distribution of Stereoacuity Scores (Participants With no History of Strabismus)
Stereoacuity was tested at near in current refractive correction. Stereoacuity scores (measure as seconds of arc) were calculated based on the Randot Butterfly (scores: 2000, Nil) and Randot Preschool stereoacuity (scores: 800, 400, 200, 100, 60 and 40) test methods. Lower scores indicate better stereoacuity. Results of the Randot Butterfly test were analyzed as 2000 seconds of arc (if correct response). Nil was assigned a score of 4000 seconds of arc and was defined as (1) an incorrect response on the butterfly in absence of a correct response on the 800 seconds of arc level of the Randot Preschool stereoacuity test or (2) an incorrect response on the 800 seconds of arc level if the butterfly was not attempted.
Time frame: 4 weeks
Population: Only participants with no history of strabismus are analyzed, as mentioned in the outcome title.
| Arm | Measure | Category | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|---|
| Binocular Computer Game Treatment Older Cohort | Distribution of Stereoacuity Scores (Participants With no History of Strabismus) | 400 | 5 Participants |
| Binocular Computer Game Treatment Older Cohort | Distribution of Stereoacuity Scores (Participants With no History of Strabismus) | 2000 | 3 Participants |
| Binocular Computer Game Treatment Older Cohort | Distribution of Stereoacuity Scores (Participants With no History of Strabismus) | Missing/Not Done | 0 Participants |
| Binocular Computer Game Treatment Older Cohort | Distribution of Stereoacuity Scores (Participants With no History of Strabismus) | 800 | 2 Participants |
| Binocular Computer Game Treatment Older Cohort | Distribution of Stereoacuity Scores (Participants With no History of Strabismus) | 40 | 2 Participants |
| Binocular Computer Game Treatment Older Cohort | Distribution of Stereoacuity Scores (Participants With no History of Strabismus) | 60 | 2 Participants |
| Binocular Computer Game Treatment Older Cohort | Distribution of Stereoacuity Scores (Participants With no History of Strabismus) | 100 | 4 Participants |
| Binocular Computer Game Treatment Older Cohort | Distribution of Stereoacuity Scores (Participants With no History of Strabismus) | Nil | 8 Participants |
| Binocular Computer Game Treatment Older Cohort | Distribution of Stereoacuity Scores (Participants With no History of Strabismus) | 200 | 1 Participants |
| Continued Spectacle Correction Older Cohort | Distribution of Stereoacuity Scores (Participants With no History of Strabismus) | Nil | 7 Participants |
| Continued Spectacle Correction Older Cohort | Distribution of Stereoacuity Scores (Participants With no History of Strabismus) | 800 | 3 Participants |
| Continued Spectacle Correction Older Cohort | Distribution of Stereoacuity Scores (Participants With no History of Strabismus) | Missing/Not Done | 0 Participants |
| Continued Spectacle Correction Older Cohort | Distribution of Stereoacuity Scores (Participants With no History of Strabismus) | 2000 | 5 Participants |
| Continued Spectacle Correction Older Cohort | Distribution of Stereoacuity Scores (Participants With no History of Strabismus) | 400 | 4 Participants |
| Continued Spectacle Correction Older Cohort | Distribution of Stereoacuity Scores (Participants With no History of Strabismus) | 200 | 4 Participants |
| Continued Spectacle Correction Older Cohort | Distribution of Stereoacuity Scores (Participants With no History of Strabismus) | 100 | 12 Participants |
| Continued Spectacle Correction Older Cohort | Distribution of Stereoacuity Scores (Participants With no History of Strabismus) | 60 | 1 Participants |
| Continued Spectacle Correction Older Cohort | Distribution of Stereoacuity Scores (Participants With no History of Strabismus) | 40 | 1 Participants |
| Binocular Computer Game Treatment Younger Cohort | Distribution of Stereoacuity Scores (Participants With no History of Strabismus) | Nil | 11 Participants |
| Binocular Computer Game Treatment Younger Cohort | Distribution of Stereoacuity Scores (Participants With no History of Strabismus) | Missing/Not Done | 4 Participants |
| Binocular Computer Game Treatment Younger Cohort | Distribution of Stereoacuity Scores (Participants With no History of Strabismus) | 40 | 0 Participants |
| Binocular Computer Game Treatment Younger Cohort | Distribution of Stereoacuity Scores (Participants With no History of Strabismus) | 60 | 3 Participants |
| Binocular Computer Game Treatment Younger Cohort | Distribution of Stereoacuity Scores (Participants With no History of Strabismus) | 400 | 8 Participants |
| Binocular Computer Game Treatment Younger Cohort | Distribution of Stereoacuity Scores (Participants With no History of Strabismus) | 2000 | 5 Participants |
| Binocular Computer Game Treatment Younger Cohort | Distribution of Stereoacuity Scores (Participants With no History of Strabismus) | 800 | 8 Participants |
| Binocular Computer Game Treatment Younger Cohort | Distribution of Stereoacuity Scores (Participants With no History of Strabismus) | 200 | 9 Participants |
| Binocular Computer Game Treatment Younger Cohort | Distribution of Stereoacuity Scores (Participants With no History of Strabismus) | 100 | 10 Participants |
| Continued Spectacle Correction Younger Cohort | Distribution of Stereoacuity Scores (Participants With no History of Strabismus) | Nil | 8 Participants |
| Continued Spectacle Correction Younger Cohort | Distribution of Stereoacuity Scores (Participants With no History of Strabismus) | 400 | 10 Participants |
| Continued Spectacle Correction Younger Cohort | Distribution of Stereoacuity Scores (Participants With no History of Strabismus) | 200 | 9 Participants |
| Continued Spectacle Correction Younger Cohort | Distribution of Stereoacuity Scores (Participants With no History of Strabismus) | Missing/Not Done | 4 Participants |
| Continued Spectacle Correction Younger Cohort | Distribution of Stereoacuity Scores (Participants With no History of Strabismus) | 40 | 1 Participants |
| Continued Spectacle Correction Younger Cohort | Distribution of Stereoacuity Scores (Participants With no History of Strabismus) | 100 | 4 Participants |
| Continued Spectacle Correction Younger Cohort | Distribution of Stereoacuity Scores (Participants With no History of Strabismus) | 2000 | 7 Participants |
| Continued Spectacle Correction Younger Cohort | Distribution of Stereoacuity Scores (Participants With no History of Strabismus) | 800 | 4 Participants |
| Continued Spectacle Correction Younger Cohort | Distribution of Stereoacuity Scores (Participants With no History of Strabismus) | 60 | 4 Participants |
Secondary
Distribution of Stereoacuity Scores (Participants With no History of Strabismus)
Stereoacuity was tested at near in current refractive correction. Stereoacuity scores (measure as seconds of arc) were calculated based on the Randot Butterfly (scores: 2000, Nil) and Randot Preschool stereoacuity (scores: 800, 400, 200, 100, 60 and 40) test methods. Lower scores indicate better stereoacuity. Results of the Randot Butterfly test were analyzed as 2000 seconds of arc (if correct response). Nil was assigned a score of 4000 seconds of arc and was defined as (1) an incorrect response on the butterfly in absence of a correct response on the 800 seconds of arc level of the Randot Preschool stereoacuity test or (2) an incorrect response on the 800 seconds of arc level if the butterfly was not attempted.
Time frame: 8 weeks
Population: Only participants with no history of strabismus are analyzed, as mentioned in the outcome title.
| Arm | Measure | Group | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|---|
| Binocular Computer Game Treatment Older Cohort | Distribution of Stereoacuity Scores (Participants With no History of Strabismus) | 200 | 5 Participants |
| Binocular Computer Game Treatment Older Cohort | Distribution of Stereoacuity Scores (Participants With no History of Strabismus) | 2000 | 3 Participants |
| Binocular Computer Game Treatment Older Cohort | Distribution of Stereoacuity Scores (Participants With no History of Strabismus) | 60 | 2 Participants |
| Binocular Computer Game Treatment Older Cohort | Distribution of Stereoacuity Scores (Participants With no History of Strabismus) | 40 | 3 Participants |
| Binocular Computer Game Treatment Older Cohort | Distribution of Stereoacuity Scores (Participants With no History of Strabismus) | 800 | 1 Participants |
| Binocular Computer Game Treatment Older Cohort | Distribution of Stereoacuity Scores (Participants With no History of Strabismus) | 100 | 4 Participants |
| Binocular Computer Game Treatment Older Cohort | Distribution of Stereoacuity Scores (Participants With no History of Strabismus) | 400 | 1 Participants |
| Binocular Computer Game Treatment Older Cohort | Distribution of Stereoacuity Scores (Participants With no History of Strabismus) | Nil | 8 Participants |
| Continued Spectacle Correction Older Cohort | Distribution of Stereoacuity Scores (Participants With no History of Strabismus) | Nil | 8 Participants |
| Continued Spectacle Correction Older Cohort | Distribution of Stereoacuity Scores (Participants With no History of Strabismus) | 100 | 9 Participants |
| Continued Spectacle Correction Older Cohort | Distribution of Stereoacuity Scores (Participants With no History of Strabismus) | 60 | 3 Participants |
| Continued Spectacle Correction Older Cohort | Distribution of Stereoacuity Scores (Participants With no History of Strabismus) | 40 | 0 Participants |
| Continued Spectacle Correction Older Cohort | Distribution of Stereoacuity Scores (Participants With no History of Strabismus) | 2000 | 7 Participants |
| Continued Spectacle Correction Older Cohort | Distribution of Stereoacuity Scores (Participants With no History of Strabismus) | 800 | 1 Participants |
| Continued Spectacle Correction Older Cohort | Distribution of Stereoacuity Scores (Participants With no History of Strabismus) | 400 | 1 Participants |
| Continued Spectacle Correction Older Cohort | Distribution of Stereoacuity Scores (Participants With no History of Strabismus) | 200 | 9 Participants |
| Binocular Computer Game Treatment Younger Cohort | Distribution of Stereoacuity Scores (Participants With no History of Strabismus) | 2000 | 8 Participants |
| Binocular Computer Game Treatment Younger Cohort | Distribution of Stereoacuity Scores (Participants With no History of Strabismus) | 60 | 2 Participants |
| Binocular Computer Game Treatment Younger Cohort | Distribution of Stereoacuity Scores (Participants With no History of Strabismus) | 100 | 9 Participants |
| Binocular Computer Game Treatment Younger Cohort | Distribution of Stereoacuity Scores (Participants With no History of Strabismus) | 400 | 5 Participants |
| Binocular Computer Game Treatment Younger Cohort | Distribution of Stereoacuity Scores (Participants With no History of Strabismus) | 200 | 11 Participants |
| Binocular Computer Game Treatment Younger Cohort | Distribution of Stereoacuity Scores (Participants With no History of Strabismus) | 40 | 3 Participants |
| Binocular Computer Game Treatment Younger Cohort | Distribution of Stereoacuity Scores (Participants With no History of Strabismus) | Nil | 14 Participants |
| Binocular Computer Game Treatment Younger Cohort | Distribution of Stereoacuity Scores (Participants With no History of Strabismus) | 800 | 5 Participants |
| Continued Spectacle Correction Younger Cohort | Distribution of Stereoacuity Scores (Participants With no History of Strabismus) | 60 | 2 Participants |
| Continued Spectacle Correction Younger Cohort | Distribution of Stereoacuity Scores (Participants With no History of Strabismus) | 40 | 4 Participants |
| Continued Spectacle Correction Younger Cohort | Distribution of Stereoacuity Scores (Participants With no History of Strabismus) | Nil | 11 Participants |
| Continued Spectacle Correction Younger Cohort | Distribution of Stereoacuity Scores (Participants With no History of Strabismus) | 2000 | 4 Participants |
| Continued Spectacle Correction Younger Cohort | Distribution of Stereoacuity Scores (Participants With no History of Strabismus) | 800 | 8 Participants |
| Continued Spectacle Correction Younger Cohort | Distribution of Stereoacuity Scores (Participants With no History of Strabismus) | 400 | 8 Participants |
| Continued Spectacle Correction Younger Cohort | Distribution of Stereoacuity Scores (Participants With no History of Strabismus) | 200 | 8 Participants |
| Continued Spectacle Correction Younger Cohort | Distribution of Stereoacuity Scores (Participants With no History of Strabismus) | 100 | 6 Participants |
Secondary
Frequency of Adverse Symptoms (Symptom Survey)
The child and parent(s) will complete a 5-item symptom survey regarding the presence of various ocular symptoms within the past 2 weeks at enrollment and at each visit. The distribution of scores on each symptom survey item will be described for the enrollment exam and the 4-week exam for each treatment group. The distribution of change in scores on each symptom survey item will also be described for each treatment group.
Time frame: 4 weeks
Population: There were 3 participants in the older cohort control treatment group with responses of 'Not wearing spectacles'. These participants were excluded from the percentage tabulations (only the number is reported) in the table and any analyses specific to these Symptom Survey items.
| Arm | Measure | Group | Category | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|---|---|
| Binocular Computer Game Treatment Older Cohort | Frequency of Adverse Symptoms (Symptom Survey) | Blurred Vision | Almost Always | 0 Participants |
| Binocular Computer Game Treatment Older Cohort | Frequency of Adverse Symptoms (Symptom Survey) | Blurred Vision | Often | 0 Participants |
| Binocular Computer Game Treatment Older Cohort | Frequency of Adverse Symptoms (Symptom Survey) | Headache | Never | 38 Participants |
| Binocular Computer Game Treatment Older Cohort | Frequency of Adverse Symptoms (Symptom Survey) | Eyestrain | Almost Always | 1 Participants |
| Binocular Computer Game Treatment Older Cohort | Frequency of Adverse Symptoms (Symptom Survey) | Eyestrain | Never | 50 Participants |
| Binocular Computer Game Treatment Older Cohort | Frequency of Adverse Symptoms (Symptom Survey) | Take Off Spectacles | Never | 43 Participants |
| Binocular Computer Game Treatment Older Cohort | Frequency of Adverse Symptoms (Symptom Survey) | Blurred Vision | Almost Never | 3 Participants |
| Binocular Computer Game Treatment Older Cohort | Frequency of Adverse Symptoms (Symptom Survey) | Blurred Vision | Never | 61 Participants |
| Binocular Computer Game Treatment Older Cohort | Frequency of Adverse Symptoms (Symptom Survey) | Eyestrain | Almost Never | 7 Participants |
| Binocular Computer Game Treatment Older Cohort | Frequency of Adverse Symptoms (Symptom Survey) | Eyestrain | Often | 2 Participants |
| Binocular Computer Game Treatment Older Cohort | Frequency of Adverse Symptoms (Symptom Survey) | Look Over Spectacles | Sometimes | 13 Participants |
| Binocular Computer Game Treatment Older Cohort | Frequency of Adverse Symptoms (Symptom Survey) | Eyestrain | Sometimes | 9 Participants |
| Binocular Computer Game Treatment Older Cohort | Frequency of Adverse Symptoms (Symptom Survey) | Headache | Almost Always | 0 Participants |
| Binocular Computer Game Treatment Older Cohort | Frequency of Adverse Symptoms (Symptom Survey) | Take Off Spectacles | Almost Never | 13 Participants |
| Binocular Computer Game Treatment Older Cohort | Frequency of Adverse Symptoms (Symptom Survey) | Look Over Spectacles | Almost Never | 11 Participants |
| Binocular Computer Game Treatment Older Cohort | Frequency of Adverse Symptoms (Symptom Survey) | Look Over Spectacles | Never | 44 Participants |
| Binocular Computer Game Treatment Older Cohort | Frequency of Adverse Symptoms (Symptom Survey) | Take Off Spectacles | Sometimes | 12 Participants |
| Binocular Computer Game Treatment Older Cohort | Frequency of Adverse Symptoms (Symptom Survey) | Look Over Spectacles | Almost Always | 0 Participants |
| Binocular Computer Game Treatment Older Cohort | Frequency of Adverse Symptoms (Symptom Survey) | Headache | Often | 3 Participants |
| Binocular Computer Game Treatment Older Cohort | Frequency of Adverse Symptoms (Symptom Survey) | Take Off Spectacles | Often | 1 Participants |
| Binocular Computer Game Treatment Older Cohort | Frequency of Adverse Symptoms (Symptom Survey) | Look Over Spectacles | Often | 1 Participants |
| Binocular Computer Game Treatment Older Cohort | Frequency of Adverse Symptoms (Symptom Survey) | Take Off Spectacles | Almost Always | 0 Participants |
| Binocular Computer Game Treatment Older Cohort | Frequency of Adverse Symptoms (Symptom Survey) | Blurred Vision | Sometimes | 5 Participants |
| Binocular Computer Game Treatment Older Cohort | Frequency of Adverse Symptoms (Symptom Survey) | Headache | Sometimes | 8 Participants |
| Binocular Computer Game Treatment Older Cohort | Frequency of Adverse Symptoms (Symptom Survey) | Headache | Almost Never | 20 Participants |
| Continued Spectacle Correction Older Cohort | Frequency of Adverse Symptoms (Symptom Survey) | Look Over Spectacles | Sometimes | 11 Participants |
| Continued Spectacle Correction Older Cohort | Frequency of Adverse Symptoms (Symptom Survey) | Look Over Spectacles | Often | 5 Participants |
| Continued Spectacle Correction Older Cohort | Frequency of Adverse Symptoms (Symptom Survey) | Look Over Spectacles | Almost Always | 0 Participants |
| Continued Spectacle Correction Older Cohort | Frequency of Adverse Symptoms (Symptom Survey) | Take Off Spectacles | Never | 41 Participants |
| Continued Spectacle Correction Older Cohort | Frequency of Adverse Symptoms (Symptom Survey) | Take Off Spectacles | Almost Never | 14 Participants |
| Continued Spectacle Correction Older Cohort | Frequency of Adverse Symptoms (Symptom Survey) | Blurred Vision | Often | 1 Participants |
| Continued Spectacle Correction Older Cohort | Frequency of Adverse Symptoms (Symptom Survey) | Take Off Spectacles | Sometimes | 9 Participants |
| Continued Spectacle Correction Older Cohort | Frequency of Adverse Symptoms (Symptom Survey) | Take Off Spectacles | Often | 0 Participants |
| Continued Spectacle Correction Older Cohort | Frequency of Adverse Symptoms (Symptom Survey) | Take Off Spectacles | Almost Always | 0 Participants |
| Continued Spectacle Correction Older Cohort | Frequency of Adverse Symptoms (Symptom Survey) | Blurred Vision | Almost Always | 0 Participants |
| Continued Spectacle Correction Older Cohort | Frequency of Adverse Symptoms (Symptom Survey) | Eyestrain | Never | 46 Participants |
| Continued Spectacle Correction Older Cohort | Frequency of Adverse Symptoms (Symptom Survey) | Eyestrain | Almost Never | 13 Participants |
| Continued Spectacle Correction Older Cohort | Frequency of Adverse Symptoms (Symptom Survey) | Blurred Vision | Never | 57 Participants |
| Continued Spectacle Correction Older Cohort | Frequency of Adverse Symptoms (Symptom Survey) | Eyestrain | Sometimes | 7 Participants |
| Continued Spectacle Correction Older Cohort | Frequency of Adverse Symptoms (Symptom Survey) | Eyestrain | Often | 1 Participants |
| Continued Spectacle Correction Older Cohort | Frequency of Adverse Symptoms (Symptom Survey) | Eyestrain | Almost Always | 0 Participants |
| Continued Spectacle Correction Older Cohort | Frequency of Adverse Symptoms (Symptom Survey) | Blurred Vision | Almost Never | 8 Participants |
| Continued Spectacle Correction Older Cohort | Frequency of Adverse Symptoms (Symptom Survey) | Headache | Never | 38 Participants |
| Continued Spectacle Correction Older Cohort | Frequency of Adverse Symptoms (Symptom Survey) | Headache | Almost Never | 14 Participants |
| Continued Spectacle Correction Older Cohort | Frequency of Adverse Symptoms (Symptom Survey) | Headache | Sometimes | 12 Participants |
| Continued Spectacle Correction Older Cohort | Frequency of Adverse Symptoms (Symptom Survey) | Headache | Often | 3 Participants |
| Continued Spectacle Correction Older Cohort | Frequency of Adverse Symptoms (Symptom Survey) | Headache | Almost Always | 0 Participants |
| Continued Spectacle Correction Older Cohort | Frequency of Adverse Symptoms (Symptom Survey) | Look Over Spectacles | Never | 39 Participants |
| Continued Spectacle Correction Older Cohort | Frequency of Adverse Symptoms (Symptom Survey) | Look Over Spectacles | Almost Never | 9 Participants |
| Continued Spectacle Correction Older Cohort | Frequency of Adverse Symptoms (Symptom Survey) | Blurred Vision | Sometimes | 1 Participants |
| Binocular Computer Game Treatment Younger Cohort | Frequency of Adverse Symptoms (Symptom Survey) | Look Over Spectacles | Almost Always | 2 Participants |
| Binocular Computer Game Treatment Younger Cohort | Frequency of Adverse Symptoms (Symptom Survey) | Blurred Vision | Almost Always | 0 Participants |
| Binocular Computer Game Treatment Younger Cohort | Frequency of Adverse Symptoms (Symptom Survey) | Take Off Spectacles | Almost Never | 26 Participants |
| Binocular Computer Game Treatment Younger Cohort | Frequency of Adverse Symptoms (Symptom Survey) | Look Over Spectacles | Sometimes | 19 Participants |
| Binocular Computer Game Treatment Younger Cohort | Frequency of Adverse Symptoms (Symptom Survey) | Headache | Almost Never | 14 Participants |
| Binocular Computer Game Treatment Younger Cohort | Frequency of Adverse Symptoms (Symptom Survey) | Blurred Vision | Almost Never | 10 Participants |
| Binocular Computer Game Treatment Younger Cohort | Frequency of Adverse Symptoms (Symptom Survey) | Take Off Spectacles | Almost Always | 0 Participants |
| Binocular Computer Game Treatment Younger Cohort | Frequency of Adverse Symptoms (Symptom Survey) | Look Over Spectacles | Often | 6 Participants |
| Binocular Computer Game Treatment Younger Cohort | Frequency of Adverse Symptoms (Symptom Survey) | Headache | Sometimes | 9 Participants |
| Binocular Computer Game Treatment Younger Cohort | Frequency of Adverse Symptoms (Symptom Survey) | Take Off Spectacles | Often | 4 Participants |
| Binocular Computer Game Treatment Younger Cohort | Frequency of Adverse Symptoms (Symptom Survey) | Blurred Vision | Often | 1 Participants |
| Binocular Computer Game Treatment Younger Cohort | Frequency of Adverse Symptoms (Symptom Survey) | Blurred Vision | Sometimes | 5 Participants |
| Binocular Computer Game Treatment Younger Cohort | Frequency of Adverse Symptoms (Symptom Survey) | Look Over Spectacles | Never | 44 Participants |
| Binocular Computer Game Treatment Younger Cohort | Frequency of Adverse Symptoms (Symptom Survey) | Eyestrain | Almost Never | 15 Participants |
| Binocular Computer Game Treatment Younger Cohort | Frequency of Adverse Symptoms (Symptom Survey) | Take Off Spectacles | Never | 43 Participants |
| Binocular Computer Game Treatment Younger Cohort | Frequency of Adverse Symptoms (Symptom Survey) | Eyestrain | Sometimes | 17 Participants |
| Binocular Computer Game Treatment Younger Cohort | Frequency of Adverse Symptoms (Symptom Survey) | Blurred Vision | Never | 72 Participants |
| Binocular Computer Game Treatment Younger Cohort | Frequency of Adverse Symptoms (Symptom Survey) | Headache | Never | 60 Participants |
| Binocular Computer Game Treatment Younger Cohort | Frequency of Adverse Symptoms (Symptom Survey) | Look Over Spectacles | Almost Never | 17 Participants |
| Binocular Computer Game Treatment Younger Cohort | Frequency of Adverse Symptoms (Symptom Survey) | Take Off Spectacles | Sometimes | 15 Participants |
| Binocular Computer Game Treatment Younger Cohort | Frequency of Adverse Symptoms (Symptom Survey) | Eyestrain | Often | 3 Participants |
| Binocular Computer Game Treatment Younger Cohort | Frequency of Adverse Symptoms (Symptom Survey) | Eyestrain | Never | 53 Participants |
| Binocular Computer Game Treatment Younger Cohort | Frequency of Adverse Symptoms (Symptom Survey) | Headache | Often | 5 Participants |
| Binocular Computer Game Treatment Younger Cohort | Frequency of Adverse Symptoms (Symptom Survey) | Headache | Almost Always | 0 Participants |
| Binocular Computer Game Treatment Younger Cohort | Frequency of Adverse Symptoms (Symptom Survey) | Eyestrain | Almost Always | 0 Participants |
| Continued Spectacle Correction Younger Cohort | Frequency of Adverse Symptoms (Symptom Survey) | Headache | Often | 1 Participants |
| Continued Spectacle Correction Younger Cohort | Frequency of Adverse Symptoms (Symptom Survey) | Look Over Spectacles | Never | 40 Participants |
| Continued Spectacle Correction Younger Cohort | Frequency of Adverse Symptoms (Symptom Survey) | Take Off Spectacles | Never | 46 Participants |
| Continued Spectacle Correction Younger Cohort | Frequency of Adverse Symptoms (Symptom Survey) | Take Off Spectacles | Often | 1 Participants |
| Continued Spectacle Correction Younger Cohort | Frequency of Adverse Symptoms (Symptom Survey) | Blurred Vision | Never | 71 Participants |
| Continued Spectacle Correction Younger Cohort | Frequency of Adverse Symptoms (Symptom Survey) | Blurred Vision | Almost Never | 6 Participants |
| Continued Spectacle Correction Younger Cohort | Frequency of Adverse Symptoms (Symptom Survey) | Blurred Vision | Sometimes | 4 Participants |
| Continued Spectacle Correction Younger Cohort | Frequency of Adverse Symptoms (Symptom Survey) | Blurred Vision | Often | 2 Participants |
| Continued Spectacle Correction Younger Cohort | Frequency of Adverse Symptoms (Symptom Survey) | Blurred Vision | Almost Always | 0 Participants |
| Continued Spectacle Correction Younger Cohort | Frequency of Adverse Symptoms (Symptom Survey) | Eyestrain | Never | 58 Participants |
| Continued Spectacle Correction Younger Cohort | Frequency of Adverse Symptoms (Symptom Survey) | Eyestrain | Almost Never | 19 Participants |
| Continued Spectacle Correction Younger Cohort | Frequency of Adverse Symptoms (Symptom Survey) | Eyestrain | Sometimes | 6 Participants |
| Continued Spectacle Correction Younger Cohort | Frequency of Adverse Symptoms (Symptom Survey) | Headache | Never | 68 Participants |
| Continued Spectacle Correction Younger Cohort | Frequency of Adverse Symptoms (Symptom Survey) | Eyestrain | Often | 0 Participants |
| Continued Spectacle Correction Younger Cohort | Frequency of Adverse Symptoms (Symptom Survey) | Eyestrain | Almost Always | 0 Participants |
| Continued Spectacle Correction Younger Cohort | Frequency of Adverse Symptoms (Symptom Survey) | Headache | Almost Never | 13 Participants |
| Continued Spectacle Correction Younger Cohort | Frequency of Adverse Symptoms (Symptom Survey) | Headache | Sometimes | 1 Participants |
| Continued Spectacle Correction Younger Cohort | Frequency of Adverse Symptoms (Symptom Survey) | Headache | Almost Always | 0 Participants |
| Continued Spectacle Correction Younger Cohort | Frequency of Adverse Symptoms (Symptom Survey) | Look Over Spectacles | Almost Never | 19 Participants |
| Continued Spectacle Correction Younger Cohort | Frequency of Adverse Symptoms (Symptom Survey) | Look Over Spectacles | Sometimes | 17 Participants |
| Continued Spectacle Correction Younger Cohort | Frequency of Adverse Symptoms (Symptom Survey) | Look Over Spectacles | Often | 6 Participants |
| Continued Spectacle Correction Younger Cohort | Frequency of Adverse Symptoms (Symptom Survey) | Look Over Spectacles | Almost Always | 1 Participants |
| Continued Spectacle Correction Younger Cohort | Frequency of Adverse Symptoms (Symptom Survey) | Take Off Spectacles | Almost Never | 24 Participants |
| Continued Spectacle Correction Younger Cohort | Frequency of Adverse Symptoms (Symptom Survey) | Take Off Spectacles | Sometimes | 11 Participants |
| Continued Spectacle Correction Younger Cohort | Frequency of Adverse Symptoms (Symptom Survey) | Take Off Spectacles | Almost Always | 1 Participants |
Secondary
Frequency of Adverse Symptoms (Symptom Survey) at 8 Weeks
The child and parent(s) will complete a 5-item symptom survey regarding the presence of various ocular symptoms within the past 2 weeks at enrollment and at each visit. The distribution of scores on each symptom survey item will be described for the enrollment exam and the 4-week exam for each treatment group. The distribution of change in scores on each symptom survey item will also be described for each treatment group.
Time frame: 8 weeks
Population: There were 3 participants in the control treatment group with responses of 'Not wearing spectacles'. These participants were excluded from the percentage tabulations (only the number is reported) in the table and any analyses specific to these Symptom Survey items.
| Arm | Measure | Group | Category | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|---|---|
| Binocular Computer Game Treatment Older Cohort | Frequency of Adverse Symptoms (Symptom Survey) at 8 Weeks | Eyestrain | Never | 48 Participants |
| Binocular Computer Game Treatment Older Cohort | Frequency of Adverse Symptoms (Symptom Survey) at 8 Weeks | Eyestrain | Almost Always | 0 Participants |
| Binocular Computer Game Treatment Older Cohort | Frequency of Adverse Symptoms (Symptom Survey) at 8 Weeks | Headache | Almost Never | 13 Participants |
| Binocular Computer Game Treatment Older Cohort | Frequency of Adverse Symptoms (Symptom Survey) at 8 Weeks | Headache | Never | 44 Participants |
| Binocular Computer Game Treatment Older Cohort | Frequency of Adverse Symptoms (Symptom Survey) at 8 Weeks | Eyestrain | Almost Never | 9 Participants |
| Binocular Computer Game Treatment Older Cohort | Frequency of Adverse Symptoms (Symptom Survey) at 8 Weeks | Take Off Spectacles | Almost Never | 16 Participants |
| Binocular Computer Game Treatment Older Cohort | Frequency of Adverse Symptoms (Symptom Survey) at 8 Weeks | Eyestrain | Often | 1 Participants |
| Binocular Computer Game Treatment Older Cohort | Frequency of Adverse Symptoms (Symptom Survey) at 8 Weeks | Eyestrain | Sometimes | 9 Participants |
| Binocular Computer Game Treatment Older Cohort | Frequency of Adverse Symptoms (Symptom Survey) at 8 Weeks | Take Off Spectacles | Never | 40 Participants |
| Binocular Computer Game Treatment Older Cohort | Frequency of Adverse Symptoms (Symptom Survey) at 8 Weeks | Blurred Vision | Almost Never | 7 Participants |
| Binocular Computer Game Treatment Older Cohort | Frequency of Adverse Symptoms (Symptom Survey) at 8 Weeks | Take Off Spectacles | Often | 0 Participants |
| Binocular Computer Game Treatment Older Cohort | Frequency of Adverse Symptoms (Symptom Survey) at 8 Weeks | Look Over Spectacles | Almost Always | 0 Participants |
| Binocular Computer Game Treatment Older Cohort | Frequency of Adverse Symptoms (Symptom Survey) at 8 Weeks | Look Over Spectacles | Often | 1 Participants |
| Binocular Computer Game Treatment Older Cohort | Frequency of Adverse Symptoms (Symptom Survey) at 8 Weeks | Blurred Vision | Sometimes | 2 Participants |
| Binocular Computer Game Treatment Older Cohort | Frequency of Adverse Symptoms (Symptom Survey) at 8 Weeks | Blurred Vision | Never | 58 Participants |
| Binocular Computer Game Treatment Older Cohort | Frequency of Adverse Symptoms (Symptom Survey) at 8 Weeks | Look Over Spectacles | Sometimes | 9 Participants |
| Binocular Computer Game Treatment Older Cohort | Frequency of Adverse Symptoms (Symptom Survey) at 8 Weeks | Look Over Spectacles | Almost Never | 15 Participants |
| Binocular Computer Game Treatment Older Cohort | Frequency of Adverse Symptoms (Symptom Survey) at 8 Weeks | Blurred Vision | Often | 0 Participants |
| Binocular Computer Game Treatment Older Cohort | Frequency of Adverse Symptoms (Symptom Survey) at 8 Weeks | Take Off Spectacles | Almost Always | 1 Participants |
| Binocular Computer Game Treatment Older Cohort | Frequency of Adverse Symptoms (Symptom Survey) at 8 Weeks | Look Over Spectacles | Never | 42 Participants |
| Binocular Computer Game Treatment Older Cohort | Frequency of Adverse Symptoms (Symptom Survey) at 8 Weeks | Headache | Almost Always | 0 Participants |
| Binocular Computer Game Treatment Older Cohort | Frequency of Adverse Symptoms (Symptom Survey) at 8 Weeks | Blurred Vision | Almost Always | 0 Participants |
| Binocular Computer Game Treatment Older Cohort | Frequency of Adverse Symptoms (Symptom Survey) at 8 Weeks | Take Off Spectacles | Sometimes | 10 Participants |
| Binocular Computer Game Treatment Older Cohort | Frequency of Adverse Symptoms (Symptom Survey) at 8 Weeks | Headache | Often | 2 Participants |
| Binocular Computer Game Treatment Older Cohort | Frequency of Adverse Symptoms (Symptom Survey) at 8 Weeks | Headache | Sometimes | 8 Participants |
| Continued Spectacle Correction Older Cohort | Frequency of Adverse Symptoms (Symptom Survey) at 8 Weeks | Take Off Spectacles | Almost Always | 0 Participants |
| Continued Spectacle Correction Older Cohort | Frequency of Adverse Symptoms (Symptom Survey) at 8 Weeks | Blurred Vision | Never | 61 Participants |
| Continued Spectacle Correction Older Cohort | Frequency of Adverse Symptoms (Symptom Survey) at 8 Weeks | Blurred Vision | Almost Never | 4 Participants |
| Continued Spectacle Correction Older Cohort | Frequency of Adverse Symptoms (Symptom Survey) at 8 Weeks | Blurred Vision | Sometimes | 2 Participants |
| Continued Spectacle Correction Older Cohort | Frequency of Adverse Symptoms (Symptom Survey) at 8 Weeks | Blurred Vision | Often | 1 Participants |
| Continued Spectacle Correction Older Cohort | Frequency of Adverse Symptoms (Symptom Survey) at 8 Weeks | Blurred Vision | Almost Always | 0 Participants |
| Continued Spectacle Correction Older Cohort | Frequency of Adverse Symptoms (Symptom Survey) at 8 Weeks | Eyestrain | Never | 47 Participants |
| Continued Spectacle Correction Older Cohort | Frequency of Adverse Symptoms (Symptom Survey) at 8 Weeks | Eyestrain | Almost Never | 13 Participants |
| Continued Spectacle Correction Older Cohort | Frequency of Adverse Symptoms (Symptom Survey) at 8 Weeks | Eyestrain | Sometimes | 7 Participants |
| Continued Spectacle Correction Older Cohort | Frequency of Adverse Symptoms (Symptom Survey) at 8 Weeks | Eyestrain | Often | 1 Participants |
| Continued Spectacle Correction Older Cohort | Frequency of Adverse Symptoms (Symptom Survey) at 8 Weeks | Eyestrain | Almost Always | 0 Participants |
| Continued Spectacle Correction Older Cohort | Frequency of Adverse Symptoms (Symptom Survey) at 8 Weeks | Headache | Never | 44 Participants |
| Continued Spectacle Correction Older Cohort | Frequency of Adverse Symptoms (Symptom Survey) at 8 Weeks | Headache | Almost Never | 17 Participants |
| Continued Spectacle Correction Older Cohort | Frequency of Adverse Symptoms (Symptom Survey) at 8 Weeks | Headache | Sometimes | 6 Participants |
| Continued Spectacle Correction Older Cohort | Frequency of Adverse Symptoms (Symptom Survey) at 8 Weeks | Headache | Often | 1 Participants |
| Continued Spectacle Correction Older Cohort | Frequency of Adverse Symptoms (Symptom Survey) at 8 Weeks | Headache | Almost Always | 0 Participants |
| Continued Spectacle Correction Older Cohort | Frequency of Adverse Symptoms (Symptom Survey) at 8 Weeks | Look Over Spectacles | Never | 41 Participants |
| Continued Spectacle Correction Older Cohort | Frequency of Adverse Symptoms (Symptom Survey) at 8 Weeks | Look Over Spectacles | Almost Never | 11 Participants |
| Continued Spectacle Correction Older Cohort | Frequency of Adverse Symptoms (Symptom Survey) at 8 Weeks | Look Over Spectacles | Sometimes | 10 Participants |
| Continued Spectacle Correction Older Cohort | Frequency of Adverse Symptoms (Symptom Survey) at 8 Weeks | Look Over Spectacles | Often | 2 Participants |
| Continued Spectacle Correction Older Cohort | Frequency of Adverse Symptoms (Symptom Survey) at 8 Weeks | Look Over Spectacles | Almost Always | 1 Participants |
| Continued Spectacle Correction Older Cohort | Frequency of Adverse Symptoms (Symptom Survey) at 8 Weeks | Take Off Spectacles | Never | 43 Participants |
| Continued Spectacle Correction Older Cohort | Frequency of Adverse Symptoms (Symptom Survey) at 8 Weeks | Take Off Spectacles | Almost Never | 17 Participants |
| Continued Spectacle Correction Older Cohort | Frequency of Adverse Symptoms (Symptom Survey) at 8 Weeks | Take Off Spectacles | Sometimes | 4 Participants |
| Continued Spectacle Correction Older Cohort | Frequency of Adverse Symptoms (Symptom Survey) at 8 Weeks | Take Off Spectacles | Often | 1 Participants |
| Binocular Computer Game Treatment Younger Cohort | Frequency of Adverse Symptoms (Symptom Survey) at 8 Weeks | Blurred Vision | Often | 0 Participants |
| Binocular Computer Game Treatment Younger Cohort | Frequency of Adverse Symptoms (Symptom Survey) at 8 Weeks | Take Off Spectacles | Almost Never | 28 Participants |
| Binocular Computer Game Treatment Younger Cohort | Frequency of Adverse Symptoms (Symptom Survey) at 8 Weeks | Headache | Sometimes | 10 Participants |
| Binocular Computer Game Treatment Younger Cohort | Frequency of Adverse Symptoms (Symptom Survey) at 8 Weeks | Blurred Vision | Almost Always | 0 Participants |
| Binocular Computer Game Treatment Younger Cohort | Frequency of Adverse Symptoms (Symptom Survey) at 8 Weeks | Headache | Often | 1 Participants |
| Binocular Computer Game Treatment Younger Cohort | Frequency of Adverse Symptoms (Symptom Survey) at 8 Weeks | Blurred Vision | Never | 74 Participants |
| Binocular Computer Game Treatment Younger Cohort | Frequency of Adverse Symptoms (Symptom Survey) at 8 Weeks | Headache | Almost Always | 0 Participants |
| Binocular Computer Game Treatment Younger Cohort | Frequency of Adverse Symptoms (Symptom Survey) at 8 Weeks | Take Off Spectacles | Almost Always | 0 Participants |
| Binocular Computer Game Treatment Younger Cohort | Frequency of Adverse Symptoms (Symptom Survey) at 8 Weeks | Look Over Spectacles | Never | 38 Participants |
| Binocular Computer Game Treatment Younger Cohort | Frequency of Adverse Symptoms (Symptom Survey) at 8 Weeks | Take Off Spectacles | Sometimes | 8 Participants |
| Binocular Computer Game Treatment Younger Cohort | Frequency of Adverse Symptoms (Symptom Survey) at 8 Weeks | Look Over Spectacles | Almost Never | 16 Participants |
| Binocular Computer Game Treatment Younger Cohort | Frequency of Adverse Symptoms (Symptom Survey) at 8 Weeks | Blurred Vision | Sometimes | 7 Participants |
| Binocular Computer Game Treatment Younger Cohort | Frequency of Adverse Symptoms (Symptom Survey) at 8 Weeks | Look Over Spectacles | Sometimes | 26 Participants |
| Binocular Computer Game Treatment Younger Cohort | Frequency of Adverse Symptoms (Symptom Survey) at 8 Weeks | Look Over Spectacles | Often | 5 Participants |
| Binocular Computer Game Treatment Younger Cohort | Frequency of Adverse Symptoms (Symptom Survey) at 8 Weeks | Blurred Vision | Almost Never | 5 Participants |
| Binocular Computer Game Treatment Younger Cohort | Frequency of Adverse Symptoms (Symptom Survey) at 8 Weeks | Look Over Spectacles | Almost Always | 1 Participants |
| Binocular Computer Game Treatment Younger Cohort | Frequency of Adverse Symptoms (Symptom Survey) at 8 Weeks | Take Off Spectacles | Often | 5 Participants |
| Binocular Computer Game Treatment Younger Cohort | Frequency of Adverse Symptoms (Symptom Survey) at 8 Weeks | Eyestrain | Sometimes | 12 Participants |
| Binocular Computer Game Treatment Younger Cohort | Frequency of Adverse Symptoms (Symptom Survey) at 8 Weeks | Eyestrain | Almost Never | 16 Participants |
| Binocular Computer Game Treatment Younger Cohort | Frequency of Adverse Symptoms (Symptom Survey) at 8 Weeks | Take Off Spectacles | Never | 45 Participants |
| Binocular Computer Game Treatment Younger Cohort | Frequency of Adverse Symptoms (Symptom Survey) at 8 Weeks | Eyestrain | Almost Always | 0 Participants |
| Binocular Computer Game Treatment Younger Cohort | Frequency of Adverse Symptoms (Symptom Survey) at 8 Weeks | Eyestrain | Often | 0 Participants |
| Binocular Computer Game Treatment Younger Cohort | Frequency of Adverse Symptoms (Symptom Survey) at 8 Weeks | Headache | Never | 62 Participants |
| Binocular Computer Game Treatment Younger Cohort | Frequency of Adverse Symptoms (Symptom Survey) at 8 Weeks | Eyestrain | Never | 58 Participants |
| Binocular Computer Game Treatment Younger Cohort | Frequency of Adverse Symptoms (Symptom Survey) at 8 Weeks | Headache | Almost Never | 13 Participants |
| Continued Spectacle Correction Younger Cohort | Frequency of Adverse Symptoms (Symptom Survey) at 8 Weeks | Take Off Spectacles | Almost Always | 0 Participants |
| Continued Spectacle Correction Younger Cohort | Frequency of Adverse Symptoms (Symptom Survey) at 8 Weeks | Take Off Spectacles | Often | 3 Participants |
| Continued Spectacle Correction Younger Cohort | Frequency of Adverse Symptoms (Symptom Survey) at 8 Weeks | Look Over Spectacles | Often | 2 Participants |
| Continued Spectacle Correction Younger Cohort | Frequency of Adverse Symptoms (Symptom Survey) at 8 Weeks | Headache | Sometimes | 2 Participants |
| Continued Spectacle Correction Younger Cohort | Frequency of Adverse Symptoms (Symptom Survey) at 8 Weeks | Take Off Spectacles | Never | 44 Participants |
| Continued Spectacle Correction Younger Cohort | Frequency of Adverse Symptoms (Symptom Survey) at 8 Weeks | Take Off Spectacles | Almost Never | 30 Participants |
| Continued Spectacle Correction Younger Cohort | Frequency of Adverse Symptoms (Symptom Survey) at 8 Weeks | Blurred Vision | Never | 62 Participants |
| Continued Spectacle Correction Younger Cohort | Frequency of Adverse Symptoms (Symptom Survey) at 8 Weeks | Headache | Often | 0 Participants |
| Continued Spectacle Correction Younger Cohort | Frequency of Adverse Symptoms (Symptom Survey) at 8 Weeks | Blurred Vision | Often | 0 Participants |
| Continued Spectacle Correction Younger Cohort | Frequency of Adverse Symptoms (Symptom Survey) at 8 Weeks | Headache | Never | 65 Participants |
| Continued Spectacle Correction Younger Cohort | Frequency of Adverse Symptoms (Symptom Survey) at 8 Weeks | Look Over Spectacles | Almost Always | 2 Participants |
| Continued Spectacle Correction Younger Cohort | Frequency of Adverse Symptoms (Symptom Survey) at 8 Weeks | Headache | Almost Always | 0 Participants |
| Continued Spectacle Correction Younger Cohort | Frequency of Adverse Symptoms (Symptom Survey) at 8 Weeks | Blurred Vision | Almost Always | 0 Participants |
| Continued Spectacle Correction Younger Cohort | Frequency of Adverse Symptoms (Symptom Survey) at 8 Weeks | Eyestrain | Often | 0 Participants |
| Continued Spectacle Correction Younger Cohort | Frequency of Adverse Symptoms (Symptom Survey) at 8 Weeks | Eyestrain | Almost Never | 20 Participants |
| Continued Spectacle Correction Younger Cohort | Frequency of Adverse Symptoms (Symptom Survey) at 8 Weeks | Look Over Spectacles | Never | 40 Participants |
| Continued Spectacle Correction Younger Cohort | Frequency of Adverse Symptoms (Symptom Survey) at 8 Weeks | Blurred Vision | Sometimes | 5 Participants |
| Continued Spectacle Correction Younger Cohort | Frequency of Adverse Symptoms (Symptom Survey) at 8 Weeks | Eyestrain | Almost Always | 0 Participants |
| Continued Spectacle Correction Younger Cohort | Frequency of Adverse Symptoms (Symptom Survey) at 8 Weeks | Eyestrain | Never | 58 Participants |
| Continued Spectacle Correction Younger Cohort | Frequency of Adverse Symptoms (Symptom Survey) at 8 Weeks | Look Over Spectacles | Almost Never | 17 Participants |
| Continued Spectacle Correction Younger Cohort | Frequency of Adverse Symptoms (Symptom Survey) at 8 Weeks | Eyestrain | Sometimes | 6 Participants |
| Continued Spectacle Correction Younger Cohort | Frequency of Adverse Symptoms (Symptom Survey) at 8 Weeks | Take Off Spectacles | Sometimes | 7 Participants |
| Continued Spectacle Correction Younger Cohort | Frequency of Adverse Symptoms (Symptom Survey) at 8 Weeks | Headache | Almost Never | 17 Participants |
| Continued Spectacle Correction Younger Cohort | Frequency of Adverse Symptoms (Symptom Survey) at 8 Weeks | Look Over Spectacles | Sometimes | 23 Participants |
| Continued Spectacle Correction Younger Cohort | Frequency of Adverse Symptoms (Symptom Survey) at 8 Weeks | Blurred Vision | Almost Never | 17 Participants |
Secondary
Mean Change in Fellow Eye VA at 8 Weeks (Older Cohort)
The mean change in fellow-eye VA from baseline to 8 weeks will be calculated and compared between treatment groups using ANCOVA with adjustment for baseline VA.
Time frame: Baseline and 8 weeks
| Arm | Measure | Group | Value (MEAN) |
|---|---|---|---|
| Binocular Computer Game Treatment Older Cohort | Mean Change in Fellow Eye VA at 8 Weeks (Older Cohort) | Adjusted | 0.5 Letters |
| Binocular Computer Game Treatment Older Cohort | Mean Change in Fellow Eye VA at 8 Weeks (Older Cohort) | Unadjusted | 0.5 Letters |
| Continued Spectacle Correction Older Cohort | Mean Change in Fellow Eye VA at 8 Weeks (Older Cohort) | Adjusted | 1.5 Letters |
| Continued Spectacle Correction Older Cohort | Mean Change in Fellow Eye VA at 8 Weeks (Older Cohort) | Unadjusted | 1.5 Letters |
Comparison: An analysis of covariance (ANCOVA) model was used to compute the treatment group difference in the mean change in fellow-eye visual acuity (letters) from baseline to 8 weeks, adjusting for fellow-eye visual acuity at randomization. A 2-sided 99% confidence interval was computed on the adjusted treatment group difference.99% CI: [-2.3, 0.3]
Secondary
Mean Change in Fellow Eye VA at 8 Weeks (Younger Cohort)
The mean change in fellow-eye VA from baseline to 8 weeks will be calculated and compared between treatment groups using ANCOVA with adjustment for baseline VA.
Time frame: baseline and 8 weeks
| Arm | Measure | Group | Value (MEAN) |
|---|---|---|---|
| Binocular Computer Game Treatment Older Cohort | Mean Change in Fellow Eye VA at 8 Weeks (Younger Cohort) | Adjusted | 0.3160 logMAR Lines |
| Binocular Computer Game Treatment Older Cohort | Mean Change in Fellow Eye VA at 8 Weeks (Younger Cohort) | Unadjusted | 0.3256 logMAR Lines |
| Continued Spectacle Correction Older Cohort | Mean Change in Fellow Eye VA at 8 Weeks (Younger Cohort) | Unadjusted | 0.2024 logMAR Lines |
| Continued Spectacle Correction Older Cohort | Mean Change in Fellow Eye VA at 8 Weeks (Younger Cohort) | Adjusted | 0.2122 logMAR Lines |
Secondary
Mean Change in Fellow Eye Visual Acuity at 4 Weeks (Older Cohort)
The mean change in fellow-eye VA from baseline to 4 weeks will be calculated and compared between treatment groups using ANCOVA with adjustment for baseline VA.
Time frame: Baseline and 4 weeks
| Arm | Measure | Group | Value (MEAN) |
|---|---|---|---|
| Binocular Computer Game Treatment Older Cohort | Mean Change in Fellow Eye Visual Acuity at 4 Weeks (Older Cohort) | Adjusted | 0.1 Letters |
| Binocular Computer Game Treatment Older Cohort | Mean Change in Fellow Eye Visual Acuity at 4 Weeks (Older Cohort) | Unadjusted | 0.1 Letters |
| Continued Spectacle Correction Older Cohort | Mean Change in Fellow Eye Visual Acuity at 4 Weeks (Older Cohort) | Adjusted | 1.1 Letters |
| Continued Spectacle Correction Older Cohort | Mean Change in Fellow Eye Visual Acuity at 4 Weeks (Older Cohort) | Unadjusted | 1.1 Letters |
Comparison: An analysis of covariance (ANCOVA) model was used to compute the treatment group difference in the mean change in fellow-eye visual acuity (letters) from baseline to 4 weeks, adjusting for fellow-eye visual acuity at randomization. A 2-sided 99% confidence interval was computed on the adjusted treatment group difference.99% CI: [-2.5, 0.4]
Secondary
Mean Change in Fellow Eye Visual Acuity at 4 Weeks (Younger Cohort)
The mean change in fellow-eye VA from baseline to 4 weeks will be calculated and compared between treatment groups using ANCOVA with adjustment for baseline VA.
Time frame: Baseline and 4 weeks
| Arm | Measure | Group | Value (MEAN) |
|---|---|---|---|
| Binocular Computer Game Treatment Older Cohort | Mean Change in Fellow Eye Visual Acuity at 4 Weeks (Younger Cohort) | Adjusted | 0.0536 logMAR Lines |
| Binocular Computer Game Treatment Older Cohort | Mean Change in Fellow Eye Visual Acuity at 4 Weeks (Younger Cohort) | Unadjusted | 0.0682 logMAR Lines |
| Continued Spectacle Correction Older Cohort | Mean Change in Fellow Eye Visual Acuity at 4 Weeks (Younger Cohort) | Unadjusted | 0.1786 logMAR Lines |
| Continued Spectacle Correction Older Cohort | Mean Change in Fellow Eye Visual Acuity at 4 Weeks (Younger Cohort) | Adjusted | 0.1939 logMAR Lines |
Secondary
Ocular Alignment at 4 Weeks
The proportion of subjects with development of new strabismus (no heterotropia at baseline and the presence of near and/or distance heterotropia at 4 weeks) or an increase from baseline ≥10∆ in a pre-existing strabismus at 4 weeks will be reported by treatment group and compared using Barnard's exact test. Ocular alignment will be assessed in current refractive correction by the cover/uncover test, simultaneous prism and cover test (SPCT), and prism and alternate cover test (PACT) in primary gaze at distance (3 meters) and at near (1/3 meter). Participants were classified according to whether they met the any of the following criteria at the 4-week visit: development of a new tropia (measured by SPCT) and/or worsening of a pre-existing deviation by 10 prism diopters (pd) measured by SPCT.
Time frame: 4 weeks
Population: As this was a safety outcome, all visit information was recorded, regardless of whether or not it was collected in the analysis window.
| Arm | Measure | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|
| Binocular Computer Game Treatment Older Cohort | Ocular Alignment at 4 Weeks | 10 Participants |
| Continued Spectacle Correction Older Cohort | Ocular Alignment at 4 Weeks | 6 Participants |
| Binocular Computer Game Treatment Younger Cohort | Ocular Alignment at 4 Weeks | 7 Participants |
| Continued Spectacle Correction Younger Cohort | Ocular Alignment at 4 Weeks | 7 Participants |
Comparison: Fisher's exact test was used to perform the treatment group comparison of the proportion of participants who developed a new ocular deviation and/or worsening of a pre-existing ocular deviation by 10 prism diopters at the 4-week visit.p-value: 0.37Fisher Exact
Secondary
Ocular Alignment at 8 Weeks
The proportion of subjects with development of new strabismus (no heterotropia at baseline and the presence of near and/or distance heterotropia at 8 weeks) or an increase from baseline ≥10∆ in a pre-existing strabismus at 8 weeks will be reported by treatment group and compared using Barnard's exact test. Ocular alignment will be assessed in current refractive correction by the cover/uncover test, simultaneous prism and cover test (SPCT), and prism and alternate cover test (PACT) in primary gaze at distance (3 meters) and at near (1/3 meter). Participants were classified according to whether they met the any of the following criteria at the 8-week visit: development of a new tropia (measured by SPCT) and/or worsening of a pre-existing deviation by 10 prism diopters (pd) measured by SPCT.
Time frame: 8 weeks
Population: As this was a safety outcome, all visit information was recorded, regardless of whether or not it was collected in the analysis window.
| Arm | Measure | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|
| Binocular Computer Game Treatment Older Cohort | Ocular Alignment at 8 Weeks | 9 Participants |
| Continued Spectacle Correction Older Cohort | Ocular Alignment at 8 Weeks | 9 Participants |
| Binocular Computer Game Treatment Younger Cohort | Ocular Alignment at 8 Weeks | 6 Participants |
| Continued Spectacle Correction Younger Cohort | Ocular Alignment at 8 Weeks | 7 Participants |
Comparison: Fisher's exact test was used to perform the treatment group comparison of the proportion of participants who developed a new ocular deviation and/or worsening of a pre-existing ocular deviation by 10 prism diopters at the 8-week visit.p-value: 0.99Fisher Exact
Secondary
Treatment Compliance With Spectacle Wear
Parent-reported adherence with spectacle wear (excluding participants with reported compliance of 'N/A') for the initial 4 weeks. Patient reported to have completed \>75% of spectacle wear at 4 weeks.
Time frame: 4 weeks
| Arm | Measure | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|
| Binocular Computer Game Treatment Older Cohort | Treatment Compliance With Spectacle Wear | 57 Participants |
| Continued Spectacle Correction Older Cohort | Treatment Compliance With Spectacle Wear | 57 Participants |
| Binocular Computer Game Treatment Younger Cohort | Treatment Compliance With Spectacle Wear | 66 Participants |
| Continued Spectacle Correction Younger Cohort | Treatment Compliance With Spectacle Wear | 74 Participants |
Secondary
Treatment Compliance With Spectacle Wear
Parent-reported adherence with spectacle wear (excluding participants with reported compliance of 'N/A') across 8 weeks. Patient reported to have completed \>75% of spectacle wear at 8 weeks.
Time frame: 8 weeks
| Arm | Measure | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|
| Binocular Computer Game Treatment Older Cohort | Treatment Compliance With Spectacle Wear | 61 Participants |
| Continued Spectacle Correction Older Cohort | Treatment Compliance With Spectacle Wear | 62 Participants |
| Binocular Computer Game Treatment Younger Cohort | Treatment Compliance With Spectacle Wear | 69 Participants |
| Continued Spectacle Correction Younger Cohort | Treatment Compliance With Spectacle Wear | 78 Participants |
Secondary
VA Improvement at 4 Weeks Defined as a Binary Outcome
A secondary analysis will estimate the proportion of subjects with amblyopic-eye VA improvement of ≥ 2 logMAR lines (≥ 10 letters if E-ETDRS) at 4 weeks after baseline.
Time frame: At 4 weeks
| Arm | Measure | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|
| Binocular Computer Game Treatment Older Cohort | VA Improvement at 4 Weeks Defined as a Binary Outcome | 2 Participants |
| Continued Spectacle Correction Older Cohort | VA Improvement at 4 Weeks Defined as a Binary Outcome | 3 Participants |
| Binocular Computer Game Treatment Younger Cohort | VA Improvement at 4 Weeks Defined as a Binary Outcome | 31 Participants |
| Continued Spectacle Correction Younger Cohort | VA Improvement at 4 Weeks Defined as a Binary Outcome | 16 Participants |
Comparison: Binomial regression was used for the treatment group comparison of the proportion of participants classified as improving 2 or more logMAR lines (10 or more letters if E-ETDRS) from baseline at the 4-week visit, adjusted for visual acuity at randomization.98.3% CI: [-13, 9]
Secondary
VA Improvement at 8 Weeks Defined as a Binary Outcome
A secondary analysis will estimate the proportion of subjects with amblyopic-eye VA improvement of ≥ 2 logMAR lines (≥ 10 letters if E-ETDRS) at 8 weeks after baseline.
Time frame: At 8 weeks
Population: Of 68 participants in the continued spectacle correction older cohort, only 67 visits were completed in the analysis window.
| Arm | Measure | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|
| Binocular Computer Game Treatment Older Cohort | VA Improvement at 8 Weeks Defined as a Binary Outcome | 5 Participants |
| Continued Spectacle Correction Older Cohort | VA Improvement at 8 Weeks Defined as a Binary Outcome | 6 Participants |
| Binocular Computer Game Treatment Younger Cohort | VA Improvement at 8 Weeks Defined as a Binary Outcome | 35 Participants |
| Continued Spectacle Correction Younger Cohort | VA Improvement at 8 Weeks Defined as a Binary Outcome | 25 Participants |
Comparison: Binomial regression was used for the treatment group comparison of the proportion of participants classified as improving 2 or more logMAR lines (10 or more letters if E-ETDRS) from baseline at the 8-week visit, adjusted for visual acuity at randomization.98.3% CI: [-15, 12]
Other Pre-specified
Exploratory Analysis: Subgroup VA Change Analysis at 4 Weeks
The treatment effect after 4 weeks in subgroups based on baseline factors will be assessed in exploratory analyses and used to suggest hypotheses for further investigation in future studies. The following baseline factors are of interest: amblyopic-eye VA, stereoacuity, the presence of a tropia at near, and prior amblyopia treatment (other than spectacle correction). In accordance with NIH guidelines, subgroup analyses of treatment effect according to gender and race/ethnicity will be conducted. Positive values for visual acuity change indicate improvement.
Time frame: Baseline and 4 weeks
Population: Analyses were limited to participants who completed the 4-week visit within the pre-defined analysis window (21 to \<49 days after randomization).
| Arm | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| Binocular Computer Game Treatment Older Cohort | Exploratory Analysis: Subgroup VA Change Analysis at 4 Weeks | Baseline VA: 20/040 | -1.7 Letters | Standard Deviation 5.9 |
| Binocular Computer Game Treatment Older Cohort | Exploratory Analysis: Subgroup VA Change Analysis at 4 Weeks | Baseline VA: 20/050 | 1.6 Letters | Standard Deviation 4.2 |
| Binocular Computer Game Treatment Older Cohort | Exploratory Analysis: Subgroup VA Change Analysis at 4 Weeks | Baseline VA: 20/080 to 20/200 | 3.2 Letters | Standard Deviation 5.9 |
| Binocular Computer Game Treatment Older Cohort | Exploratory Analysis: Subgroup VA Change Analysis at 4 Weeks | Near Heterotropia at Randomization: Yes | 0.1 Letters | Standard Deviation 5.4 |
| Binocular Computer Game Treatment Older Cohort | Exploratory Analysis: Subgroup VA Change Analysis at 4 Weeks | Near Heterotropia at Randomization: No | 2.0 Letters | Standard Deviation 5.2 |
| Binocular Computer Game Treatment Older Cohort | Exploratory Analysis: Subgroup VA Change Analysis at 4 Weeks | Race: White/Non-Hispanic | 0.9 Letters | Standard Deviation 4.6 |
| Binocular Computer Game Treatment Older Cohort | Exploratory Analysis: Subgroup VA Change Analysis at 4 Weeks | Race: Non-white/Hispanic | 2.5 Letters | Standard Deviation 6.8 |
| Binocular Computer Game Treatment Older Cohort | Exploratory Analysis: Subgroup VA Change Analysis at 4 Weeks | Age at Randomization: 7 to <10 | 1.6 Letters | Standard Deviation 6 |
| Binocular Computer Game Treatment Older Cohort | Exploratory Analysis: Subgroup VA Change Analysis at 4 Weeks | Overall | 1.3 Letters | Standard Deviation 5.3 |
| Binocular Computer Game Treatment Older Cohort | Exploratory Analysis: Subgroup VA Change Analysis at 4 Weeks | Baseline VA: 20/063 | 1.5 Letters | Standard Deviation 3.7 |
| Binocular Computer Game Treatment Older Cohort | Exploratory Analysis: Subgroup VA Change Analysis at 4 Weeks | Age at Randomization: 10 to <13 | 0.9 Letters | Standard Deviation 3.8 |
| Binocular Computer Game Treatment Older Cohort | Exploratory Analysis: Subgroup VA Change Analysis at 4 Weeks | Prior Binocular Treatment: Yes | 3.0 Letters | Standard Deviation 0 |
| Binocular Computer Game Treatment Older Cohort | Exploratory Analysis: Subgroup VA Change Analysis at 4 Weeks | Sex: Female | 1.5 Letters | Standard Deviation 4.6 |
| Binocular Computer Game Treatment Older Cohort | Exploratory Analysis: Subgroup VA Change Analysis at 4 Weeks | Baseline stereoacuity at near: Nil | 1.6 Letters | Standard Deviation 5.5 |
| Binocular Computer Game Treatment Older Cohort | Exploratory Analysis: Subgroup VA Change Analysis at 4 Weeks | Prior Binocular Treatment: No | 1.3 Letters | Standard Deviation 5.3 |
| Binocular Computer Game Treatment Older Cohort | Exploratory Analysis: Subgroup VA Change Analysis at 4 Weeks | Prior Amblyopia Treatment: Yes | 1.4 Letters | Standard Deviation 5.4 |
| Binocular Computer Game Treatment Older Cohort | Exploratory Analysis: Subgroup VA Change Analysis at 4 Weeks | Sex: Male | 1.2 Letters | Standard Deviation 5.8 |
| Binocular Computer Game Treatment Older Cohort | Exploratory Analysis: Subgroup VA Change Analysis at 4 Weeks | Baseline stereoacuity at near: Better than Nil | 1.1 Letters | Standard Deviation 5.2 |
| Binocular Computer Game Treatment Older Cohort | Exploratory Analysis: Subgroup VA Change Analysis at 4 Weeks | Prior Amblyopia Treatment: No | 0.5 Letters | Standard Deviation 3 |
| Continued Spectacle Correction Older Cohort | Exploratory Analysis: Subgroup VA Change Analysis at 4 Weeks | Prior Binocular Treatment: Yes | -5.8 Letters | Standard Deviation 3.1 |
| Continued Spectacle Correction Older Cohort | Exploratory Analysis: Subgroup VA Change Analysis at 4 Weeks | Baseline VA: 20/080 to 20/200 | 1.3 Letters | Standard Deviation 6.5 |
| Continued Spectacle Correction Older Cohort | Exploratory Analysis: Subgroup VA Change Analysis at 4 Weeks | Prior Binocular Treatment: No | 2.2 Letters | Standard Deviation 5.2 |
| Continued Spectacle Correction Older Cohort | Exploratory Analysis: Subgroup VA Change Analysis at 4 Weeks | Near Heterotropia at Randomization: No | 2.2 Letters | Standard Deviation 5.6 |
| Continued Spectacle Correction Older Cohort | Exploratory Analysis: Subgroup VA Change Analysis at 4 Weeks | Overall | 1.7 Letters | Standard Deviation 5.5 |
| Continued Spectacle Correction Older Cohort | Exploratory Analysis: Subgroup VA Change Analysis at 4 Weeks | Sex: Female | 1.8 Letters | Standard Deviation 6 |
| Continued Spectacle Correction Older Cohort | Exploratory Analysis: Subgroup VA Change Analysis at 4 Weeks | Sex: Male | 1.6 Letters | Standard Deviation 4.9 |
| Continued Spectacle Correction Older Cohort | Exploratory Analysis: Subgroup VA Change Analysis at 4 Weeks | Near Heterotropia at Randomization: Yes | 0.7 Letters | Standard Deviation 5.1 |
| Continued Spectacle Correction Older Cohort | Exploratory Analysis: Subgroup VA Change Analysis at 4 Weeks | Age at Randomization: 7 to <10 | 2.0 Letters | Standard Deviation 5.4 |
| Continued Spectacle Correction Older Cohort | Exploratory Analysis: Subgroup VA Change Analysis at 4 Weeks | Age at Randomization: 10 to <13 | 1.2 Letters | Standard Deviation 5.6 |
| Continued Spectacle Correction Older Cohort | Exploratory Analysis: Subgroup VA Change Analysis at 4 Weeks | Race: Non-white/Hispanic | 3.7 Letters | Standard Deviation 7.2 |
| Continued Spectacle Correction Older Cohort | Exploratory Analysis: Subgroup VA Change Analysis at 4 Weeks | Race: White/Non-Hispanic | 1.2 Letters | Standard Deviation 4.8 |
| Continued Spectacle Correction Older Cohort | Exploratory Analysis: Subgroup VA Change Analysis at 4 Weeks | Baseline VA: 20/063 | 2.5 Letters | Standard Deviation 5.5 |
| Continued Spectacle Correction Older Cohort | Exploratory Analysis: Subgroup VA Change Analysis at 4 Weeks | Baseline VA: 20/050 | 0.9 Letters | Standard Deviation 3.3 |
| Continued Spectacle Correction Older Cohort | Exploratory Analysis: Subgroup VA Change Analysis at 4 Weeks | Baseline VA: 20/040 | 2.2 Letters | Standard Deviation 4.5 |
| Continued Spectacle Correction Older Cohort | Exploratory Analysis: Subgroup VA Change Analysis at 4 Weeks | Prior Amblyopia Treatment: No | 5.0 Letters | Standard Deviation 5.7 |
| Continued Spectacle Correction Older Cohort | Exploratory Analysis: Subgroup VA Change Analysis at 4 Weeks | Prior Amblyopia Treatment: Yes | 1.6 Letters | Standard Deviation 5.5 |
| Continued Spectacle Correction Older Cohort | Exploratory Analysis: Subgroup VA Change Analysis at 4 Weeks | Baseline stereoacuity at near: Nil | 0.7 Letters | Standard Deviation 5.6 |
| Continued Spectacle Correction Older Cohort | Exploratory Analysis: Subgroup VA Change Analysis at 4 Weeks | Baseline stereoacuity at near: Better than Nil | 2.5 Letters | Standard Deviation 5.2 |
| Binocular Computer Game Treatment Younger Cohort | Exploratory Analysis: Subgroup VA Change Analysis at 4 Weeks | Baseline VA: 20/050 | 1.4 Letters | Standard Deviation 1.5 |
| Binocular Computer Game Treatment Younger Cohort | Exploratory Analysis: Subgroup VA Change Analysis at 4 Weeks | Baseline stereoacuity at near: Nil | 0.9 Letters | Standard Deviation 1.6 |
| Binocular Computer Game Treatment Younger Cohort | Exploratory Analysis: Subgroup VA Change Analysis at 4 Weeks | Baseline stereoacuity at near: Better than Nil | 1.2 Letters | Standard Deviation 1.4 |
| Binocular Computer Game Treatment Younger Cohort | Exploratory Analysis: Subgroup VA Change Analysis at 4 Weeks | Prior Amblyopia Treatment: Yes | 1.2 Letters | Standard Deviation 1.6 |
| Binocular Computer Game Treatment Younger Cohort | Exploratory Analysis: Subgroup VA Change Analysis at 4 Weeks | Baseline VA: 20/063 | 0.9 Letters | Standard Deviation 1.5 |
| Binocular Computer Game Treatment Younger Cohort | Exploratory Analysis: Subgroup VA Change Analysis at 4 Weeks | Sex: Female | 1.2 Letters | Standard Deviation 1.4 |
| Binocular Computer Game Treatment Younger Cohort | Exploratory Analysis: Subgroup VA Change Analysis at 4 Weeks | Age at Randomization: 5 to <7 | 1.1 Letters | Standard Deviation 1.5 |
| Binocular Computer Game Treatment Younger Cohort | Exploratory Analysis: Subgroup VA Change Analysis at 4 Weeks | Near Heterotropia at Randomization: No | 1.1 Letters | Standard Deviation 1.5 |
| Binocular Computer Game Treatment Younger Cohort | Exploratory Analysis: Subgroup VA Change Analysis at 4 Weeks | Baseline VA: 20/040 | 1.1 Letters | Standard Deviation 1.5 |
| Binocular Computer Game Treatment Younger Cohort | Exploratory Analysis: Subgroup VA Change Analysis at 4 Weeks | Overall | 1.1 Letters | Standard Deviation 1.4 |
| Binocular Computer Game Treatment Younger Cohort | Exploratory Analysis: Subgroup VA Change Analysis at 4 Weeks | Baseline VA: 20/080 to 20/200 | 1.0 Letters | Standard Deviation 1.3 |
| Binocular Computer Game Treatment Younger Cohort | Exploratory Analysis: Subgroup VA Change Analysis at 4 Weeks | Sex: Male | 1.0 Letters | Standard Deviation 1.4 |
| Binocular Computer Game Treatment Younger Cohort | Exploratory Analysis: Subgroup VA Change Analysis at 4 Weeks | Race: Non-white/Hispanic | 1.1 Letters | Standard Deviation 1.3 |
| Binocular Computer Game Treatment Younger Cohort | Exploratory Analysis: Subgroup VA Change Analysis at 4 Weeks | Age at Randomization: 4 to <5 | 0.8 Letters | Standard Deviation 1.2 |
| Binocular Computer Game Treatment Younger Cohort | Exploratory Analysis: Subgroup VA Change Analysis at 4 Weeks | Near Heterotropia at Randomization: Yes | 1.1 Letters | Standard Deviation 1.2 |
| Binocular Computer Game Treatment Younger Cohort | Exploratory Analysis: Subgroup VA Change Analysis at 4 Weeks | Prior Amblyopia Treatment: No | 0.9 Letters | Standard Deviation 1.1 |
| Binocular Computer Game Treatment Younger Cohort | Exploratory Analysis: Subgroup VA Change Analysis at 4 Weeks | Race: White/Non-Hispanic | 1.1 Letters | Standard Deviation 1.5 |
| Continued Spectacle Correction Younger Cohort | Exploratory Analysis: Subgroup VA Change Analysis at 4 Weeks | Prior Amblyopia Treatment: No | 0.6 Letters | Standard Deviation 1.1 |
| Continued Spectacle Correction Younger Cohort | Exploratory Analysis: Subgroup VA Change Analysis at 4 Weeks | Near Heterotropia at Randomization: No | 0.7 Letters | Standard Deviation 1.3 |
| Continued Spectacle Correction Younger Cohort | Exploratory Analysis: Subgroup VA Change Analysis at 4 Weeks | Baseline VA: 20/080 to 20/200 | 0.7 Letters | Standard Deviation 1.4 |
| Continued Spectacle Correction Younger Cohort | Exploratory Analysis: Subgroup VA Change Analysis at 4 Weeks | Baseline stereoacuity at near: Nil | 0.3 Letters | Standard Deviation 1.2 |
| Continued Spectacle Correction Younger Cohort | Exploratory Analysis: Subgroup VA Change Analysis at 4 Weeks | Baseline VA: 20/050 | 0.5 Letters | Standard Deviation 1.1 |
| Continued Spectacle Correction Younger Cohort | Exploratory Analysis: Subgroup VA Change Analysis at 4 Weeks | Sex: Male | 0.5 Letters | Standard Deviation 1.1 |
| Continued Spectacle Correction Younger Cohort | Exploratory Analysis: Subgroup VA Change Analysis at 4 Weeks | Age at Randomization: 5 to <7 | 0.6 Letters | Standard Deviation 1.3 |
| Continued Spectacle Correction Younger Cohort | Exploratory Analysis: Subgroup VA Change Analysis at 4 Weeks | Baseline VA: 20/040 | 0.9 Letters | Standard Deviation 1.4 |
| Continued Spectacle Correction Younger Cohort | Exploratory Analysis: Subgroup VA Change Analysis at 4 Weeks | Race: White/Non-Hispanic | 0.6 Letters | Standard Deviation 1.3 |
| Continued Spectacle Correction Younger Cohort | Exploratory Analysis: Subgroup VA Change Analysis at 4 Weeks | Sex: Female | 0.7 Letters | Standard Deviation 1.4 |
| Continued Spectacle Correction Younger Cohort | Exploratory Analysis: Subgroup VA Change Analysis at 4 Weeks | Prior Amblyopia Treatment: Yes | 0.6 Letters | Standard Deviation 1.4 |
| Continued Spectacle Correction Younger Cohort | Exploratory Analysis: Subgroup VA Change Analysis at 4 Weeks | Age at Randomization: 4 to <5 | 0.8 Letters | Standard Deviation 1.2 |
| Continued Spectacle Correction Younger Cohort | Exploratory Analysis: Subgroup VA Change Analysis at 4 Weeks | Overall | 0.6 Letters | Standard Deviation 1.3 |
| Continued Spectacle Correction Younger Cohort | Exploratory Analysis: Subgroup VA Change Analysis at 4 Weeks | Near Heterotropia at Randomization: Yes | 0.4 Letters | Standard Deviation 1.3 |
| Continued Spectacle Correction Younger Cohort | Exploratory Analysis: Subgroup VA Change Analysis at 4 Weeks | Baseline VA: 20/063 | 0.5 Letters | Standard Deviation 1.2 |
| Continued Spectacle Correction Younger Cohort | Exploratory Analysis: Subgroup VA Change Analysis at 4 Weeks | Race: Non-white/Hispanic | 0.5 Letters | Standard Deviation 0.8 |
| Continued Spectacle Correction Younger Cohort | Exploratory Analysis: Subgroup VA Change Analysis at 4 Weeks | Baseline stereoacuity at near: Better than Nil | 0.8 Letters | Standard Deviation 1.3 |
Comparison: An analysis of covariance (ANCOVA) was performed to test the 2-way interaction between treatment group with each factor (baseline age and visual acuity were treated as continuous factors), adjusting for baseline amblyopic-eye visual acuity and the nested terms from the interaction term. Formal subgroup analyses were only performed if there was a minimum of 20 participants in every subgroup category across both treatment groups for factors treated as categorical variables in the model.p-value: >0.01ANCOVA