Intermittent Exotropia
Conditions
Keywords
Intermittent Exotropia, IXT, overminus
Brief summary
The main objectives of this randomized trial comparing overminus lens treatment to non-overminus (spectacles without overminus or spectacles with plano lenses) are to determine: * The long-term on-treatment effect of overminus treatment on distance intermittent exotropia (IXT) control score. * The off-treatment effect of overminus treatment on distance IXT control score (following weaning and 3 months off treatment).
Detailed description
The main objectives of this randomized trial comparing overminus lens treatment to non-overminus (spectacles without overminus or spectacles with plano lenses) are to determine: * The long-term on-treatment effect of overminus treatment on distance IXT control score. * The off-treatment effect of overminus treatment on distance IXT control score (following weaning and 3 months off treatment). The recently completed IXT3 pilot study (NCT02223650) addressed the question of whether overminus lens therapy has an initial short-term therapeutic effect for IXT while wearing overminus spectacles. There have been no rigorous studies that address the following important questions related to overminus lens therapy: * Does overminus lens therapy have a long-term therapeutic effect for IXT while wearing overminus spectacles (over many months or years)? * Does overminus lens therapy have a long-term therapeutic effect for IXT when overminus spectacles are discontinued? In November 2019, a protocol amendment discontinued overminus lens treatment and extended the study for an additional 18 months after the 18-month randomized trial has ended. The objective of the extension study is to compare long-term refractive error between subjects originally treated with either overminus spectacles or non-overminus spectacles as part of the 18-month randomized trial; treatment is at investigator discretion.
Interventions
DEVICEOverminus treatment
spectacles with full cycloplegic refraction plus 2.50 D overminus added to the sphere
DEVICENon-overminus treatment
spectacles with full cycloplegic refraction without overminus
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
3 Years to 10 Years
Healthy volunteers
No
Inclusion criteria
* Age 3 years to \< 11 years * Intermittent exotropia (manifest deviation) meeting all of the following criteria: * At distance: intermittent exotropia or constant exotropia o Mean distance control score of 2 points or more (mean of 3 assessments over the exam) * At near: intermittent exotropia, exophoria, or orthophoria o Subject cannot have a score of 5 points on all 3 near assessments of control * Exodeviation at least 15∆ at distance measured by PACT * Near deviation does not exceed distance deviation by more than 10∆ by PACT (convergence insufficiency type IXT excluded) * Distance visual acuity (any optotype method) in each eye of 0.4 logMAR (20/50) or better if age 3 years and 0.3 logMAR (20/40) or better if 4 years or older. * Interocular difference of distance visual acuity ≤0.2 logMAR (2 lines on a logMAR chart) * Refractive error between -6.00 diopters (D) standard error (SE) and +1.00D SE (inclusive) in the most myopic / least hyperopic eye based on a cycloplegic refraction performed within the past 2 months or at the end of the enrollment exam. * If refractive error (based on cycloplegic refraction performed within past 2 months or at the end of the enrollment exam) meets any of the following criteria, then pre-study spectacles are required and must have been worn for at least 1 week prior to enrollment: * SE anisometropia ≥1.00D * Astigmatism ≥1.50D in either eye * SE myopia ≥-1.00D in either eye Pre-study refractive correction, if worn, must meet the following criteria relative to the cycloplegic refraction performed within past 2 months or at the end of the enrollment exam: * SE anisometropia must be corrected within \<1.00D of the SE anisometropic difference * Astigmatism must be corrected within \<1.00D of full magnitude; axis must be within 10 degrees. * The SE of the spectacles must not meet the definition of substantial overminus (see
Exclusion criteria
below) * Gestational age ≥ 32 weeks * Birth weight \> 1500 grams * Parent understands the protocol and is willing to accept randomization to overminus spectacles or non-overminus spectacles * Parent has home phone (or access to phone) and is willing to be contacted by Jaeb Center staff and Investigator's site staff * Relocation outside of area of an active PEDIG site within next 18 months is not anticipated
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Mean Distance Control at 12-Months (On-Treatment Visit) | 12 months | A comparison of mean control of the distance exodeviation (average of 3 measurements over the exam) between the 2.50 diopters (D) overminus group and the non-overminus group (spectacles without overminus or no spectacles) at 12 months. The Office Control Score provides a rating of exodeviation control on a 0 to 5 scale, in subjects with intermittent exotropia. Scores 3 to 5 reflect the proportion of time a spontaneous manifest exotropia is present during 30 seconds of observation (\<50% score 3; \>50% score 4; 100% score 5). If no spontaneous manifest exotropia is observed, scores 0 to 2 reflect the longest time to regain fusion after three, 10-second dissociations (\>5 seconds score 2; 1-5 seconds score 1; \<1 second score 0). |
| Mean Distance Control at 18-Months (Off-Treatment Visit) | 18 months | A comparison of mean control of the distance exodeviation (average of 3 measurements over the exam) between the 2.50D overminus group and the non-overminus group (spectacles without overminus or no spectacles) at 18 months (after treatment discontinuation). The Office Control Score provides a rating of exodeviation control on a 0 to 5 scale, in subjects with intermittent exotropia. Scores 3 to 5 reflect the proportion of time a spontaneous manifest exotropia is present during 30 seconds of observation (\<50% score 3; \>50% score 4; 100% score 5). If no spontaneous manifest exotropia is observed, scores 0 to 2 reflect the longest time to regain fusion after three, 10-second dissociations (\>5 seconds score 2; 1-5 seconds score 1; \<1 second score 0). |
| Primary Outcome Measure Stratified by Sex | 12 months | NIH-required analysis. Primary outcome measure (stratified by sex): A comparison of mean control of the distance exodeviation (average of 3 measurements over the exam) between the 2.50 diopters (D) overminus group and the non-overminus group (spectacles without overminus or no spectacles) at 12 months. The Office Control Score provides a rating of exodeviation control on a 0 to 5 scale, in subjects with intermittent exotropia. Scores 3 to 5 reflect the proportion of time a spontaneous manifest exotropia is present during 30 seconds of observation (\<50% score 3; \>50% score 4; 100% score 5). If no spontaneous manifest exotropia is observed, scores 0 to 2 reflect the longest time to regain fusion after three, 10-second dissociations (\>5 seconds score 2; 1-5 seconds score 1; \<1 second score 0). |
| Primary Outcome Measure Stratified by Race | 12 months | NIH-required analysis. Primary outcome measure (stratified by race): A comparison of mean control of the distance exodeviation (average of 3 measurements over the exam) between the 2.50 diopters (D) overminus group and the non-overminus group (spectacles without overminus or no spectacles) at 12 months. The Office Control Score provides a rating of exodeviation control on a 0 to 5 scale, in subjects with intermittent exotropia. Scores 3 to 5 reflect the proportion of time a spontaneous manifest exotropia is present during 30 seconds of observation (\<50% score 3; \>50% score 4; 100% score 5). If no spontaneous manifest exotropia is observed, scores 0 to 2 reflect the longest time to regain fusion after three, 10-second dissociations (\>5 seconds score 2; 1-5 seconds score 1; \<1 second score 0). |
| Primary Outcome Measure Stratified by Ethnicity | 12 months | NIH-required analysis. Primary outcome measure (stratified by ethnicity): A comparison of mean control of the distance exodeviation (average of 3 measurements over the exam) between the 2.50 diopters (D) overminus group and the non-overminus group (spectacles without overminus or no spectacles) at 12 months. The Office Control Score provides a rating of exodeviation control on a 0 to 5 scale, in subjects with intermittent exotropia. Scores 3 to 5 reflect the proportion of time a spontaneous manifest exotropia is present during 30 seconds of observation (\<50% score 3; \>50% score 4; 100% score 5). If no spontaneous manifest exotropia is observed, scores 0 to 2 reflect the longest time to regain fusion after three, 10-second dissociations (\>5 seconds score 2; 1-5 seconds score 1; \<1 second score 0). |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Number of Participants With No Spontaneous Tropia | 12 months | The number of subjects with no spontaneous tropia at 12 months and at 18 months will be compared between treatment groups. |
| No Spontaneous Tropia | At 18 months | The proportion of subjects with no spontaneous tropia at 12 months and at 18 months will be compared between treatment groups. |
| Change in Distance Control | 12 months | The proportion of subjects with ≥1 point improvement in distance control between baseline and 12 months will be compared between treatment groups. The proportion of subjects with ≥2 points improvement in distance control will be similarly compared between treatment groups. The Office Control Score provides a rating of exodeviation control on a 0 to 5 scale, in subjects with intermittent exotropia. Scores 3 to 5 reflect the proportion of time a spontaneous manifest exotropia is present during 30 seconds of observation (\<50% score 3; \>50% score 4; 100% score 5). If no spontaneous manifest exotropia is observed, scores 0 to 2 reflect the longest time to regain fusion after three, 10-second dissociations (\>5 seconds score 2; 1-5 seconds score 1; \<1 second score 0). |
| Deterioration as Assessed by Motor Alignment and Stereoacuity at Near (12 Months) | 12 months | The cumulative proportion of subjects who meet deterioration criteria by the time point will be estimated for each treatment group. Participants who meet either of the following at any visit by a specific timepoint (e.g., 12 months, 18 months) will be considered to have met deterioration criteria by that timepoint. * Motor deterioration: Control of the exodeviation measures 5 (constant exotropia) on all three assessments at distance and near. The exodeviation does not need to be constant throughout the entire exam provided that it is constant during all three assessments of control. * Stereoacuity deterioration: Drop in near stereoacuity of at least 2 octaves from enrollment stereoacuity, or to nil, confirmed by a retest by a Masked Examiner on a subsequent day. Note: participants with nil stereoacuity at enrollment will not be able to deteriorate with respect to a drop in near stereoacuity. |
| Deterioration as Assessed by Motor Alignment and Stereoacuity at Near (18 Months) | 18 months | The cumulative proportion of subjects who meet deterioration criteria by the time point will be estimated for each treatment group. Participants who meet either of the following at any visit by a specific timepoint (e.g., 12 months, 18 months) will be considered to have met deterioration criteria by that timepoint. * Motor deterioration: Control of the exodeviation measures 5 (constant exotropia) on all three assessments at distance and near. The exodeviation does not need to be constant throughout the entire exam provided that it is constant during all three assessments of control. * Stereoacuity deterioration: Drop in near stereoacuity of at least 2 octaves from enrollment stereoacuity, or to nil, confirmed by a retest by a Masked Examiner on a subsequent day. Note: participants with nil stereoacuity at enrollment will not be able to deteriorate with respect to a drop in near stereoacuity. |
| Near Control (12 Months) | 12 months | Mean control of the near exodeviation (average of 3 measurements over the exam). The Office Control Score provides a rating of exodeviation control on a 0 to 5 scale, in subjects with intermittent exotropia. Scores 3 to 5 reflect the proportion of time a spontaneous manifest exotropia is present during 30 seconds of observation (\<50% score 3; \>50% score 4; 100% score 5). If no spontaneous manifest exotropia is observed, scores 0 to 2 reflect the longest time to regain fusion after three, 10-second dissociations (\>5 seconds score 2; 1-5 seconds score 1; \<1 second score 0). |
| Near Control (18 Months) | 18 months | Mean control of the near exodeviation (average of 3 measurements over the exam). The Office Control Score provides a rating of exodeviation control on a 0 to 5 scale, in subjects with intermittent exotropia. Scores 3 to 5 reflect the proportion of time a spontaneous manifest exotropia is present during 30 seconds of observation (\<50% score 3; \>50% score 4; 100% score 5). If no spontaneous manifest exotropia is observed, scores 0 to 2 reflect the longest time to regain fusion after three, 10-second dissociations (\>5 seconds score 2; 1-5 seconds score 1; \<1 second score 0). |
| Change in Near Control (12 Months) | 12 months | For each timepoint, the change in near control since baseline will be reported. The Office Control Score provides a rating of exodeviation control on a 0 to 5 scale, in subjects with intermittent exotropia. Scores 3 to 5 reflect the proportion of time a spontaneous manifest exotropia is present during 30 seconds of observation (\<50% score 3; \>50% score 4; 100% score 5). If no spontaneous manifest exotropia is observed, scores 0 to 2 reflect the longest time to regain fusion after three, 10-second dissociations (\>5 seconds score 2; 1-5 seconds score 1; \<1 second score 0). |
| Change in Near Control (18 Months) | 18 months | For each timepoint, the change in near control since baseline will be reported. The Office Control Score provides a rating of exodeviation control on a 0 to 5 scale, in subjects with intermittent exotropia. Scores 3 to 5 reflect the proportion of time a spontaneous manifest exotropia is present during 30 seconds of observation (\<50% score 3; \>50% score 4; 100% score 5). If no spontaneous manifest exotropia is observed, scores 0 to 2 reflect the longest time to regain fusion after three, 10-second dissociations (\>5 seconds score 2; 1-5 seconds score 1; \<1 second score 0). |
| Angle Magnitude (12 Months) | 12 months | The magnitude of the deviation by Prism Alternate Cover Test (PACT) will be compared between treatment groups. |
| Angle Magnitude (18 Months) | 18 months | The magnitude of the deviation by Prism Alternate Cover Test (PACT) will be compared between treatment groups. |
| Stereoacuity at 12 Months | 12 months | A comparison of near stereoacuity will be assessed using the Randot Preschool stereotest at near (performed at 40 cm) between treatment groups. |
| Stereoacuity at 18 Months | 18 months | A comparison of near stereoacuity will be assessed using the Randot Preschool stereotest at near (performed at 40 cm) between treatment groups. |
| Compliance With Spectacle Wear (12 Months) | 12 months | Compliance with spectacle wear will be assessed at the 12-month and 18-month outcome exam. Parents will give an estimate of the proportion of the time their children wore their spectacles. Proportion of time worn will be described as excellent (76% to 100%), good (51% to 75%), fair (26% to 50%), or poor (≤ 25%). The distribution of compliance will be assessed for each treatment group at the outcome exam. |
| Compliance With Spectacle Wear (18 Months) | 18 months | Compliance with spectacle wear will be assessed at the 12-month and 18-month outcome exam. Parents will give an estimate of the proportion of the time their children wore their spectacles. Proportion of time worn will be described as excellent (76% to 100%), good (51% to 75%), fair (26% to 50%), or poor (≤ 25%). The distribution of compliance will be assessed for each treatment group at the outcome exam. |
| Parent Symptom Survey [12 Months] | At 12 months | A brief survey of symptoms that may be associated with overminus such as headaches, eye strain, and problems with spectacle wear will be administered to the parents of the subjects. Parents are asked to respond to the survey questions based on their observations of their child in the past 2 weeks. Response options are based on frequency of observations; never, rarely, sometimes, often, always, and not applicable. |
| Parent Symptom Survey [18 Months] | At 18 months | A brief survey of symptoms that may be associated with overminus such as headaches, eye strain, and problems with spectacle wear will be administered to the parents of the subjects. Parents are asked to respond to the survey questions based on their observations of their child in the past 2 weeks. Response options are based on frequency of observations; never, rarely, sometimes, often, always, and not applicable. |
Countries
Canada, United States
Contacts
STUDY_CHAIRAngela M Chen, OD, MS
Marshall B. Ketchum University
STUDY_CHAIRS. Ayse Erzurum, MD
Eye Care Associates, Inc.
Participant flow
Participants by arm
| Arm | Count |
|---|---|
| Overminus Treatment spectacles with full cycloplegic refraction plus 2.50 D overminus added to the sphere
Overminus treatment: spectacles with full cycloplegic refraction plus 2.50 D overminus added to the sphere | 196 |
| Non-overminus Treatment spectacles with full cycloplegic refraction without overminus
Non-overminus treatment: spectacles with full cycloplegic refraction without overminus | 190 |
| Total | 386 |
Baseline characteristics
| Characteristic | Overminus Treatment | Total | Non-overminus Treatment |
|---|---|---|---|
| Age, Customized 3 to <7 years | 123 Participants | 243 Participants | 120 Participants |
| Age, Customized 7 to <11 years | 73 Participants | 143 Participants | 70 Participants |
| Exotropia Control at Distance 0 to <1 points | NA Participants | NA Participants | NA Participants |
| Exotropia Control at Distance 1 to <2 points | NA Participants | NA Participants | NA Participants |
| Exotropia Control at Distance 2 to <3 points | 84 Participants | 162 Participants | 78 Participants |
| Exotropia Control at Distance 3 to <4 points | 56 Participants | 108 Participants | 52 Participants |
| Exotropia Control at Distance 4 to 5 points | 56 Participants | 116 Participants | 60 Participants |
| Exotropia Control at near 0 to <1 points | 37 Participants | 83 Participants | 46 Participants |
| Exotropia Control at near 1 to <2 points | 80 Participants | 145 Participants | 65 Participants |
| Exotropia Control at near 2 to <3 points | 39 Participants | 83 Participants | 44 Participants |
| Exotropia Control at near 3 to <4 points | 31 Participants | 58 Participants | 27 Participants |
| Exotropia Control at near 4 to 5 points | 9 Participants | 17 Participants | 8 Participants |
| IOD of distance visual acuity 0.1 lines | 57 Participants | 118 Participants | 61 Participants |
| IOD of distance visual acuity 0.2 lines | 9 Participants | 23 Participants | 14 Participants |
| IOD of distance visual acuity 0 lines | 130 Participants | 245 Participants | 115 Participants |
| Mean distance visual acuity 20/12 to 20/20 | 115 Participants | 227 Participants | 112 Participants |
| Mean distance visual acuity 20/25 to 20/32 | 70 Participants | 139 Participants | 69 Participants |
| Mean distance visual acuity 20/40 to 20/50 | 11 Participants | 20 Participants | 9 Participants |
| PACT exodeviation at distance 10-15 Δ | 5 Participants | 11 Participants | 6 Participants |
| PACT exodeviation at distance 16-18 Δ | 42 Participants | 64 Participants | 22 Participants |
| PACT exodeviation at distance 19-25 Δ | 86 Participants | 177 Participants | 91 Participants |
| PACT exodeviation at distance 1-9 Δ | NA Participants | NA Participants | NA Participants |
| PACT exodeviation at distance 30-35 Δ | 54 Participants | 104 Participants | 50 Participants |
| PACT exodeviation at distance 40-45 Δ | 9 Participants | 28 Participants | 19 Participants |
| PACT exodeviation at distance >= 50 Δ | 0 Participants | 2 Participants | 2 Participants |
| PACT exodeviation at distance Esodeviation | NA Participants | NA Participants | NA Participants |
| PACT exodeviation at distance No exodeviation (orthophoria) | NA Participants | NA Participants | NA Participants |
| PACT Exodeviation at near 10-15 Δ | 45 Participants | 90 Participants | 45 Participants |
| PACT Exodeviation at near 16-18 Δ | 36 Participants | 65 Participants | 29 Participants |
| PACT Exodeviation at near 19-25 Δ | 57 Participants | 116 Participants | 59 Participants |
| PACT Exodeviation at near 1-9 Δ | 27 Participants | 51 Participants | 24 Participants |
| PACT Exodeviation at near 30-35 Δ | 24 Participants | 45 Participants | 21 Participants |
| PACT Exodeviation at near 40-45 Δ | 4 Participants | 12 Participants | 8 Participants |
| PACT Exodeviation at near >= 50 Δ | 1 Participants | 1 Participants | 0 Participants |
| PACT Exodeviation at near Esodeviation | 0 Participants | 1 Participants | 1 Participants |
| PACT Exodeviation at near No Exodeviation (orthophoria) | 2 Participants | 5 Participants | 3 Participants |
| Prior Non Surgical Treatment of IXT None | 126 Participants | 263 Participants | 137 Participants |
| Prior Non Surgical Treatment of IXT Other | 3 Participants | 6 Participants | 3 Participants |
| Prior Non Surgical Treatment of IXT Patching only | 53 Participants | 86 Participants | 33 Participants |
| Prior Non Surgical Treatment of IXT Patching plus other | 4 Participants | 10 Participants | 6 Participants |
| Prior Non Surgical Treatment of IXT Vision therapy only | 10 Participants | 21 Participants | 11 Participants |
| Race/Ethnicity, Customized Race/Ethnicity Asian | 6 Participants | 16 Participants | 10 Participants |
| Race/Ethnicity, Customized Race/Ethnicity Black/African American | 34 Participants | 62 Participants | 28 Participants |
| Race/Ethnicity, Customized Race/Ethnicity Hispanic | 31 Participants | 71 Participants | 40 Participants |
| Race/Ethnicity, Customized Race/Ethnicity Other | 12 Participants | 33 Participants | 21 Participants |
| Race/Ethnicity, Customized Race/Ethnicity White | 113 Participants | 204 Participants | 91 Participants |
| Randot Preschool Stereoacuity test score at near 200-800 arcseconds | 52 Participants | 107 Participants | 55 Participants |
| Randot Preschool Stereoacuity test score at near 40-100 arcseconds | 120 Participants | 232 Participants | 112 Participants |
| Randot Preschool Stereoacuity test score at near Nil | 16 Participants | 32 Participants | 16 Participants |
| Refractive Error >0.50 Diopters | 58 Participants | 117 Participants | 59 Participants |
| Refractive Error >-0.75 to 0.50 Diopters | 101 Participants | 197 Participants | 96 Participants |
| Refractive Error -0.75 to >-3.00 Diopters | 29 Participants | 61 Participants | 32 Participants |
| Refractive Error <=-3.00 Diopters | 8 Participants | 11 Participants | 3 Participants |
| Sex: Female, Male Female | 112 Participants | 226 Participants | 114 Participants |
| Sex: Female, Male Male | 84 Participants | 160 Participants | 76 Participants |
| Spectacle wear Does not wear spectacles | 140 Participants | 282 Participants | 142 Participants |
| Spectacle wear Wearing spectacles for at least 1 week | 56 Participants | 104 Participants | 48 Participants |
Adverse events
| Event type | EG000 affected / at risk | EG001 affected / at risk |
|---|---|---|
| deaths Total, all-cause mortality | 0 / 196 | 0 / 190 |
| other Total, other adverse events | 47 / 196 | 15 / 190 |
| serious Total, serious adverse events | 0 / 196 | 0 / 190 |
Outcome results
Primary
Mean Distance Control at 12-Months (On-Treatment Visit)
A comparison of mean control of the distance exodeviation (average of 3 measurements over the exam) between the 2.50 diopters (D) overminus group and the non-overminus group (spectacles without overminus or no spectacles) at 12 months. The Office Control Score provides a rating of exodeviation control on a 0 to 5 scale, in subjects with intermittent exotropia. Scores 3 to 5 reflect the proportion of time a spontaneous manifest exotropia is present during 30 seconds of observation (\<50% score 3; \>50% score 4; 100% score 5). If no spontaneous manifest exotropia is observed, scores 0 to 2 reflect the longest time to regain fusion after three, 10-second dissociations (\>5 seconds score 2; 1-5 seconds score 1; \<1 second score 0).
Time frame: 12 months
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| Overminus Treatment | Mean Distance Control at 12-Months (On-Treatment Visit) | 1.8 points | Standard Deviation 1.3 |
| Non-overminus Treatment | Mean Distance Control at 12-Months (On-Treatment Visit) | 2.8 points | Standard Deviation 1.5 |
Primary
Mean Distance Control at 18-Months (Off-Treatment Visit)
A comparison of mean control of the distance exodeviation (average of 3 measurements over the exam) between the 2.50D overminus group and the non-overminus group (spectacles without overminus or no spectacles) at 18 months (after treatment discontinuation). The Office Control Score provides a rating of exodeviation control on a 0 to 5 scale, in subjects with intermittent exotropia. Scores 3 to 5 reflect the proportion of time a spontaneous manifest exotropia is present during 30 seconds of observation (\<50% score 3; \>50% score 4; 100% score 5). If no spontaneous manifest exotropia is observed, scores 0 to 2 reflect the longest time to regain fusion after three, 10-second dissociations (\>5 seconds score 2; 1-5 seconds score 1; \<1 second score 0).
Time frame: 18 months
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| Overminus Treatment | Mean Distance Control at 18-Months (Off-Treatment Visit) | 2.4 points | Standard Deviation 1.5 |
| Non-overminus Treatment | Mean Distance Control at 18-Months (Off-Treatment Visit) | 2.7 points | Standard Deviation 1.6 |
Secondary
Angle Magnitude (12 Months)
The magnitude of the deviation by Prism Alternate Cover Test (PACT) will be compared between treatment groups.
Time frame: 12 months
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| Overminus Treatment | Angle Magnitude (12 Months) | 20.0 Prism Diopters | Standard Deviation 9 |
| Non-overminus Treatment | Angle Magnitude (12 Months) | 25.0 Prism Diopters | Standard Deviation 8 |
Secondary
Angle Magnitude (18 Months)
The magnitude of the deviation by Prism Alternate Cover Test (PACT) will be compared between treatment groups.
Time frame: 18 months
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| Overminus Treatment | Angle Magnitude (18 Months) | 23.0 Prism Diopters | Standard Deviation 9 |
| Non-overminus Treatment | Angle Magnitude (18 Months) | 24.0 Prism Diopters | Standard Deviation 11 |
Secondary
Change in Distance Control
The proportion of subjects with ≥1 point improvement in distance control between baseline and 12 months will be compared between treatment groups. The proportion of subjects with ≥2 points improvement in distance control will be similarly compared between treatment groups. The Office Control Score provides a rating of exodeviation control on a 0 to 5 scale, in subjects with intermittent exotropia. Scores 3 to 5 reflect the proportion of time a spontaneous manifest exotropia is present during 30 seconds of observation (\<50% score 3; \>50% score 4; 100% score 5). If no spontaneous manifest exotropia is observed, scores 0 to 2 reflect the longest time to regain fusion after three, 10-second dissociations (\>5 seconds score 2; 1-5 seconds score 1; \<1 second score 0).
Time frame: 12 months
| Arm | Measure | Group | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|---|
| Overminus Treatment | Change in Distance Control | >1 Point | 116 Participants |
| Overminus Treatment | Change in Distance Control | >2 Points | 65 Participants |
| Non-overminus Treatment | Change in Distance Control | >1 Point | 71 Participants |
| Non-overminus Treatment | Change in Distance Control | >2 Points | 24 Participants |
Comparison: \>1 point analysis95% CI: [7, 29]
95% CI: [10, 28]
Secondary
Change in Distance Control
The proportion of subjects with ≥1 point improvement in distance control between baseline and 18 months will be compared between treatment groups. The proportion of subjects with ≥2 points improvement in distance control will be similarly compared between treatment groups. The Office Control Score provides a rating of exodeviation control on a 0 to 5 scale, in subjects with intermittent exotropia. Scores 3 to 5 reflect the proportion of time a spontaneous manifest exotropia is present during 30 seconds of observation (\<50% score 3; \>50% score 4; 100% score 5). If no spontaneous manifest exotropia is observed, scores 0 to 2 reflect the longest time to regain fusion after three, 10-second dissociations (\>5 seconds score 2; 1-5 seconds score 1; \<1 second score 0).
Time frame: 18 months
| Arm | Measure | Group | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|---|
| Overminus Treatment | Change in Distance Control | >1 Point | 86 Participants |
| Overminus Treatment | Change in Distance Control | >2 Points | 48 Participants |
| Non-overminus Treatment | Change in Distance Control | >1 Point | 68 Participants |
| Non-overminus Treatment | Change in Distance Control | >2 Points | 30 Participants |
95% CI: [-7, 15]
95% CI: [-2, 17]
Secondary
Change in Near Control (12 Months)
For each timepoint, the change in near control since baseline will be reported. The Office Control Score provides a rating of exodeviation control on a 0 to 5 scale, in subjects with intermittent exotropia. Scores 3 to 5 reflect the proportion of time a spontaneous manifest exotropia is present during 30 seconds of observation (\<50% score 3; \>50% score 4; 100% score 5). If no spontaneous manifest exotropia is observed, scores 0 to 2 reflect the longest time to regain fusion after three, 10-second dissociations (\>5 seconds score 2; 1-5 seconds score 1; \<1 second score 0).
Time frame: 12 months
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| Overminus Treatment | Change in Near Control (12 Months) | 0.7 points | Standard Deviation 1.3 |
| Non-overminus Treatment | Change in Near Control (12 Months) | 0.1 points | Standard Deviation 1.4 |
Secondary
Change in Near Control (18 Months)
For each timepoint, the change in near control since baseline will be reported. The Office Control Score provides a rating of exodeviation control on a 0 to 5 scale, in subjects with intermittent exotropia. Scores 3 to 5 reflect the proportion of time a spontaneous manifest exotropia is present during 30 seconds of observation (\<50% score 3; \>50% score 4; 100% score 5). If no spontaneous manifest exotropia is observed, scores 0 to 2 reflect the longest time to regain fusion after three, 10-second dissociations (\>5 seconds score 2; 1-5 seconds score 1; \<1 second score 0).
Time frame: 18 months
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| Overminus Treatment | Change in Near Control (18 Months) | 0.4 points | Standard Deviation 1.4 |
| Non-overminus Treatment | Change in Near Control (18 Months) | 0.1 points | Standard Deviation 1.5 |
Secondary
Compliance With Spectacle Wear (12 Months)
Compliance with spectacle wear will be assessed at the 12-month and 18-month outcome exam. Parents will give an estimate of the proportion of the time their children wore their spectacles. Proportion of time worn will be described as excellent (76% to 100%), good (51% to 75%), fair (26% to 50%), or poor (≤ 25%). The distribution of compliance will be assessed for each treatment group at the outcome exam.
Time frame: 12 months
| Arm | Measure | Group | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|---|
| Overminus Treatment | Compliance With Spectacle Wear (12 Months) | Excellent (76-100%) | 143 Participants |
| Overminus Treatment | Compliance With Spectacle Wear (12 Months) | Good (51-75%) | 26 Participants |
| Overminus Treatment | Compliance With Spectacle Wear (12 Months) | Fair (26-50%) | 10 Participants |
| Overminus Treatment | Compliance With Spectacle Wear (12 Months) | Poor (1-25%) | 6 Participants |
| Overminus Treatment | Compliance With Spectacle Wear (12 Months) | Prescribed not wearing (0%) | 3 Participants |
| Overminus Treatment | Compliance With Spectacle Wear (12 Months) | Discontinued | 1 Participants |
| Non-overminus Treatment | Compliance With Spectacle Wear (12 Months) | Prescribed not wearing (0%) | 2 Participants |
| Non-overminus Treatment | Compliance With Spectacle Wear (12 Months) | Excellent (76-100%) | 128 Participants |
| Non-overminus Treatment | Compliance With Spectacle Wear (12 Months) | Poor (1-25%) | 2 Participants |
| Non-overminus Treatment | Compliance With Spectacle Wear (12 Months) | Good (51-75%) | 28 Participants |
| Non-overminus Treatment | Compliance With Spectacle Wear (12 Months) | Discontinued | 1 Participants |
| Non-overminus Treatment | Compliance With Spectacle Wear (12 Months) | Fair (26-50%) | 8 Participants |
Secondary
Compliance With Spectacle Wear (18 Months)
Compliance with spectacle wear will be assessed at the 12-month and 18-month outcome exam. Parents will give an estimate of the proportion of the time their children wore their spectacles. Proportion of time worn will be described as excellent (76% to 100%), good (51% to 75%), fair (26% to 50%), or poor (≤ 25%). The distribution of compliance will be assessed for each treatment group at the outcome exam.
Time frame: 18 months
| Arm | Measure | Group | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|---|
| Overminus Treatment | Compliance With Spectacle Wear (18 Months) | Excellent (76-100%) | 128 Participants |
| Overminus Treatment | Compliance With Spectacle Wear (18 Months) | Good (51-75%) | 23 Participants |
| Overminus Treatment | Compliance With Spectacle Wear (18 Months) | Fair (26-50%) | 8 Participants |
| Overminus Treatment | Compliance With Spectacle Wear (18 Months) | Poor (1-25%) | 9 Participants |
| Overminus Treatment | Compliance With Spectacle Wear (18 Months) | Prescribed not wearing (0%) | 5 Participants |
| Overminus Treatment | Compliance With Spectacle Wear (18 Months) | Discontinued | 3 Participants |
| Non-overminus Treatment | Compliance With Spectacle Wear (18 Months) | Prescribed not wearing (0%) | 1 Participants |
| Non-overminus Treatment | Compliance With Spectacle Wear (18 Months) | Excellent (76-100%) | 120 Participants |
| Non-overminus Treatment | Compliance With Spectacle Wear (18 Months) | Poor (1-25%) | 5 Participants |
| Non-overminus Treatment | Compliance With Spectacle Wear (18 Months) | Good (51-75%) | 14 Participants |
| Non-overminus Treatment | Compliance With Spectacle Wear (18 Months) | Discontinued | 2 Participants |
| Non-overminus Treatment | Compliance With Spectacle Wear (18 Months) | Fair (26-50%) | 13 Participants |
Secondary
Deterioration as Assessed by Motor Alignment and Stereoacuity at Near (12 Months)
The cumulative proportion of subjects who meet deterioration criteria by the time point will be estimated for each treatment group. Participants who meet either of the following at any visit by a specific timepoint (e.g., 12 months, 18 months) will be considered to have met deterioration criteria by that timepoint. * Motor deterioration: Control of the exodeviation measures 5 (constant exotropia) on all three assessments at distance and near. The exodeviation does not need to be constant throughout the entire exam provided that it is constant during all three assessments of control. * Stereoacuity deterioration: Drop in near stereoacuity of at least 2 octaves from enrollment stereoacuity, or to nil, confirmed by a retest by a Masked Examiner on a subsequent day. Note: participants with nil stereoacuity at enrollment will not be able to deteriorate with respect to a drop in near stereoacuity.
Time frame: 12 months
| Arm | Measure | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|
| Overminus Treatment | Deterioration as Assessed by Motor Alignment and Stereoacuity at Near (12 Months) | 5 Participants |
| Non-overminus Treatment | Deterioration as Assessed by Motor Alignment and Stereoacuity at Near (12 Months) | 7 Participants |
Secondary
Deterioration as Assessed by Motor Alignment and Stereoacuity at Near (18 Months)
The cumulative proportion of subjects who meet deterioration criteria by the time point will be estimated for each treatment group. Participants who meet either of the following at any visit by a specific timepoint (e.g., 12 months, 18 months) will be considered to have met deterioration criteria by that timepoint. * Motor deterioration: Control of the exodeviation measures 5 (constant exotropia) on all three assessments at distance and near. The exodeviation does not need to be constant throughout the entire exam provided that it is constant during all three assessments of control. * Stereoacuity deterioration: Drop in near stereoacuity of at least 2 octaves from enrollment stereoacuity, or to nil, confirmed by a retest by a Masked Examiner on a subsequent day. Note: participants with nil stereoacuity at enrollment will not be able to deteriorate with respect to a drop in near stereoacuity.
Time frame: 18 months
| Arm | Measure | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|
| Overminus Treatment | Deterioration as Assessed by Motor Alignment and Stereoacuity at Near (18 Months) | 6 Participants |
| Non-overminus Treatment | Deterioration as Assessed by Motor Alignment and Stereoacuity at Near (18 Months) | 16 Participants |
Secondary
Near Control (12 Months)
Mean control of the near exodeviation (average of 3 measurements over the exam). The Office Control Score provides a rating of exodeviation control on a 0 to 5 scale, in subjects with intermittent exotropia. Scores 3 to 5 reflect the proportion of time a spontaneous manifest exotropia is present during 30 seconds of observation (\<50% score 3; \>50% score 4; 100% score 5). If no spontaneous manifest exotropia is observed, scores 0 to 2 reflect the longest time to regain fusion after three, 10-second dissociations (\>5 seconds score 2; 1-5 seconds score 1; \<1 second score 0).
Time frame: 12 months
| Arm | Measure | Group | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|---|
| Overminus Treatment | Near Control (12 Months) | 1 to <2 points | 59 Participants |
| Overminus Treatment | Near Control (12 Months) | 3 to <4 points | 9 Participants |
| Overminus Treatment | Near Control (12 Months) | 2 to <3 points | 21 Participants |
| Overminus Treatment | Near Control (12 Months) | 4 to 5 points | 4 Participants |
| Overminus Treatment | Near Control (12 Months) | 0 to <1 points | 96 Participants |
| Non-overminus Treatment | Near Control (12 Months) | 4 to 5 points | 20 Participants |
| Non-overminus Treatment | Near Control (12 Months) | 0 to <1 points | 64 Participants |
| Non-overminus Treatment | Near Control (12 Months) | 1 to <2 points | 55 Participants |
| Non-overminus Treatment | Near Control (12 Months) | 2 to <3 points | 13 Participants |
| Non-overminus Treatment | Near Control (12 Months) | 3 to <4 points | 17 Participants |
Secondary
Near Control (18 Months)
Mean control of the near exodeviation (average of 3 measurements over the exam). The Office Control Score provides a rating of exodeviation control on a 0 to 5 scale, in subjects with intermittent exotropia. Scores 3 to 5 reflect the proportion of time a spontaneous manifest exotropia is present during 30 seconds of observation (\<50% score 3; \>50% score 4; 100% score 5). If no spontaneous manifest exotropia is observed, scores 0 to 2 reflect the longest time to regain fusion after three, 10-second dissociations (\>5 seconds score 2; 1-5 seconds score 1; \<1 second score 0).
Time frame: 18 months
| Arm | Measure | Group | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|---|
| Overminus Treatment | Near Control (18 Months) | 1 to <2 points | 60 Participants |
| Overminus Treatment | Near Control (18 Months) | 3 to <4 points | 15 Participants |
| Overminus Treatment | Near Control (18 Months) | 2 to <3 points | 16 Participants |
| Overminus Treatment | Near Control (18 Months) | 4 to 5 points | 13 Participants |
| Overminus Treatment | Near Control (18 Months) | 0 to <1 points | 72 Participants |
| Non-overminus Treatment | Near Control (18 Months) | 4 to 5 points | 16 Participants |
| Non-overminus Treatment | Near Control (18 Months) | 0 to <1 points | 59 Participants |
| Non-overminus Treatment | Near Control (18 Months) | 1 to <2 points | 46 Participants |
| Non-overminus Treatment | Near Control (18 Months) | 2 to <3 points | 18 Participants |
| Non-overminus Treatment | Near Control (18 Months) | 3 to <4 points | 16 Participants |
Secondary
No Spontaneous Tropia
The proportion of subjects with no spontaneous tropia at 12 months and at 18 months will be compared between treatment groups.
Time frame: At 18 months
| Arm | Measure | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|
| Overminus Treatment | No Spontaneous Tropia | 85 Participants |
| Non-overminus Treatment | No Spontaneous Tropia | 60 Participants |
Secondary
Number of Participants With No Spontaneous Tropia
The number of subjects with no spontaneous tropia at 12 months and at 18 months will be compared between treatment groups.
Time frame: 12 months
| Arm | Measure | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|
| Overminus Treatment | Number of Participants With No Spontaneous Tropia | 115 Participants |
| Non-overminus Treatment | Number of Participants With No Spontaneous Tropia | 62 Participants |
Secondary
Parent Symptom Survey [12 Months]
A brief survey of symptoms that may be associated with overminus such as headaches, eye strain, and problems with spectacle wear will be administered to the parents of the subjects. Parents are asked to respond to the survey questions based on their observations of their child in the past 2 weeks. Response options are based on frequency of observations; never, rarely, sometimes, often, always, and not applicable.
Time frame: At 12 months
Population: When number analyzed differs from full population size, it indicates that those children were not wearing spectacles, and therefore could not answer the spectacle related questions.
| Arm | Measure | Group | Category | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|---|---|
| Overminus Treatment | Parent Symptom Survey [12 Months] | Did your child have headaches? | Sometimes | 46 Participants |
| Overminus Treatment | Parent Symptom Survey [12 Months] | Did your child have headaches? | Often | 7 Participants |
| Overminus Treatment | Parent Symptom Survey [12 Months] | Did your child complain about hurt ears/nose? | Almost never | 43 Participants |
| Overminus Treatment | Parent Symptom Survey [12 Months] | Did your child complain about hurt ears/nose? | Sometimes | 18 Participants |
| Overminus Treatment | Parent Symptom Survey [12 Months] | Did your child have headaches? | Missing | 1 Participants |
| Overminus Treatment | Parent Symptom Survey [12 Months] | Did your child have headaches? | Never | 74 Participants |
| Overminus Treatment | Parent Symptom Survey [12 Months] | Did your child have headaches? | Almost never | 58 Participants |
| Overminus Treatment | Parent Symptom Survey [12 Months] | Did your child have headaches? | Almost Always | 3 Participants |
| Overminus Treatment | Parent Symptom Survey [12 Months] | Did your child have eyestrain? | Missing | 1 Participants |
| Overminus Treatment | Parent Symptom Survey [12 Months] | Did your child have eyestrain? | Never | 75 Participants |
| Overminus Treatment | Parent Symptom Survey [12 Months] | Did your child have eyestrain? | Almost never | 43 Participants |
| Overminus Treatment | Parent Symptom Survey [12 Months] | Did your child have eyestrain? | Sometimes | 60 Participants |
| Overminus Treatment | Parent Symptom Survey [12 Months] | Did your child have eyestrain? | Often | 9 Participants |
| Overminus Treatment | Parent Symptom Survey [12 Months] | Did your child have eyestrain? | Almost Always | 1 Participants |
| Overminus Treatment | Parent Symptom Survey [12 Months] | Did your child avoid reading? | Missing | 1 Participants |
| Overminus Treatment | Parent Symptom Survey [12 Months] | Did your child avoid reading? | Never | 112 Participants |
| Overminus Treatment | Parent Symptom Survey [12 Months] | Did your child avoid reading? | Almost never | 46 Participants |
| Overminus Treatment | Parent Symptom Survey [12 Months] | Did your child avoid reading? | Sometimes | 21 Participants |
| Overminus Treatment | Parent Symptom Survey [12 Months] | Did your child avoid reading? | Often | 7 Participants |
| Overminus Treatment | Parent Symptom Survey [12 Months] | Did your child avoid reading? | Almost Always | 2 Participants |
| Overminus Treatment | Parent Symptom Survey [12 Months] | Did your child have blurry vision? | Missing | 1 Participants |
| Overminus Treatment | Parent Symptom Survey [12 Months] | Did your child have blurry vision? | Never | 106 Participants |
| Overminus Treatment | Parent Symptom Survey [12 Months] | Did your child have blurry vision? | Almost never | 41 Participants |
| Overminus Treatment | Parent Symptom Survey [12 Months] | Did your child have blurry vision? | Sometimes | 34 Participants |
| Overminus Treatment | Parent Symptom Survey [12 Months] | Did your child have blurry vision? | Often | 5 Participants |
| Overminus Treatment | Parent Symptom Survey [12 Months] | Did your child have blurry vision? | Almost Always | 2 Participants |
| Overminus Treatment | Parent Symptom Survey [12 Months] | Did your child look over their spectacles? | Missing | 1 Participants |
| Overminus Treatment | Parent Symptom Survey [12 Months] | Did your child look over their spectacles? | Never | 66 Participants |
| Overminus Treatment | Parent Symptom Survey [12 Months] | Did your child look over their spectacles? | Almost never | 37 Participants |
| Overminus Treatment | Parent Symptom Survey [12 Months] | Did your child look over their spectacles? | Sometimes | 45 Participants |
| Overminus Treatment | Parent Symptom Survey [12 Months] | Did your child look over their spectacles? | Often | 25 Participants |
| Overminus Treatment | Parent Symptom Survey [12 Months] | Did your child look over their spectacles? | Almost Always | 11 Participants |
| Overminus Treatment | Parent Symptom Survey [12 Months] | Did your child take their spectacles off? | Missing | 1 Participants |
| Overminus Treatment | Parent Symptom Survey [12 Months] | Did your child take their spectacles off? | Never | 38 Participants |
| Overminus Treatment | Parent Symptom Survey [12 Months] | Did your child take their spectacles off? | Almost never | 45 Participants |
| Overminus Treatment | Parent Symptom Survey [12 Months] | Did your child take their spectacles off? | Sometimes | 63 Participants |
| Overminus Treatment | Parent Symptom Survey [12 Months] | Did your child take their spectacles off? | Often | 28 Participants |
| Overminus Treatment | Parent Symptom Survey [12 Months] | Did your child take their spectacles off? | Almost Always | 10 Participants |
| Overminus Treatment | Parent Symptom Survey [12 Months] | Did your child complain about hurt ears/nose? | Missing | 1 Participants |
| Overminus Treatment | Parent Symptom Survey [12 Months] | Did your child complain about hurt ears/nose? | Never | 112 Participants |
| Overminus Treatment | Parent Symptom Survey [12 Months] | Did your child complain about hurt ears/nose? | Often | 10 Participants |
| Overminus Treatment | Parent Symptom Survey [12 Months] | Did your child complain about hurt ears/nose? | Almost Always | 2 Participants |
| Non-overminus Treatment | Parent Symptom Survey [12 Months] | Did your child have blurry vision? | Never | 105 Participants |
| Non-overminus Treatment | Parent Symptom Survey [12 Months] | Did your child have headaches? | Sometimes | 32 Participants |
| Non-overminus Treatment | Parent Symptom Survey [12 Months] | Did your child take their spectacles off? | Missing | 1 Participants |
| Non-overminus Treatment | Parent Symptom Survey [12 Months] | Did your child have blurry vision? | Almost never | 36 Participants |
| Non-overminus Treatment | Parent Symptom Survey [12 Months] | Did your child complain about hurt ears/nose? | Almost never | 47 Participants |
| Non-overminus Treatment | Parent Symptom Survey [12 Months] | Did your child complain about hurt ears/nose? | Almost Always | 0 Participants |
| Non-overminus Treatment | Parent Symptom Survey [12 Months] | Did your child have blurry vision? | Sometimes | 26 Participants |
| Non-overminus Treatment | Parent Symptom Survey [12 Months] | Did your child have headaches? | Missing | 1 Participants |
| Non-overminus Treatment | Parent Symptom Survey [12 Months] | Did your child take their spectacles off? | Never | 32 Participants |
| Non-overminus Treatment | Parent Symptom Survey [12 Months] | Did your child have headaches? | Never | 71 Participants |
| Non-overminus Treatment | Parent Symptom Survey [12 Months] | Did your child have blurry vision? | Often | 1 Participants |
| Non-overminus Treatment | Parent Symptom Survey [12 Months] | Did your child have headaches? | Almost never | 64 Participants |
| Non-overminus Treatment | Parent Symptom Survey [12 Months] | Did your child have headaches? | Often | 1 Participants |
| Non-overminus Treatment | Parent Symptom Survey [12 Months] | Did your child complain about hurt ears/nose? | Missing | 1 Participants |
| Non-overminus Treatment | Parent Symptom Survey [12 Months] | Did your child have headaches? | Almost Always | 0 Participants |
| Non-overminus Treatment | Parent Symptom Survey [12 Months] | Did your child have blurry vision? | Almost Always | 0 Participants |
| Non-overminus Treatment | Parent Symptom Survey [12 Months] | Did your child have eyestrain? | Missing | 1 Participants |
| Non-overminus Treatment | Parent Symptom Survey [12 Months] | Did your child take their spectacles off? | Almost never | 51 Participants |
| Non-overminus Treatment | Parent Symptom Survey [12 Months] | Did your child have eyestrain? | Never | 56 Participants |
| Non-overminus Treatment | Parent Symptom Survey [12 Months] | Did your child look over their spectacles? | Missing | 1 Participants |
| Non-overminus Treatment | Parent Symptom Survey [12 Months] | Did your child have eyestrain? | Almost never | 56 Participants |
| Non-overminus Treatment | Parent Symptom Survey [12 Months] | Did your child complain about hurt ears/nose? | Often | 2 Participants |
| Non-overminus Treatment | Parent Symptom Survey [12 Months] | Did your child have eyestrain? | Sometimes | 50 Participants |
| Non-overminus Treatment | Parent Symptom Survey [12 Months] | Did your child look over their spectacles? | Never | 53 Participants |
| Non-overminus Treatment | Parent Symptom Survey [12 Months] | Did your child have eyestrain? | Often | 6 Participants |
| Non-overminus Treatment | Parent Symptom Survey [12 Months] | Did your child take their spectacles off? | Sometimes | 66 Participants |
| Non-overminus Treatment | Parent Symptom Survey [12 Months] | Did your child have eyestrain? | Almost Always | 0 Participants |
| Non-overminus Treatment | Parent Symptom Survey [12 Months] | Did your child look over their spectacles? | Almost never | 40 Participants |
| Non-overminus Treatment | Parent Symptom Survey [12 Months] | Did your child avoid reading? | Missing | 1 Participants |
| Non-overminus Treatment | Parent Symptom Survey [12 Months] | Did your child complain about hurt ears/nose? | Never | 96 Participants |
| Non-overminus Treatment | Parent Symptom Survey [12 Months] | Did your child avoid reading? | Never | 100 Participants |
| Non-overminus Treatment | Parent Symptom Survey [12 Months] | Did your child look over their spectacles? | Sometimes | 52 Participants |
| Non-overminus Treatment | Parent Symptom Survey [12 Months] | Did your child avoid reading? | Almost never | 43 Participants |
| Non-overminus Treatment | Parent Symptom Survey [12 Months] | Did your child take their spectacles off? | Often | 16 Participants |
| Non-overminus Treatment | Parent Symptom Survey [12 Months] | Did your child avoid reading? | Sometimes | 18 Participants |
| Non-overminus Treatment | Parent Symptom Survey [12 Months] | Did your child look over their spectacles? | Often | 17 Participants |
| Non-overminus Treatment | Parent Symptom Survey [12 Months] | Did your child avoid reading? | Often | 5 Participants |
| Non-overminus Treatment | Parent Symptom Survey [12 Months] | Did your child complain about hurt ears/nose? | Sometimes | 22 Participants |
| Non-overminus Treatment | Parent Symptom Survey [12 Months] | Did your child avoid reading? | Almost Always | 2 Participants |
| Non-overminus Treatment | Parent Symptom Survey [12 Months] | Did your child look over their spectacles? | Almost Always | 4 Participants |
| Non-overminus Treatment | Parent Symptom Survey [12 Months] | Did your child have blurry vision? | Missing | 1 Participants |
| Non-overminus Treatment | Parent Symptom Survey [12 Months] | Did your child take their spectacles off? | Almost Always | 2 Participants |
Secondary
Parent Symptom Survey [18 Months]
A brief survey of symptoms that may be associated with overminus such as headaches, eye strain, and problems with spectacle wear will be administered to the parents of the subjects. Parents are asked to respond to the survey questions based on their observations of their child in the past 2 weeks. Response options are based on frequency of observations; never, rarely, sometimes, often, always, and not applicable.
Time frame: At 18 months
Population: When number analyzed differs from full population size, it indicates that those children were not wearing spectacles, and therefore could not answer the spectacle related questions.
| Arm | Measure | Group | Category | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|---|---|
| Overminus Treatment | Parent Symptom Survey [18 Months] | Did your child have headaches? | Never | 76 Participants |
| Overminus Treatment | Parent Symptom Survey [18 Months] | Did your child have headaches? | Almost never | 49 Participants |
| Overminus Treatment | Parent Symptom Survey [18 Months] | Did your child have eyestrain? | Almost never | 52 Participants |
| Overminus Treatment | Parent Symptom Survey [18 Months] | Did your child have eyestrain? | Sometimes | 53 Participants |
| Overminus Treatment | Parent Symptom Survey [18 Months] | Did your child avoid reading? | Almost always | 2 Participants |
| Overminus Treatment | Parent Symptom Survey [18 Months] | Did your child have blurry vision? | Sometimes | 29 Participants |
| Overminus Treatment | Parent Symptom Survey [18 Months] | Did your child look over their spectacles? | Missing | 0 Participants |
| Overminus Treatment | Parent Symptom Survey [18 Months] | Did your child look over their spectacles? | Sometimes | 47 Participants |
| Overminus Treatment | Parent Symptom Survey [18 Months] | Did your child have headaches? | Missing | 0 Participants |
| Overminus Treatment | Parent Symptom Survey [18 Months] | Did your child have headaches? | Sometimes | 46 Participants |
| Overminus Treatment | Parent Symptom Survey [18 Months] | Did your child have headaches? | Often | 4 Participants |
| Overminus Treatment | Parent Symptom Survey [18 Months] | Did your child have headaches? | Almost always | 1 Participants |
| Overminus Treatment | Parent Symptom Survey [18 Months] | Did your child have eyestrain? | Missing | 0 Participants |
| Overminus Treatment | Parent Symptom Survey [18 Months] | Did your child have eyestrain? | Never | 66 Participants |
| Overminus Treatment | Parent Symptom Survey [18 Months] | Did your child have eyestrain? | Often | 3 Participants |
| Overminus Treatment | Parent Symptom Survey [18 Months] | Did your child have eyestrain? | Almost always | 2 Participants |
| Overminus Treatment | Parent Symptom Survey [18 Months] | Did your child avoid reading? | Missing | 0 Participants |
| Overminus Treatment | Parent Symptom Survey [18 Months] | Did your child avoid reading? | Never | 102 Participants |
| Overminus Treatment | Parent Symptom Survey [18 Months] | Did your child avoid reading? | Almost never | 44 Participants |
| Overminus Treatment | Parent Symptom Survey [18 Months] | Did your child avoid reading? | Sometimes | 24 Participants |
| Overminus Treatment | Parent Symptom Survey [18 Months] | Did your child avoid reading? | Often | 4 Participants |
| Overminus Treatment | Parent Symptom Survey [18 Months] | Did your child have blurry vision? | Missing | 0 Participants |
| Overminus Treatment | Parent Symptom Survey [18 Months] | Did your child have blurry vision? | Never | 99 Participants |
| Overminus Treatment | Parent Symptom Survey [18 Months] | Did your child have blurry vision? | Almost never | 46 Participants |
| Overminus Treatment | Parent Symptom Survey [18 Months] | Did your child have blurry vision? | Often | 1 Participants |
| Overminus Treatment | Parent Symptom Survey [18 Months] | Did your child have blurry vision? | Almost always | 1 Participants |
| Overminus Treatment | Parent Symptom Survey [18 Months] | Did your child look over their spectacles? | Never | 54 Participants |
| Overminus Treatment | Parent Symptom Survey [18 Months] | Did your child look over their spectacles? | Almost never | 46 Participants |
| Overminus Treatment | Parent Symptom Survey [18 Months] | Did your child look over their spectacles? | Often | 18 Participants |
| Overminus Treatment | Parent Symptom Survey [18 Months] | Did your child look over their spectacles? | Almost always | 8 Participants |
| Overminus Treatment | Parent Symptom Survey [18 Months] | Did your child take their spectacles off? | Missing | 0 Participants |
| Overminus Treatment | Parent Symptom Survey [18 Months] | Did your child take their spectacles off? | Never | 38 Participants |
| Overminus Treatment | Parent Symptom Survey [18 Months] | Did your child take their spectacles off? | Almost never | 36 Participants |
| Overminus Treatment | Parent Symptom Survey [18 Months] | Did your child take their spectacles off? | Sometimes | 69 Participants |
| Overminus Treatment | Parent Symptom Survey [18 Months] | Did your child take their spectacles off? | Often | 22 Participants |
| Overminus Treatment | Parent Symptom Survey [18 Months] | Did your child take their spectacles off? | Almost always | 7 Participants |
| Overminus Treatment | Parent Symptom Survey [18 Months] | Did your child complain about hurt ears/nose? | Missing | 0 Participants |
| Overminus Treatment | Parent Symptom Survey [18 Months] | Did your child complain about hurt ears/nose? | Never | 109 Participants |
| Overminus Treatment | Parent Symptom Survey [18 Months] | Did your child complain about hurt ears/nose? | Almost never | 41 Participants |
| Overminus Treatment | Parent Symptom Survey [18 Months] | Did your child complain about hurt ears/nose? | Sometimes | 18 Participants |
| Overminus Treatment | Parent Symptom Survey [18 Months] | Did your child complain about hurt ears/nose? | Often | 2 Participants |
| Overminus Treatment | Parent Symptom Survey [18 Months] | Did your child complain about hurt ears/nose? | Almost always | 4 Participants |
| Non-overminus Treatment | Parent Symptom Survey [18 Months] | Did your child take their spectacles off? | Never | 32 Participants |
| Non-overminus Treatment | Parent Symptom Survey [18 Months] | Did your child have blurry vision? | Missing | 1 Participants |
| Non-overminus Treatment | Parent Symptom Survey [18 Months] | Did your child have eyestrain? | Missing | 1 Participants |
| Non-overminus Treatment | Parent Symptom Survey [18 Months] | Did your child complain about hurt ears/nose? | Sometimes | 14 Participants |
| Non-overminus Treatment | Parent Symptom Survey [18 Months] | Did your child have blurry vision? | Never | 92 Participants |
| Non-overminus Treatment | Parent Symptom Survey [18 Months] | Did your child avoid reading? | Sometimes | 14 Participants |
| Non-overminus Treatment | Parent Symptom Survey [18 Months] | Did your child avoid reading? | Often | 4 Participants |
| Non-overminus Treatment | Parent Symptom Survey [18 Months] | Did your child take their spectacles off? | Almost never | 43 Participants |
| Non-overminus Treatment | Parent Symptom Survey [18 Months] | Did your child have blurry vision? | Almost never | 37 Participants |
| Non-overminus Treatment | Parent Symptom Survey [18 Months] | Did your child have blurry vision? | Sometimes | 23 Participants |
| Non-overminus Treatment | Parent Symptom Survey [18 Months] | Did your child have blurry vision? | Almost always | 1 Participants |
| Non-overminus Treatment | Parent Symptom Survey [18 Months] | Did your child complain about hurt ears/nose? | Never | 96 Participants |
| Non-overminus Treatment | Parent Symptom Survey [18 Months] | Did your child have blurry vision? | Often | 1 Participants |
| Non-overminus Treatment | Parent Symptom Survey [18 Months] | Did your child look over their spectacles? | Sometimes | 48 Participants |
| Non-overminus Treatment | Parent Symptom Survey [18 Months] | Did your child take their spectacles off? | Sometimes | 55 Participants |
| Non-overminus Treatment | Parent Symptom Survey [18 Months] | Did your child have headaches? | Missing | 1 Participants |
| Non-overminus Treatment | Parent Symptom Survey [18 Months] | Did your child have headaches? | Never | 63 Participants |
| Non-overminus Treatment | Parent Symptom Survey [18 Months] | Did your child have headaches? | Almost never | 55 Participants |
| Non-overminus Treatment | Parent Symptom Survey [18 Months] | Did your child look over their spectacles? | Missing | 1 Participants |
| Non-overminus Treatment | Parent Symptom Survey [18 Months] | Did your child have headaches? | Sometimes | 31 Participants |
| Non-overminus Treatment | Parent Symptom Survey [18 Months] | Did your child complain about hurt ears/nose? | Almost always | 1 Participants |
| Non-overminus Treatment | Parent Symptom Survey [18 Months] | Did your child have headaches? | Often | 3 Participants |
| Non-overminus Treatment | Parent Symptom Survey [18 Months] | Did your child look over their spectacles? | Never | 55 Participants |
| Non-overminus Treatment | Parent Symptom Survey [18 Months] | Did your child have headaches? | Almost always | 2 Participants |
| Non-overminus Treatment | Parent Symptom Survey [18 Months] | Did your child take their spectacles off? | Often | 13 Participants |
| Non-overminus Treatment | Parent Symptom Survey [18 Months] | Did your child look over their spectacles? | Almost never | 33 Participants |
| Non-overminus Treatment | Parent Symptom Survey [18 Months] | Did your child have eyestrain? | Never | 49 Participants |
| Non-overminus Treatment | Parent Symptom Survey [18 Months] | Did your child have eyestrain? | Almost never | 50 Participants |
| Non-overminus Treatment | Parent Symptom Survey [18 Months] | Did your child have eyestrain? | Sometimes | 49 Participants |
| Non-overminus Treatment | Parent Symptom Survey [18 Months] | Did your child complain about hurt ears/nose? | Almost never | 36 Participants |
| Non-overminus Treatment | Parent Symptom Survey [18 Months] | Did your child have eyestrain? | Often | 6 Participants |
| Non-overminus Treatment | Parent Symptom Survey [18 Months] | Did your child look over their spectacles? | Often | 9 Participants |
| Non-overminus Treatment | Parent Symptom Survey [18 Months] | Did your child have eyestrain? | Almost always | 0 Participants |
| Non-overminus Treatment | Parent Symptom Survey [18 Months] | Did your child take their spectacles off? | Almost always | 8 Participants |
| Non-overminus Treatment | Parent Symptom Survey [18 Months] | Did your child avoid reading? | Missing | 1 Participants |
| Non-overminus Treatment | Parent Symptom Survey [18 Months] | Did your child look over their spectacles? | Almost always | 5 Participants |
| Non-overminus Treatment | Parent Symptom Survey [18 Months] | Did your child avoid reading? | Never | 94 Participants |
| Non-overminus Treatment | Parent Symptom Survey [18 Months] | Did your child complain about hurt ears/nose? | Often | 4 Participants |
| Non-overminus Treatment | Parent Symptom Survey [18 Months] | Did your child avoid reading? | Almost never | 41 Participants |
| Non-overminus Treatment | Parent Symptom Survey [18 Months] | Did your child take their spectacles off? | Missing | 1 Participants |
| Non-overminus Treatment | Parent Symptom Survey [18 Months] | Did your child complain about hurt ears/nose? | Missing | 1 Participants |
| Non-overminus Treatment | Parent Symptom Survey [18 Months] | Did your child avoid reading? | Almost always | 1 Participants |
Secondary
Stereoacuity at 12 Months
A comparison of near stereoacuity will be assessed using the Randot Preschool stereotest at near (performed at 40 cm) between treatment groups.
Time frame: 12 months
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| Overminus Treatment | Stereoacuity at 12 Months | 2.0 arcseconds | Standard Deviation 0.4 |
| Non-overminus Treatment | Stereoacuity at 12 Months | 2.0 arcseconds | Standard Deviation 0.4 |
Secondary
Stereoacuity at 18 Months
A comparison of near stereoacuity will be assessed using the Randot Preschool stereotest at near (performed at 40 cm) between treatment groups.
Time frame: 18 months
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| Overminus Treatment | Stereoacuity at 18 Months | 1.9 arcseconds | Standard Deviation 0.4 |
| Non-overminus Treatment | Stereoacuity at 18 Months | 1.9 arcseconds | Standard Deviation 0.4 |