Hyperopia
Conditions
Keywords
Hyperopia, Glasses
Brief summary
The purpose of this study is to compare visual acuity outcomes and development of strabismus after a 3-year follow-up period in children age 12 to \<72 months with moderate hyperopia (spherical equivalent +3.00D to +6.00D) who are prescribed glasses either immediately or only after confirmation of pre-specified deterioration criteria.
Detailed description
Moderate and high hyperopia are associated with the development of strabismus and amblyopia. The primary aims of treatment for asymptomatic moderate and high hyperopia in preschool children are to facilitate the development of normal visual acuity and to prevent the development of esotropia and amblyopia. Treatment consists of optical correction, typically using glasses. For children with high hyperopia (\>+5.00D) and without strabismus or amblyopia, there is general consensus that a correction should be prescribed. Nevertheless, for children with moderate hyperopia (+3.00D to +5.00D) without strabismus or amblyopia, there is less consensus among pediatric eye care professionals. A survey by Lyons et al found that for a 2-year-old child with hyperopia greater than +3.00D, 65% of optometrists would prescribe glasses compared to 25% of ophthalmologists; for a 4-year old with hyperopia greater than +3.00D, 67% of optometrists would prescribe compared with 42% of ophthalmologists. The American Association for Pediatric Ophthalmology and Strabismus (AAPOS) recommends correcting +4.00D or more in 2 to 7 year olds and the American Academy of Ophthalmology recommends a threshold of +4.50D for correction in 2-to 3-year olds. Unlike ophthalmology, optometry does not provide specific recommendations based on age and level of refractive error. Such variation in practice highlights the lack of rigorously collected scientific evidence for the management of this condition. Across all levels of hyperopia, most ophthalmologists and optometrists usually prescribe less than the full cycloplegic refraction (71% in the Lyons survey) when no strabismus or amblyopia is present. The rationale for proactively correcting moderate hyperopia in an asymptomatic child is the prevention of esotropia, amblyopia, or asthenopia. The argument against correcting moderate hyperopia in an asymptomatic child is the expense and inconvenience of glasses that might be unnecessary and the potential disruption of emmetropization in infants and toddlers. At present, it remains uncertain whether correction of moderate hyperopia is beneficial in terms of visual acuity outcomes or strabismus development. There is some evidence that using partial correction of hyperopia allows emmetropization to take place. If refractive correction of moderate hyperopia does not reduce the incidence of amblyopia and/or esotropia compared to no refractive correction, then glasses can be avoided. However, if correcting moderate hyperopia does reduce the development of amblyopia and/or esotropia, then the benefits of preemptive refractive correction will have been identified.
Interventions
PROCEDUREGlasses
Glasses will be prescribed at enrollment with the sphere cut symmetrically by 1.00D and full cylinder correction.
Sponsors
Pediatric Eye Disease Investigator Group
National Eye Institute (NEI)
Jaeb Center for Health Research
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
SINGLE (Outcomes Assessor)
Eligibility
Sex/Gender
ALL
Age
12 Months to 71 Months
Healthy volunteers
No
Inclusion criteria
1. Age 12 to \< 72 months 2. Refractive error between +3.00D and +6.00D SE (by cycloplegic refraction) in either eye 3. Astigmatism \< 1.50D in both eyes 4. Spherical equivalent anisometropia ≤ +1.50D 5. For children 36 to \<72 months of age: 1. No evidence of subnormal visual acuity - Uncorrected monocular visual acuity in both eyes of 20/50 or better for age 36 to \<48 months,20/40 or better for age 48 to \<60 months, and 20/32 or better for ages 60 to \<72 months measured without cycloplegia using the ATS-HOTV© visual acuity testing protocol 2. Zero (0) or 1 logMAR line interocular difference (IOD) in uncorrected visual acuity measured without cycloplegia using the ATS-HOTV© visual acuity testing protocol 3. Age-normal stereoacuity on the Randot Preschool Stereotest (see Table 2 of protocol) 6. Gestational age \>32 weeks 7. Investigator is willing to prescribe glasses per protocol or observe the hyperopia untreated for 3 years unless specific criteria for deterioration outlined in section 3.3.3 are confirmed. 8. Parent understands the protocol and is willing to accept randomization to either glasses or no glasses initially, and is willing to wear glasses as prescribed or accept that glasses will not be prescribed by the investigator unless specific deterioration criteria outlined in section 3.3.3 are confirmed. 9. Parent has phone (or access to phone) and is willing to be contacted by Jaeb Center staff. 10. Relocation outside of area of an active PEDIG site for this study within the next 36 months is not anticipated.
Exclusion criteria
A patient is excluded for any of the following reasons: 1. Any measurable heterotropia at distance (3 meters) or at near (1/3 meter) by cover/uncover testing. Note that patients with heterophoria are eligible. 2. Previous documented strabismus (parental report must be confirmed by investigator) 3. Manifest or latent nystagmus evident clinically 4. Previous treatment of refractive error with glasses or contacts unless duration of glasses or contacts wear was one week or less and occurred more than 2 months prior to enrollment. 5. Previous intraocular, refractive, or extraocular muscle surgery 6. Previous amblyopia treatment 7. Previous vergence/accommodative therapy 8. Parental concerns over learning or development 9. Ocular co-morbidity that may reduce visual acuity 10. Symptoms of blur or asthenopia 11. Developmental delay diagnosed by pediatrician or Individualized Education Program (IEP) 12. Known neurological anomalies (e.g. cerebral palsy, Down syndrome) 13. Inability to perform visual acuity ATS-HOTV testing if ≥ 36 months of age
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Number of Participants With Confirmation of Failure Criteria | 36 months after randomization | At the 36-month visit, each subject's condition will be classified as either failure or not a failure. The primary analytic approach will be a treatment group comparison of the proportion meeting failure criteria at 36-months using the Fisher's exact test. The participant met failure criteria if ANY of the following criteria (except strabismus surgery prior to the 3-year outcome exam) were met during testing at the 3-year examination both with and without trial frames (without prism or bifocal), and the criteria was confirmed by a retest 1. Any measurable manifest strabismus in primary gaze at distance or at near not correctable with distance refractive correction alone 2. Strabismus surgery prior to the 36-month exam 3. Distance VA below age norms in either eye 4. ≥2 logMAR lines of IOD if VA is 20/25 or worse in the better-seeing eye 5. ≥3 logMAR lines of IOD if VA is 20/20 or better in the better-seeing eye 6. Stereoacuity measured at near below age normal values |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Subgroup Analysis - Gender | 36 months | Treatment effect in subgroups based on baseline factors will be assessed. Outcome failure status at 36 months will be tabulated by subgroup and reviewed for consistency. Total number of patients who experienced failure at 3 years are shown. |
| Subgroup Analysis - Family History of Amblyopia | 36 months | Treatment effect in subgroups based on baseline factors will be assessed. Outcome failure status at 36 months will be tabulated by subgroup and reviewed for consistency. Total number of patients who experienced failure at 3 years are shown. |
| Subgroup Analysis - Family History of Strabismus | 36 months | Treatment effect in subgroups based on baseline factors will be assessed. Outcome failure status at 36 months will be tabulated by subgroup and reviewed for consistency. Total number of patients who experienced failure at 3 years are shown. |
| Subgroup Analysis - SE Anisometropia | 36 months | Treatment effect in subgroups based on baseline factors will be assessed. Outcome failure status at 36 months will be tabulated by subgroup and reviewed for consistency. Total number of patients who experienced failure at 3 years are shown. |
| Subgroup Analysis - Mean Refractive Error at Enrollment (Diopters) | 36 months | Treatment effect in subgroups based on baseline factors will be assessed. Outcome failure status at 36 months will be tabulated by subgroup and reviewed for consistency. Total number of patients who experienced failure at 3 years are shown. |
| Deterioration Criteria Met (Prior to 3 Years) | Enrollment to <36 months | Estimate of Cumulative Deterioration Rate. Proportion of subjects who deteriorated during the course of the study were evaluated. Reasons for deterioration included stereoacuity, strabismus, treatment due to parental concern, and treatment that was prescribed against protocol. |
| Mean Change in Spherical Equivalent (SE) Refractive Error (Diopters) | Enrollment to 3 years | Refractive error is the measurement of the power of the lenses needed to focus light on the retina. This is measured in diopters (D). Spherical Equivalent is a pair of numbers, one for each eye, that gives an estimate of the refractive error in the eyes. Hyperopia is farsightedness, or a type of refractive error in which things are seen more clearly at a distance than at near. Myopia is nearsightedness, or refractive error in which things are seen more clearly at near. Mean change in SE refractive error is from baseline to 3 years, measured in diopters. Negative values indicate a shift in the myopic direction. |
| Subgroup Analysis - Race | 36 months after randomization | Treatment effect in subgroups based on baseline factors will be assessed. Outcome failure status at 36 months will be tabulated by subgroup and reviewed for consistency. Total number of patients who experienced failure at 3 years are shown. |
| Best Visual Acuity | 36 months after randomization | A treatment group comparison of the mean maximum visual acuity per subject at the masked 36-month visit (best visual acuity on any test with and without correction) will be performed using a t-test. Evaluated the best of the values reported with and without trial frames, during initial assessment and retest. Snellen visual acuity (VA) equivalents were converted to logarithm of minimum angle of resolution (logMAR) equivalents (in parentheses) as follows: 20/16 (-0.1), 20/20 (0), 20/25 (0.1), 20/32 (0.2), 20/40 (0.3), 20/50 (0.4) A logMAR value of less than 0 is associated with better than 20/20 vision, while a logMAR value greater than 0 is associated with worse than 20/20 vision. |
| Failure to Meet Age-Normal VA at Distance | 36 months | Proportion who failed to meet age-normal VA at distance at 3 years. Participants were classified as failing to meet age-normal visual acuity if, for either eye, distance visual acuity was below age-normal values both with and without trial frames, during initial assessment and re-test. |
| Proportion With Amblyopia (at Distance) | 36 months after randomization | A treatment group comparison of the proportion of subjects who developed amblyopia at distance during the course of the study will be performed using the Barnard's exact test. Participants were classified as having amblyopia if any of the following criteria were met: 1) the interocular difference was ≥2 logMAR lines of IOD if VA is 20/25 or worse in the better-seeing eye, or 2) the interocular differences was ≥3 logMAR lines of IOD if VA is 20/20 or better in the better-seeing eye. 3) VA less than age normal in each eye (presumed bilateral amblyopia) |
| Binocular Near Visual Acuity | 36 months after randomization | A treatment group comparison of the mean binocular near visual acuity (logarithm of minimum angle of resolution, or logMAR) at the 36-month outcome exam will be performed. Assessment completed in randomized correction. Snellen visual acuity (VA) equivalents were converted to logarithm of minimum angle of resolution (logMAR) equivalents (in parentheses) as follows: 20/16 (-0.1), 20/20 (0), 20/25 (0.1), 20/32 (0.2), 20/40 (0.3), 20/50 (0.4) A logMAR value of less than 0 is associated with better than 20/20 vision, while a logMAR value greater than 0 is associated with worse than 20/20 vision. |
| Number of Participants With Strabismus at 3 Years | 36 months after randomization | The number of participants who developed measurable heterotropia was estimated for each treatment group and the proportions were compared using Barnard's exact test. |
| Mean Stereoacuity | 36 months | Mean stereoacuity at 3 years was measured in log seconds of arc (log arcsec) (see explanation below). Evaluated the best of the values reported with and without trial frames, during initial assessment and retest. Stereoacuity scores (seconds of arc) were calculated based on the Randot Preschool stereoacuity test (scores: 800, 400, 200, 100, 60 and 40). Seconds of arc refers to the visual angle that is being measured in order to determine depth perception. Lower scores indicate better stereoacuity. A logarithm base 10 transformation was used to convert stereoacuity scores to the log scale to calculate descriptive statistics (reported as seconds of arc, or arcsec). Seconds of arc were converted to logarithm of seconds of arc, or log arcsec (in parentheses) as follows: 40 (1.60), 60(1.78), 100 (2.00), 200 (2.30), 400 (2.60), 800 (2.90), Nil (3.20) |
| Failure to Meet Age-Normal Stereoacuity at 3 Years | 36 months | Proportion who failed to meet age-normal stereoacuity. Participants were classified as failing to meet age-normal stereoacuity if near stereoacuity was below age-normal values both with and without trial frames, during initial assessment and re-test. |
| Percentage of Participants With Hyperopia Reduction | Enrollment to 3 years | Percentage of Participants (%) in which hyperopia reduced by 1.00D (diopters) or more over 3 years |
Countries
United States
Participant flow
Participants by arm
| Arm | Count |
|---|---|
| Glasses- Older Cohort Glasses are prescribed at enrollment and worn per protocol throughout the duration of the study.
Glasses: For patients in the glasses group, glasses will be prescribed at enrollment with the sphere cut symmetrically by 1.00D and full cylinder correction. If a subject in the observation group has confirmed deterioration, glasses will be prescribed with amount of correction at investigator discretion. | 61 |
| Observation- Older Cohort Glasses will not be prescribed unless the patient has confirmation of one or more deterioration criteria as described in the protocol.
Glasses: For patients in the glasses group, glasses will be prescribed at enrollment with the sphere cut symmetrically by 1.00D and full cylinder correction. If a subject in the observation group has confirmed deterioration, glasses will be prescribed with amount of correction at investigator discretion. | 58 |
| Glasses- Younger Cohort Glasses are prescribed at enrollment and worn per protocol throughout the duration of the study.
Glasses: For patients in the glasses group, glasses will be prescribed at enrollment with the sphere cut symmetrically by 1.00D and full cylinder correction. If a subject in the observation group has confirmed deterioration, glasses will be prescribed with amount of correction at investigator discretion. | 65 |
| Observation- Younger Cohort Glasses will not be prescribed unless the patient has confirmation of one or more deterioration criteria as described in the protocol.
Glasses: For patients in the glasses group, glasses will be prescribed at enrollment with the sphere cut symmetrically by 1.00D and full cylinder correction. If a subject in the observation group has confirmed deterioration, glasses will be prescribed with amount of correction at investigator discretion. | 65 |
| Total | 249 |
Withdrawals & dropouts
| Period | Reason | FG000 | FG001 | FG002 | FG003 |
|---|---|---|---|---|---|
| Overall Study | Lost to Follow-up | 20 | 15 | 12 | 12 |
Baseline characteristics
| Characteristic | Glasses- Older Cohort | Observation- Older Cohort | Glasses- Younger Cohort | Observation- Younger Cohort | Total |
|---|---|---|---|---|---|
| Age, Categorical <=18 years | 61 Participants | 58 Participants | 65 Participants | 65 Participants | 249 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, Customized 1 Year | 0 Participants | 0 Participants | 42 Participants | 42 Participants | 84 Participants |
| Age, Customized 2 Years | 0 Participants | 0 Participants | 23 Participants | 23 Participants | 46 Participants |
| Age, Customized 3 Years | 19 Participants | 20 Participants | 0 Participants | 0 Participants | 39 Participants |
| Age, Customized 4 Years | 31 Participants | 30 Participants | 0 Participants | 0 Participants | 61 Participants |
| Age, Customized 5 Years | 11 Participants | 8 Participants | 0 Participants | 0 Participants | 19 Participants |
| Anisometropia 0.00 to <+0.50 | 42 Participants | 39 Participants | 47 Participants | 46 Participants | 174 Participants |
| Anisometropia +0.50D to <+1.00D | 16 Participants | 14 Participants | 13 Participants | 12 Participants | 55 Participants |
| Anisometropia +1.00D to +1.50D | 3 Participants | 5 Participants | 5 Participants | 7 Participants | 20 Participants |
| Anisometropia | 0.33 diopters (D) STANDARD_DEVIATION 0.36 | 0.34 diopters (D) STANDARD_DEVIATION 0.34 | 0.28 diopters (D) STANDARD_DEVIATION 0.38 | 0.30 diopters (D) STANDARD_DEVIATION 0.39 | 0.31 diopters (D) STANDARD_DEVIATION 0.37 |
| Astigmatism: Less astigmatic eye 0.00D to <+0.50D | 40 Participants | 41 Participants | 41 Participants | 39 Participants | 161 Participants |
| Astigmatism: Less astigmatic eye +0.50D to <+1.00D | 14 Participants | 12 Participants | 17 Participants | 13 Participants | 56 Participants |
| Astigmatism: Less astigmatic eye +1.00D to +1.50D | 7 Participants | 5 Participants | 7 Participants | 13 Participants | 32 Participants |
| Astigmatism: Less astigmatic eye | 0.32 diopters (D) STANDARD_DEVIATION 0.42 | 0.25 diopters (D) STANDARD_DEVIATION 0.36 | 0.27 diopters (D) STANDARD_DEVIATION 0.38 | 0.37 diopters (D) STANDARD_DEVIATION 0.47 | 0.31 diopters (D) STANDARD_DEVIATION 0.41 |
| Astigmatism: More astigmatic eye 0.00D to <+0.50D | 29 Participants | 29 Participants | 36 Participants | 29 Participants | 123 Participants |
| Astigmatism: More astigmatic eye +0.50D to <+1.00D | 23 Participants | 18 Participants | 18 Participants | 19 Participants | 78 Participants |
| Astigmatism: More astigmatic eye +1.00D to +1.50D | 9 Participants | 11 Participants | 11 Participants | 17 Participants | 48 Participants |
| Astigmatism: More astigmatic eye | 0.45 diopters (D) STANDARD_DEVIATION 0.45 | 0.44 diopters (D) STANDARD_DEVIATION 0.44 | 0.40 diopters (D) STANDARD_DEVIATION 0.48 | 0.49 diopters (D) STANDARD_DEVIATION 0.48 | 0.45 diopters (D) STANDARD_DEVIATION 0.46 |
| Diagnosis Of ADHD | 0 Participants | 0 Participants | 0 Participants | 0 Participants | 0 Participants |
| Distance Visual Acuity: Better-seeing Eye 20/16 | 5 Participants | 3 Participants | — | — | 8 Participants |
| Distance Visual Acuity: Better-seeing Eye 20/20 | 16 Participants | 18 Participants | — | — | 34 Participants |
| Distance Visual Acuity: Better-seeing Eye 20/25 | 25 Participants | 18 Participants | — | — | 43 Participants |
| Distance Visual Acuity: Better-seeing Eye 20/32 | 9 Participants | 13 Participants | — | — | 22 Participants |
| Distance Visual Acuity: Better-seeing Eye 20/40 | 6 Participants | 6 Participants | — | — | 12 Participants |
| Distance Visual Acuity: Better-seeing Eye 20/50 | 0 Participants | 0 Participants | — | — | 0 Participants |
| Distance Visual Acuity: Better-seeing Eye | 0.09 logMAR STANDARD_DEVIATION 0.11 | 0.10 logMAR STANDARD_DEVIATION 0.11 | — | — | 0.10 logMAR STANDARD_DEVIATION 0.11 |
| Distance Visual Acuity: Worse-seeing Eye 20/16 | 2 Participants | 0 Participants | — | — | 2 Participants |
| Distance Visual Acuity: Worse-seeing Eye 20/20 | 7 Participants | 7 Participants | — | — | 14 Participants |
| Distance Visual Acuity: Worse-seeing Eye 20/25 | 26 Participants | 25 Participants | — | — | 51 Participants |
| Distance Visual Acuity: Worse-seeing Eye 20/32 | 15 Participants | 15 Participants | — | — | 30 Participants |
| Distance Visual Acuity: Worse-seeing Eye 20/40 | 8 Participants | 9 Participants | — | — | 17 Participants |
| Distance Visual Acuity: Worse-seeing Eye 20/50 | 3 Participants | 2 Participants | — | — | 5 Participants |
| Distance Visual Acuity: Worse-seeing Eye | 0.15 logMAR STANDARD_DEVIATION 0.11 | 0.16 logMAR STANDARD_DEVIATION 0.1 | — | — | 0.15 logMAR STANDARD_DEVIATION 0.11 |
| Family History of Amblyopia | 16 Participants | 17 Participants | 21 Participants | 20 Participants | 74 Participants |
| Family History of Strabismus | 11 Participants | 16 Participants | 26 Participants | 25 Participants | 78 Participants |
| Race/Ethnicity, Customized Asian | 2 Participants | 0 Participants | 1 Participants | 0 Participants | 3 Participants |
| Race/Ethnicity, Customized Black/African American | 12 Participants | 14 Participants | 2 Participants | 3 Participants | 31 Participants |
| Race/Ethnicity, Customized Hispanic | 13 Participants | 7 Participants | 7 Participants | 8 Participants | 35 Participants |
| Race/Ethnicity, Customized More than one race | 0 Participants | 1 Participants | 2 Participants | 2 Participants | 5 Participants |
| Race/Ethnicity, Customized Unknown/Not reported | 0 Participants | 1 Participants | 0 Participants | 0 Participants | 1 Participants |
| Race/Ethnicity, Customized White | 34 Participants | 35 Participants | 53 Participants | 52 Participants | 174 Participants |
| SE Refractive Error: Less hyperopic eye +1.00 to <+2.00 D | 0 Participants | 0 Participants | 0 Participants | 1 Participants | 1 Participants |
| SE Refractive Error: Less hyperopic eye +2.00 to <+3.00D | 10 Participants | 10 Participants | 4 Participants | 2 Participants | 26 Participants |
| SE Refractive Error: Less hyperopic eye +3.00 to <+4.00D | 34 Participants | 30 Participants | 26 Participants | 27 Participants | 117 Participants |
| SE Refractive Error: Less hyperopic eye +4.00 to <+5.00D | 12 Participants | 13 Participants | 22 Participants | 21 Participants | 68 Participants |
| SE Refractive Error: Less hyperopic eye +5.00 to <+6.00D | 5 Participants | 5 Participants | 13 Participants | 11 Participants | 34 Participants |
| SE Refractive Error: Less hyperopic eye +6.00 to <+7.00D | 0 Participants | 0 Participants | 0 Participants | 3 Participants | 3 Participants |
| SE Refractive Error: Less hyperopic eye | 3.60 diopters (D) STANDARD_DEVIATION 0.78 | 3.59 diopters (D) STANDARD_DEVIATION 0.81 | 4.04 diopters (D) STANDARD_DEVIATION 0.85 | 4.07 diopters (D) STANDARD_DEVIATION 0.9 | 3.84 diopters (D) STANDARD_DEVIATION 0.86 |
| SE Refractive Error: More hyperopic eye +1.00 to <+2.00 D | 0 Participants | 0 Participants | 0 Participants | 0 Participants | 0 Participants |
| SE Refractive Error: More hyperopic eye +2.00D to <+3.00D | 0 Participants | 0 Participants | 0 Participants | 0 Participants | 0 Participants |
| SE Refractive Error: More hyperopic eye +3.00D to <+4.00D | 37 Participants | 32 Participants | 25 Participants | 20 Participants | 114 Participants |
| SE Refractive Error: More hyperopic eye +4.00D to <+5.00D | 16 Participants | 19 Participants | 19 Participants | 27 Participants | 81 Participants |
| SE Refractive Error: More hyperopic eye +5.00D to +6.00D | 8 Participants | 7 Participants | 20 Participants | 13 Participants | 48 Participants |
| SE Refractive Error: More hyperopic eye +6.00 to +7.00 D | 0 Participants | 0 Participants | 1 Participants | 5 Participants | 6 Participants |
| SE Refractive Error: More hyperopic eye | 3.93 diopters (D) STANDARD_DEVIATION 0.71 | 3.94 diopters (D) STANDARD_DEVIATION 0.74 | 4.32 diopters (D) STANDARD_DEVIATION 0.85 | 4.37 diopters (D) STANDARD_DEVIATION 0.87 | 4.15 diopters (D) STANDARD_DEVIATION 0.82 |
| Sex: Female, Male Female | 38 Participants | 32 Participants | 33 Participants | 35 Participants | 138 Participants |
| Sex: Female, Male Male | 23 Participants | 26 Participants | 32 Participants | 30 Participants | 111 Participants |
| Stereoacuity at Near 100 | 13 Participants | 15 Participants | — | — | 28 Participants |
| Stereoacuity at Near 200 | 12 Participants | 16 Participants | — | — | 28 Participants |
| Stereoacuity at Near 40 | 9 Participants | 7 Participants | — | — | 16 Participants |
| Stereoacuity at Near 400 | 6 Participants | 6 Participants | — | — | 12 Participants |
| Stereoacuity at Near 60 | 21 Participants | 12 Participants | — | — | 33 Participants |
| Stereoacuity at Near Failed pretest | 0 Participants | 1 Participants | — | — | 1 Participants |
| Stereoacuity at Near Nil | 0 Participants | 1 Participants | — | — | 1 Participants |
| Stereoacuity at Near | 100 seconds of arc (arcsec) | 100 seconds of arc (arcsec) | — | — | 100 seconds of arc (arcsec) |
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 / 41 | 0 / 43 | 0 / 53 | 0 / 53 |
| other Total, other adverse events | 0 / 41 | 0 / 43 | 0 / 53 | 0 / 53 |
| serious Total, serious adverse events | 0 / 41 | 0 / 43 | 0 / 53 | 0 / 53 |
Outcome results
Primary
Number of Participants With Confirmation of Failure Criteria
At the 36-month visit, each subject's condition will be classified as either failure or not a failure. The primary analytic approach will be a treatment group comparison of the proportion meeting failure criteria at 36-months using the Fisher's exact test. The participant met failure criteria if ANY of the following criteria (except strabismus surgery prior to the 3-year outcome exam) were met during testing at the 3-year examination both with and without trial frames (without prism or bifocal), and the criteria was confirmed by a retest 1. Any measurable manifest strabismus in primary gaze at distance or at near not correctable with distance refractive correction alone 2. Strabismus surgery prior to the 36-month exam 3. Distance VA below age norms in either eye 4. ≥2 logMAR lines of IOD if VA is 20/25 or worse in the better-seeing eye 5. ≥3 logMAR lines of IOD if VA is 20/20 or better in the better-seeing eye 6. Stereoacuity measured at near below age normal values
Time frame: 36 months after randomization
Population: Overall number is the number of patients who completed the entire study.
| Arm | Measure | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|
| Glasses- Older Cohort | Number of Participants With Confirmation of Failure Criteria | 5 Participants |
| Observation- Older Cohort | Number of Participants With Confirmation of Failure Criteria | 4 Participants |
| Glasses- Younger Cohort | Number of Participants With Confirmation of Failure Criteria | 11 Participants |
| Observation- Younger Cohort | Number of Participants With Confirmation of Failure Criteria | 18 Participants |
p-value: 0.7295% CI: [-12, 18]Barnard's Exact Test
p-value: 0.1495% CI: [-31, 4]Barnard's Exact Test
Secondary
Best Visual Acuity
A treatment group comparison of the mean maximum visual acuity per subject at the masked 36-month visit (best visual acuity on any test with and without correction) will be performed using a t-test. Evaluated the best of the values reported with and without trial frames, during initial assessment and retest. Snellen visual acuity (VA) equivalents were converted to logarithm of minimum angle of resolution (logMAR) equivalents (in parentheses) as follows: 20/16 (-0.1), 20/20 (0), 20/25 (0.1), 20/32 (0.2), 20/40 (0.3), 20/50 (0.4) A logMAR value of less than 0 is associated with better than 20/20 vision, while a logMAR value greater than 0 is associated with worse than 20/20 vision.
Time frame: 36 months after randomization
| Arm | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| Glasses- Older Cohort | Best Visual Acuity | Better-seeing Eye | -0.06 logMAR | Standard Deviation 0.06 |
| Glasses- Older Cohort | Best Visual Acuity | Worse-seeing Eye | -0.03 logMAR | Standard Deviation 0.08 |
| Observation- Older Cohort | Best Visual Acuity | Worse-seeing Eye | -0.01 logMAR | Standard Deviation 0.1 |
| Observation- Older Cohort | Best Visual Acuity | Better-seeing Eye | -0.07 logMAR | Standard Deviation 0.05 |
| Glasses- Younger Cohort | Best Visual Acuity | Better-seeing Eye | 0.06 logMAR | Standard Deviation 0.12 |
| Glasses- Younger Cohort | Best Visual Acuity | Worse-seeing Eye | 0.16 logMAR | Standard Deviation 0.23 |
| Observation- Younger Cohort | Best Visual Acuity | Better-seeing Eye | 0.12 logMAR | Standard Deviation 0.13 |
| Observation- Younger Cohort | Best Visual Acuity | Worse-seeing Eye | 0.23 logMAR | Standard Deviation 0.26 |
Comparison: Test for Difference in Means in Better-Seeing Eye: Older Cohort~An analysis of covariance model, adjusting for age at the 3-year visit and visual acuity at baseline, was used to compare mean visual acuity between treatment groups. Results are considered statistically significant if p\<0.01.p-value: 0.2299% CI: [-0.02, 0.04]ANCOVA
Comparison: Test for Difference in Means in Worse-Seeing Eye: Older Cohort~An analysis of covariance model, adjusting for age at the 3-year visit and visual acuity at baseline, was used to compare mean visual acuity between treatment groups. Results are considered statistically significant if p\<0.01.p-value: 0.4199% CI: [-0.06, 0.03]ANCOVA
Comparison: Test for Difference in Means in Better-Seeing Eye: Younger Cohort~An analysis of covariance model, adjusting for age at the 3-year visit and visual acuity at baseline, was used to compare mean visual acuity between treatment groups. Results are considered statistically significant if p\<0.01.p-value: 0.0299% CI: [-0.12, 0.01]ANCOVA
Comparison: Test for Difference in Means in Worse-Seeing Eye: Younger Cohort~An analysis of covariance model, adjusting for age at the 3-year visit and visual acuity at baseline, was used to compare mean visual acuity between treatment groups. Results are considered statistically significant if p\<0.01.p-value: 0.1599% CI: [-0.19, 0.05]ANCOVA
Secondary
Binocular Near Visual Acuity
A treatment group comparison of the mean binocular near visual acuity (logarithm of minimum angle of resolution, or logMAR) at the 36-month outcome exam will be performed. Assessment completed in randomized correction. Snellen visual acuity (VA) equivalents were converted to logarithm of minimum angle of resolution (logMAR) equivalents (in parentheses) as follows: 20/16 (-0.1), 20/20 (0), 20/25 (0.1), 20/32 (0.2), 20/40 (0.3), 20/50 (0.4) A logMAR value of less than 0 is associated with better than 20/20 vision, while a logMAR value greater than 0 is associated with worse than 20/20 vision.
Time frame: 36 months after randomization
Population: Overall number is the total number of patients who completed the 3-year study.
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| Glasses- Older Cohort | Binocular Near Visual Acuity | 0.01 logMAR | Standard Deviation 0.04 |
| Observation- Older Cohort | Binocular Near Visual Acuity | 0.04 logMAR | Standard Deviation 0.14 |
| Glasses- Younger Cohort | Binocular Near Visual Acuity | 0.09 logMAR | Standard Deviation 0.11 |
| Observation- Younger Cohort | Binocular Near Visual Acuity | 0.12 logMAR | Standard Deviation 0.12 |
Comparison: An analysis of covariance model, adjusting for age at the 3-year visit and visual acuity at baseline, was used to compare mean visual acuity between treatment groups.p-value: 0.2199% CI: [-0.12, 0.05]ANCOVA
Comparison: An analysis of covariance model, adjusting for age at the 3-year visit and visual acuity at baseline, was used to compare mean visual acuity between treatment groups.p-value: 0.2599% CI: [-0.1, 0.04]ANCOVA
Secondary
Deterioration Criteria Met (Prior to 3 Years)
Estimate of Cumulative Deterioration Rate. Proportion of subjects who deteriorated during the course of the study were evaluated. Reasons for deterioration included stereoacuity, strabismus, treatment due to parental concern, and treatment that was prescribed against protocol.
Time frame: Enrollment to <36 months
| Arm | Measure | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|
| Glasses- Older Cohort | Deterioration Criteria Met (Prior to 3 Years) | 16 Participants |
| Observation- Older Cohort | Deterioration Criteria Met (Prior to 3 Years) | 14 Participants |
| Glasses- Younger Cohort | Deterioration Criteria Met (Prior to 3 Years) | 20 Participants |
| Observation- Younger Cohort | Deterioration Criteria Met (Prior to 3 Years) | 36 Participants |
Secondary
Failure to Meet Age-Normal Stereoacuity at 3 Years
Proportion who failed to meet age-normal stereoacuity. Participants were classified as failing to meet age-normal stereoacuity if near stereoacuity was below age-normal values both with and without trial frames, during initial assessment and re-test.
Time frame: 36 months
Population: Overall number is the total number of patients who completed the 3-year study.
| Arm | Measure | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|
| Glasses- Older Cohort | Failure to Meet Age-Normal Stereoacuity at 3 Years | 5 Participants |
| Observation- Older Cohort | Failure to Meet Age-Normal Stereoacuity at 3 Years | 3 Participants |
| Glasses- Younger Cohort | Failure to Meet Age-Normal Stereoacuity at 3 Years | 6 Participants |
| Observation- Younger Cohort | Failure to Meet Age-Normal Stereoacuity at 3 Years | 16 Participants |
Comparison: Barnard's exact test used to compare proportions between treatment groupsp-value: 0.5399% CI: [-14, 26]Barnard's Exact Test
Comparison: Barnard's exact test used to compare proportions between treatment groups.p-value: 0.0299% CI: [-40, 2]Barnard's Exact Test
Secondary
Failure to Meet Age-Normal VA at Distance
Proportion who failed to meet age-normal VA at distance at 3 years. Participants were classified as failing to meet age-normal visual acuity if, for either eye, distance visual acuity was below age-normal values both with and without trial frames, during initial assessment and re-test.
Time frame: 36 months
Population: Overall number is the total number of patients who completed the 3-year study.
| Arm | Measure | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|
| Glasses- Older Cohort | Failure to Meet Age-Normal VA at Distance | 0 Participants |
| Observation- Older Cohort | Failure to Meet Age-Normal VA at Distance | 1 Participants |
| Glasses- Younger Cohort | Failure to Meet Age-Normal VA at Distance | 3 Participants |
| Observation- Younger Cohort | Failure to Meet Age-Normal VA at Distance | 4 Participants |
Comparison: Barnard's exact test was used to compare proportions between treatment groups.p-value: 0.5199% CI: [-18, 13]Barnard's Exact Test
Comparison: Barnard's exact test was used to compare proportions between treatment groups.p-value: 0.7999% CI: [-18, 14]Barnard's Exact Test
Secondary
Mean Change in Spherical Equivalent (SE) Refractive Error (Diopters)
Refractive error is the measurement of the power of the lenses needed to focus light on the retina. This is measured in diopters (D). Spherical Equivalent is a pair of numbers, one for each eye, that gives an estimate of the refractive error in the eyes. Hyperopia is farsightedness, or a type of refractive error in which things are seen more clearly at a distance than at near. Myopia is nearsightedness, or refractive error in which things are seen more clearly at near. Mean change in SE refractive error is from baseline to 3 years, measured in diopters. Negative values indicate a shift in the myopic direction.
Time frame: Enrollment to 3 years
Population: Overall number is the total number of patients who completed the 3-year study.
| Arm | Measure | Group | Value (MEAN) |
|---|---|---|---|
| Glasses- Older Cohort | Mean Change in Spherical Equivalent (SE) Refractive Error (Diopters) | More Hyperopic Eye | -0.07 diopters |
| Glasses- Older Cohort | Mean Change in Spherical Equivalent (SE) Refractive Error (Diopters) | Less Hyperopic Eye | 0 diopters |
| Observation- Older Cohort | Mean Change in Spherical Equivalent (SE) Refractive Error (Diopters) | Less Hyperopic Eye | -0.58 diopters |
| Observation- Older Cohort | Mean Change in Spherical Equivalent (SE) Refractive Error (Diopters) | More Hyperopic Eye | -0.67 diopters |
| Glasses- Younger Cohort | Mean Change in Spherical Equivalent (SE) Refractive Error (Diopters) | More Hyperopic Eye | 0.15 diopters |
| Glasses- Younger Cohort | Mean Change in Spherical Equivalent (SE) Refractive Error (Diopters) | Less Hyperopic Eye | 0.30 diopters |
| Observation- Younger Cohort | Mean Change in Spherical Equivalent (SE) Refractive Error (Diopters) | More Hyperopic Eye | -0.01 diopters |
| Observation- Younger Cohort | Mean Change in Spherical Equivalent (SE) Refractive Error (Diopters) | Less Hyperopic Eye | 0.08 diopters |
Comparison: Analysis for the more hyperopic eye, Older Cohort:~An analysis of covariance model adjusting for refractive error at enrollment was used to compare mean change in refractive error between treatment groups.p-value: 0.00299% CI: [0.11, 1.09]ANCOVA
Comparison: Analysis for the less hyperopic eye, Older Cohort:~An analysis of covariance model adjusting for refractive error at enrollment was used to compare mean change in refractive error between treatment groups.p-value: 0.00299% CI: [0.1, 1.06]ANCOVA
Comparison: Analysis for the more hyperopic eye, Younger Cohort:~An analysis of covariance model adjusting for refractive error at enrollment was used to compare mean change in refractive error between treatment groups.p-value: 0.5399% CI: [-0.51, 0.84]ANCOVA
Comparison: Analysis for the less hyperopic eye, Younger Cohort:~An analysis of covariance model adjusting for refractive error at enrollment was used to compare mean change in refractive error between treatment groups.p-value: 0.3899% CI: [-0.43, 0.86]ANCOVA
Secondary
Mean Stereoacuity
Mean stereoacuity at 3 years was measured in log seconds of arc (log arcsec) (see explanation below). Evaluated the best of the values reported with and without trial frames, during initial assessment and retest. Stereoacuity scores (seconds of arc) were calculated based on the Randot Preschool stereoacuity test (scores: 800, 400, 200, 100, 60 and 40). Seconds of arc refers to the visual angle that is being measured in order to determine depth perception. Lower scores indicate better stereoacuity. A logarithm base 10 transformation was used to convert stereoacuity scores to the log scale to calculate descriptive statistics (reported as seconds of arc, or arcsec). Seconds of arc were converted to logarithm of seconds of arc, or log arcsec (in parentheses) as follows: 40 (1.60), 60(1.78), 100 (2.00), 200 (2.30), 400 (2.60), 800 (2.90), Nil (3.20)
Time frame: 36 months
Population: Overall number is the total number of patients who completed the 3-year study.
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| Glasses- Older Cohort | Mean Stereoacuity | 1.76 logarithm of seconds of arc (log arcsec) | Standard Deviation 0.2 |
| Observation- Older Cohort | Mean Stereoacuity | 1.75 logarithm of seconds of arc (log arcsec) | Standard Deviation 0.23 |
| Glasses- Younger Cohort | Mean Stereoacuity | 2.2 logarithm of seconds of arc (log arcsec) | Standard Deviation 0.52 |
| Observation- Younger Cohort | Mean Stereoacuity | 2.3 logarithm of seconds of arc (log arcsec) | Standard Deviation 0.55 |
Comparison: An analysis of covariance model was used to compare mean change in stereoacuity between treatment groups. The analysis controlled for age at the 3-year visit, anisometropia at the most recent visit, and stereoacuity at enrollment.p-value: 0.7499% CI: [-0.11, 0.14]ANCOVA
Comparison: An analysis of covariance model was used to compare mean change in stereoacuity between treatment groups. The analysis controlled for age at the 3-year visit and anisometropia at the most recent visit.p-value: 0.1599% CI: [-0.4, 0.1]ANCOVA
Secondary
Number of Participants With Strabismus at 3 Years
The number of participants who developed measurable heterotropia was estimated for each treatment group and the proportions were compared using Barnard's exact test.
Time frame: 36 months after randomization
Population: In the older cohort, one participant had esotropia. In the younger cohort, Three participants in the glasses group and two in the observation group received strabismus surgery prior to the 3-year visit. These participants are included in the table.
| Arm | Measure | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|
| Glasses- Older Cohort | Number of Participants With Strabismus at 3 Years | 0 Participants |
| Observation- Older Cohort | Number of Participants With Strabismus at 3 Years | 1 Participants |
| Glasses- Younger Cohort | Number of Participants With Strabismus at 3 Years | 5 Participants |
| Observation- Younger Cohort | Number of Participants With Strabismus at 3 Years | 5 Participants |
Comparison: Barnard's exact test used to compare proportions between treatment groupsp-value: 0.5199% CI: [-18, 13]Barnard's Exact Test
Comparison: Barnard's exact test used to compare proportions between treatment groups.99% CI: [-17, 17]
Secondary
Percentage of Participants With Hyperopia Reduction
Percentage of Participants (%) in which hyperopia reduced by 1.00D (diopters) or more over 3 years
Time frame: Enrollment to 3 years
Population: Overall number is the number of patients that completed the 3-year study in the Older Cohort. This measure was not recorded for Younger Cohort.
| Arm | Measure | Group | Value (NUMBER) |
|---|---|---|---|
| Glasses- Older Cohort | Percentage of Participants With Hyperopia Reduction | More Hyperopic Eye | 17 percentage of participants |
| Glasses- Older Cohort | Percentage of Participants With Hyperopia Reduction | Less Hyperopic Eye | 20 percentage of participants |
| Observation- Older Cohort | Percentage of Participants With Hyperopia Reduction | More Hyperopic Eye | 42 percentage of participants |
| Observation- Older Cohort | Percentage of Participants With Hyperopia Reduction | Less Hyperopic Eye | 37 percentage of participants |
Comparison: Analysis for the more hyperopic eye:~Barnard's exact test was used to compare proportions between treatment groups.p-value: 0.01399% CI: [-49, 1]Barnard's Exact Test
Comparison: Analysis for the less hyperopic eye:~Barnard's exact test was used to compare proportions between treatment groups.p-value: 0.0899% CI: [-42, 8]Barnard's Exact Test
Secondary
Proportion With Amblyopia (at Distance)
A treatment group comparison of the proportion of subjects who developed amblyopia at distance during the course of the study will be performed using the Barnard's exact test. Participants were classified as having amblyopia if any of the following criteria were met: 1) the interocular difference was ≥2 logMAR lines of IOD if VA is 20/25 or worse in the better-seeing eye, or 2) the interocular differences was ≥3 logMAR lines of IOD if VA is 20/20 or better in the better-seeing eye. 3) VA less than age normal in each eye (presumed bilateral amblyopia)
Time frame: 36 months after randomization
Population: Overall number is the total number of patients who completed the 3-year study.
| Arm | Measure | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|
| Glasses- Older Cohort | Proportion With Amblyopia (at Distance) | 0 Participants |
| Observation- Older Cohort | Proportion With Amblyopia (at Distance) | 1 Participants |
| Glasses- Younger Cohort | Proportion With Amblyopia (at Distance) | 7 Participants |
| Observation- Younger Cohort | Proportion With Amblyopia (at Distance) | 9 Participants |
Comparison: Barnard's exact test was used to compare proportions between treatment groups.p-value: 0.5199% CI: [-18, 13]Barnard's Exact Test
Comparison: Barnard's exact test was used to compare proportions between treatment groups.p-value: 0.6899% CI: [-24, 16]Barnard's Exact Test
Secondary
Subgroup Analysis - Family History of Amblyopia
Treatment effect in subgroups based on baseline factors will be assessed. Outcome failure status at 36 months will be tabulated by subgroup and reviewed for consistency. Total number of patients who experienced failure at 3 years are shown.
Time frame: 36 months
Population: Total number that experienced failure, as reported in primary outcome
| Arm | Measure | Group | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|---|
| Glasses- Older Cohort | Subgroup Analysis - Family History of Amblyopia | Family History of Amblyopia- Yes | 3 Participants |
| Glasses- Older Cohort | Subgroup Analysis - Family History of Amblyopia | Family History of Amblyopia- No | 2 Participants |
| Observation- Older Cohort | Subgroup Analysis - Family History of Amblyopia | Family History of Amblyopia- No | 4 Participants |
| Observation- Older Cohort | Subgroup Analysis - Family History of Amblyopia | Family History of Amblyopia- Yes | 0 Participants |
| Glasses- Younger Cohort | Subgroup Analysis - Family History of Amblyopia | Family History of Amblyopia- Yes | 4 Participants |
| Glasses- Younger Cohort | Subgroup Analysis - Family History of Amblyopia | Family History of Amblyopia- No | 7 Participants |
| Observation- Younger Cohort | Subgroup Analysis - Family History of Amblyopia | Family History of Amblyopia- Yes | 6 Participants |
| Observation- Younger Cohort | Subgroup Analysis - Family History of Amblyopia | Family History of Amblyopia- No | 12 Participants |
Secondary
Subgroup Analysis - Family History of Strabismus
Treatment effect in subgroups based on baseline factors will be assessed. Outcome failure status at 36 months will be tabulated by subgroup and reviewed for consistency. Total number of patients who experienced failure at 3 years are shown.
Time frame: 36 months
Population: Total number that experienced failure, as reported in primary outcome
| Arm | Measure | Group | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|---|
| Glasses- Older Cohort | Subgroup Analysis - Family History of Strabismus | Family History of Strabismus- No | 2 Participants |
| Glasses- Older Cohort | Subgroup Analysis - Family History of Strabismus | Family History of Strabismus- Yes | 3 Participants |
| Observation- Older Cohort | Subgroup Analysis - Family History of Strabismus | Family History of Strabismus- No | 4 Participants |
| Observation- Older Cohort | Subgroup Analysis - Family History of Strabismus | Family History of Strabismus- Yes | 0 Participants |
| Glasses- Younger Cohort | Subgroup Analysis - Family History of Strabismus | Family History of Strabismus- No | 6 Participants |
| Glasses- Younger Cohort | Subgroup Analysis - Family History of Strabismus | Family History of Strabismus- Yes | 5 Participants |
| Observation- Younger Cohort | Subgroup Analysis - Family History of Strabismus | Family History of Strabismus- No | 11 Participants |
| Observation- Younger Cohort | Subgroup Analysis - Family History of Strabismus | Family History of Strabismus- Yes | 7 Participants |
Secondary
Subgroup Analysis - Gender
Treatment effect in subgroups based on baseline factors will be assessed. Outcome failure status at 36 months will be tabulated by subgroup and reviewed for consistency. Total number of patients who experienced failure at 3 years are shown.
Time frame: 36 months
Population: Total number that experienced failure, as reported in primary outcome
| Arm | Measure | Group | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|---|
| Glasses- Older Cohort | Subgroup Analysis - Gender | Gender - Male | 1 Participants |
| Glasses- Older Cohort | Subgroup Analysis - Gender | Gender- Female | 4 Participants |
| Observation- Older Cohort | Subgroup Analysis - Gender | Gender - Male | 1 Participants |
| Observation- Older Cohort | Subgroup Analysis - Gender | Gender- Female | 3 Participants |
| Glasses- Younger Cohort | Subgroup Analysis - Gender | Gender- Female | 4 Participants |
| Glasses- Younger Cohort | Subgroup Analysis - Gender | Gender - Male | 7 Participants |
| Observation- Younger Cohort | Subgroup Analysis - Gender | Gender- Female | 10 Participants |
| Observation- Younger Cohort | Subgroup Analysis - Gender | Gender - Male | 8 Participants |
Secondary
Subgroup Analysis - Mean Refractive Error at Enrollment (Diopters)
Treatment effect in subgroups based on baseline factors will be assessed. Outcome failure status at 36 months will be tabulated by subgroup and reviewed for consistency. Total number of patients who experienced failure at 3 years are shown.
Time frame: 36 months
Population: Total number that experienced failure, as reported in primary outcome
| Arm | Measure | Group | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|---|
| Glasses- Older Cohort | Subgroup Analysis - Mean Refractive Error at Enrollment (Diopters) | +2.50D to <+4.00D | 3 Participants |
| Glasses- Older Cohort | Subgroup Analysis - Mean Refractive Error at Enrollment (Diopters) | +5.00D to +6.00D | 1 Participants |
| Glasses- Older Cohort | Subgroup Analysis - Mean Refractive Error at Enrollment (Diopters) | +4.00D to <+5.00D | 1 Participants |
| Observation- Older Cohort | Subgroup Analysis - Mean Refractive Error at Enrollment (Diopters) | +2.50D to <+4.00D | 2 Participants |
| Observation- Older Cohort | Subgroup Analysis - Mean Refractive Error at Enrollment (Diopters) | +5.00D to +6.00D | 1 Participants |
| Observation- Older Cohort | Subgroup Analysis - Mean Refractive Error at Enrollment (Diopters) | +4.00D to <+5.00D | 1 Participants |
| Glasses- Younger Cohort | Subgroup Analysis - Mean Refractive Error at Enrollment (Diopters) | +4.00D to <+5.00D | 5 Participants |
| Glasses- Younger Cohort | Subgroup Analysis - Mean Refractive Error at Enrollment (Diopters) | +2.50D to <+4.00D | 2 Participants |
| Glasses- Younger Cohort | Subgroup Analysis - Mean Refractive Error at Enrollment (Diopters) | +5.00D to +6.00D | 4 Participants |
| Observation- Younger Cohort | Subgroup Analysis - Mean Refractive Error at Enrollment (Diopters) | +2.50D to <+4.00D | 6 Participants |
| Observation- Younger Cohort | Subgroup Analysis - Mean Refractive Error at Enrollment (Diopters) | +5.00D to +6.00D | 5 Participants |
| Observation- Younger Cohort | Subgroup Analysis - Mean Refractive Error at Enrollment (Diopters) | +4.00D to <+5.00D | 7 Participants |
Secondary
Subgroup Analysis - Race
Treatment effect in subgroups based on baseline factors will be assessed. Outcome failure status at 36 months will be tabulated by subgroup and reviewed for consistency. Total number of patients who experienced failure at 3 years are shown.
Time frame: 36 months after randomization
Population: Total number that experienced failure, as reported in primary outcome
| Arm | Measure | Group | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|---|
| Glasses- Older Cohort | Subgroup Analysis - Race | Race - Non-white | 2 Participants |
| Glasses- Older Cohort | Subgroup Analysis - Race | Race - White | 3 Participants |
| Observation- Older Cohort | Subgroup Analysis - Race | Race - White | 3 Participants |
| Observation- Older Cohort | Subgroup Analysis - Race | Race - Non-white | 1 Participants |
| Glasses- Younger Cohort | Subgroup Analysis - Race | Race - Non-white | 0 Participants |
| Glasses- Younger Cohort | Subgroup Analysis - Race | Race - White | 11 Participants |
| Observation- Younger Cohort | Subgroup Analysis - Race | Race - Non-white | 4 Participants |
| Observation- Younger Cohort | Subgroup Analysis - Race | Race - White | 14 Participants |
Secondary
Subgroup Analysis - SE Anisometropia
Treatment effect in subgroups based on baseline factors will be assessed. Outcome failure status at 36 months will be tabulated by subgroup and reviewed for consistency. Total number of patients who experienced failure at 3 years are shown.
Time frame: 36 months
Population: Total number that experienced failure, as reported in primary outcome
| Arm | Measure | Group | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|---|
| Glasses- Older Cohort | Subgroup Analysis - SE Anisometropia | +1.00D to +1.50D | 0 Participants |
| Glasses- Older Cohort | Subgroup Analysis - SE Anisometropia | +0.50D to <+1.00D | 2 Participants |
| Glasses- Older Cohort | Subgroup Analysis - SE Anisometropia | 0.00D to <+0.50D | 3 Participants |
| Observation- Older Cohort | Subgroup Analysis - SE Anisometropia | +1.00D to +1.50D | 0 Participants |
| Observation- Older Cohort | Subgroup Analysis - SE Anisometropia | +0.50D to <+1.00D | 0 Participants |
| Observation- Older Cohort | Subgroup Analysis - SE Anisometropia | 0.00D to <+0.50D | 4 Participants |
| Glasses- Younger Cohort | Subgroup Analysis - SE Anisometropia | 0.00D to <+0.50D | 8 Participants |
| Glasses- Younger Cohort | Subgroup Analysis - SE Anisometropia | +0.50D to <+1.00D | 2 Participants |
| Glasses- Younger Cohort | Subgroup Analysis - SE Anisometropia | +1.00D to +1.50D | 1 Participants |
| Observation- Younger Cohort | Subgroup Analysis - SE Anisometropia | +0.50D to <+1.00D | 1 Participants |
| Observation- Younger Cohort | Subgroup Analysis - SE Anisometropia | 0.00D to <+0.50D | 14 Participants |
| Observation- Younger Cohort | Subgroup Analysis - SE Anisometropia | +1.00D to +1.50D | 3 Participants |