Hyperopia Treatment Study 1 (HTS1) - Glasses vs Observation

• Sponsor: Jaeb Center for Health Research (Other)
• Overall Status: Completed
• CT.gov ID: NCT01515475
• Collaborator: Pediatric Eye Disease Investigator Group (Other), National Eye Institute (NEI) (NIH)
• Enrollment: 249
• Locations: 2
• Arms: 2
• Actual Duration (Months): 71.3
• Patients Per Site: 124.5
• Patients Per Site Per Month: 1.7

Study Details

Study Description

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.

Condition or Disease	Intervention/Treatment	Phase
Hyperopia	Procedure: Glasses	N/A

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.

Study Design

• Study Type: Interventional
• Actual Enrollment: 249 participants
• Allocation: Randomized
• Intervention Model: Parallel Assignment
• Masking: Single (Outcomes Assessor)
• Primary Purpose: Treatment
• Official Title: Glasses Versus Observation for Moderate Hyperopia in Young Children (HTS1)
• Actual Study Start Date: Feb 23, 2012
• Actual Primary Completion Date: Feb 1, 2018
• Actual Study Completion Date: Feb 1, 2018

Arms and Interventions

Arm	Intervention/Treatment
Active Comparator: Glasses Glasses are prescribed at enrollment and worn per protocol throughout the duration of the study.	Procedure: Glasses; Glasses will be prescribed at enrollment with the sphere cut symmetrically by 1.00D and full cylinder correction.
Placebo Comparator: Observation Glasses will not be prescribed unless the patient has confirmation of one or more deterioration criteria as described in the protocol.	Procedure: Glasses; Glasses will be prescribed at enrollment with the sphere cut symmetrically by 1.00D and full cylinder correction.

Outcome Measures

Primary Outcome Measures

1. 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 Any measurable manifest strabismus in primary gaze at distance or at near not correctable with distance refractive correction alone Strabismus surgery prior to the 36-month exam Distance VA below age norms in either eye ≥2 logMAR lines of IOD if VA is 20/25 or worse in the better-seeing eye ≥3 logMAR lines of IOD if VA is 20/20 or better in the better-seeing eye Stereoacuity measured at near below age normal values

Secondary Outcome Measures

1. 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.

2. 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.

3. 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.

4. 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.

5. 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.

6. 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.

7. 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.

8. 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.

9. 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

10. 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.

11. 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.

12. 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)

13. 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.

14. 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.

15. 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)

16. 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.

Eligibility Criteria

Criteria

• Ages Eligible for Study: 12 Months to 71 Months
• Sexes Eligible for Study: All
• Accepts 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:

6. 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

7. Zero (0) or 1 logMAR line interocular difference (IOD) in uncorrected visual acuity measured without cycloplegia using the ATS-HOTV© visual acuity testing protocol

8. Age-normal stereoacuity on the Randot Preschool Stereotest (see Table 2 of protocol)

9. Gestational age >32 weeks

10. 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.

11. 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.

12. Parent has phone (or access to phone) and is willing to be contacted by Jaeb Center staff.

13. 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

Contacts and Locations

Locations

	Site	City	State	Country	Postal Code
1	The Ohio State University College of Optometry	Columbus	Ohio	United States	43210-1280
2	Rocky Mountain Eye Care Associates	Salt Lake City	Utah	United States	84107

Sponsors and Collaborators

• Jaeb Center for Health Research
• Pediatric Eye Disease Investigator Group
• National Eye Institute (NEI)

Investigators

• Study Chair: Marjean Kulp, OD, MS, Jaeb Center for Health Research
• Study Chair: David Petersen, MD, Jaeb Center for Health Research

Study Documents (Full-Text)

• Informed Consent Form - Oct 14, 2013
• Statistical Analysis Plan - Jul 25, 2018
• Study Protocol - Jan 28, 2015

More Information

Publications

• Pediatric Eye Disease Investigator Group. Clinical factors associated with moderate hyperopia in preschool children with normal stereopsis and visual acuity. J AAPOS. 2016 Oct;20(5):455-457. doi: 10.1016/j.jaapos.2016.04.012. Epub 2016 Sep 20.

• Responsible Party: Jaeb Center for Health Research
• ClinicalTrials.gov Identifier: NCT01515475
• Other Study ID Numbers: HTS1; 2U10EY011751
• First Posted: Jan 24, 2012
• Last Update Posted: Jul 16, 2019
• Last Verified: Jul 1, 2019

• Individual Participant Data (IPD) Sharing Statement: Yes
• Plan to Share IPD: Yes
• Keywords provided by Jaeb Center for Health Research: Hyperopia; Glasses
• Additional relevant MeSH terms: Hyperopia

Study Results

Participant Flow

Arm/Group Title	Glasses- Older Cohort	Observation- Older Cohort	Glasses- Younger Cohort	Observation- Younger Cohort
Arm/Group Description	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.	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.	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.	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.
Period Title: Overall Study
STARTED	61	58	65	65
COMPLETED	41	43	53	53
NOT COMPLETED	20	15	12	12

Baseline Characteristics

Arm/Group Title	Glasses- Older Cohort	Observation- Older Cohort	Glasses- Younger Cohort	Observation- Younger Cohort	Total
Arm/Group Description	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.	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.	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.	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.	Total of all reporting groups
Overall Participants	61	58	65	65	249
Age (Count of Participants)
<=18 years	61 100%	58 100%	65 100%	65 100%	249 100%
Between 18 and 65 years	0 0%	0 0%	0 0%	0 0%	0 0%
>=65 years	0 0%	0 0%	0 0%	0 0%	0 0%
Age, Customized (Count of Participants)
1 Year	0 0%	0 0%	42 64.6%	42 64.6%	84 33.7%
2 Years	0 0%	0 0%	23 35.4%	23 35.4%	46 18.5%
3 Years	19 31.1%	20 34.5%	0 0%	0 0%	39 15.7%
4 Years	31 50.8%	30 51.7%	0 0%	0 0%	61 24.5%
5 Years	11 18%	8 13.8%	0 0%	0 0%	19 7.6%
Sex: Female, Male (Count of Participants)
Female	38 62.3%	32 55.2%	33 50.8%	35 53.8%	138 55.4%
Male	23 37.7%	26 44.8%	32 49.2%	30 46.2%	111 44.6%
Race/Ethnicity, Customized (Count of Participants)
Asian	2 3.3%	0 0%	1 1.5%	0 0%	3 1.2%
Black/African American	12 19.7%	14 24.1%	2 3.1%	3 4.6%	31 12.4%
Hispanic	13 21.3%	7 12.1%	7 10.8%	8 12.3%	35 14.1%
White	34 55.7%	35 60.3%	53 81.5%	52 80%	174 69.9%
More than one race	0 0%	1 1.7%	2 3.1%	2 3.1%	5 2%
Unknown/Not reported	0 0%	1 1.7%	0 0%	0 0%	1 0.4%
Family History of Amblyopia (Count of Participants)
Count of Participants [Participants]	16 26.2%	17 29.3%	21 32.3%	20 30.8%	74 29.7%
Family History of Strabismus (Count of Participants)
Count of Participants [Participants]	11 18%	16 27.6%	26 40%	25 38.5%	78 31.3%
Diagnosis Of ADHD (Count of Participants)
Count of Participants [Participants]	0 0%	0 0%	0 0%	0 0%	0 0%
SE Refractive Error: More hyperopic eye (Count of Participants)
+2.00D to <+3.00D	0 0%	0 0%	0 0%	0 0%	0 0%
+3.00D to <+4.00D	37 60.7%	32 55.2%	25 38.5%	20 30.8%	114 45.8%
+4.00D to <+5.00D	16 26.2%	19 32.8%	19 29.2%	27 41.5%	81 32.5%
+5.00D to +6.00D	8 13.1%	7 12.1%	20 30.8%	13 20%	48 19.3%
+6.00 to +7.00 D	0 0%	0 0%	1 1.5%	5 7.7%	6 2.4%
+1.00 to <+2.00 D	0 0%	0 0%	0 0%	0 0%	0 0%
SE Refractive Error: More hyperopic eye (diopters (D)) [Mean (Standard Deviation) ]
Mean (Standard Deviation) [diopters (D)]	3.93 (0.71)	3.94 (0.74)	4.32 (0.85)	4.37 (0.87)	4.15 (0.82)
SE Refractive Error: Less hyperopic eye (Count of Participants)
+1.00 to <+2.00 D	0 0%	0 0%	0 0%	1 1.5%	1 0.4%
+2.00 to <+3.00D	10 16.4%	10 17.2%	4 6.2%	2 3.1%	26 10.4%
+3.00 to <+4.00D	34 55.7%	30 51.7%	26 40%	27 41.5%	117 47%
+4.00 to <+5.00D	12 19.7%	13 22.4%	22 33.8%	21 32.3%	68 27.3%
+5.00 to <+6.00D	5 8.2%	5 8.6%	13 20%	11 16.9%	34 13.7%
+6.00 to <+7.00D	0 0%	0 0%	0 0%	3 4.6%	3 1.2%
SE Refractive Error: Less hyperopic eye (diopters (D)) [Mean (Standard Deviation) ]
Mean (Standard Deviation) [diopters (D)]	3.60 (0.78)	3.59 (0.81)	4.04 (0.85)	4.07 (0.90)	3.84 (0.86)
Anisometropia (Count of Participants)
0.00 to <+0.50	42 68.9%	39 67.2%	47 72.3%	46 70.8%	174 69.9%
+0.50D to <+1.00D	16 26.2%	14 24.1%	13 20%	12 18.5%	55 22.1%
+1.00D to +1.50D	3 4.9%	5 8.6%	5 7.7%	7 10.8%	20 8%
Anisometropia (diopters (D)) [Mean (Standard Deviation) ]
Mean (Standard Deviation) [diopters (D)]	0.33 (0.36)	0.34 (0.34)	0.28 (0.38)	0.30 (0.39)	0.31 (0.37)
Astigmatism: More astigmatic eye (Count of Participants)
0.00D to <+0.50D	29 47.5%	29 50%	36 55.4%	29 44.6%	123 49.4%
+0.50D to <+1.00D	23 37.7%	18 31%	18 27.7%	19 29.2%	78 31.3%
+1.00D to +1.50D	9 14.8%	11 19%	11 16.9%	17 26.2%	48 19.3%
Astigmatism: More astigmatic eye (diopters (D)) [Mean (Standard Deviation) ]
Mean (Standard Deviation) [diopters (D)]	0.45 (0.45)	0.44 (0.44)	0.40 (0.48)	0.49 (0.48)	0.45 (0.46)
Astigmatism: Less astigmatic eye (Count of Participants)
0.00D to <+0.50D	40 65.6%	41 70.7%	41 63.1%	39 60%	161 64.7%
+0.50D to <+1.00D	14 23%	12 20.7%	17 26.2%	13 20%	56 22.5%
+1.00D to +1.50D	7 11.5%	5 8.6%	7 10.8%	13 20%	32 12.9%
Astigmatism: Less astigmatic eye (diopters (D)) [Mean (Standard Deviation) ]
Mean (Standard Deviation) [diopters (D)]	0.32 (0.42)	0.25 (0.36)	0.27 (0.38)	0.37 (0.47)	0.31 (0.41)
Distance Visual Acuity: Better-seeing Eye (Count of Participants)
20/16	5 8.2%	3 5.2%	8 12.3%
20/20	16 26.2%	18 31%	34 52.3%
20/25	25 41%	18 31%	43 66.2%
20/32	9 14.8%	13 22.4%	22 33.8%
20/40	6 9.8%	6 10.3%	12 18.5%
20/50	0 0%	0 0%	0 0%
Distance Visual Acuity: Better-seeing Eye (logMAR) [Mean (Standard Deviation) ]
Mean (Standard Deviation) [logMAR]	0.09 (0.11)	0.10 (0.11)	0.10 (0.11)
Distance Visual Acuity: Worse-seeing Eye (Count of Participants)
20/16	2 3.3%	0 0%	2 3.1%
20/20	7 11.5%	7 12.1%	14 21.5%
20/25	26 42.6%	25 43.1%	51 78.5%
20/32	15 24.6%	15 25.9%	30 46.2%
20/40	8 13.1%	9 15.5%	17 26.2%
20/50	3 4.9%	2 3.4%	5 7.7%
Distance Visual Acuity: Worse-seeing Eye (logMAR) [Mean (Standard Deviation) ]
Mean (Standard Deviation) [logMAR]	0.15 (0.11)	0.16 (0.10)	0.15 (0.11)
Stereoacuity at Near (Count of Participants)
40	9 14.8%	7 12.1%	16 24.6%
60	21 34.4%	12 20.7%	33 50.8%
100	13 21.3%	15 25.9%	28 43.1%
200	12 19.7%	16 27.6%	28 43.1%
400	6 9.8%	6 10.3%	12 18.5%
Nil	0 0%	1 1.7%	1 1.5%
Failed pretest	0 0%	1 1.7%	1 1.5%
Stereoacuity at Near (seconds of arc (arcsec)) [Median (Full Range) ]
Median (Full Range) [seconds of arc (arcsec)]	100	100	100

Outcome Measures

1. Primary Outcome

Title	Number of Participants With Confirmation of Failure Criteria
Description	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 Any measurable manifest strabismus in primary gaze at distance or at near not correctable with distance refractive correction alone Strabismus surgery prior to the 36-month exam Distance VA below age norms in either eye ≥2 logMAR lines of IOD if VA is 20/25 or worse in the better-seeing eye ≥3 logMAR lines of IOD if VA is 20/20 or better in the better-seeing eye Stereoacuity measured at near below age normal values
Time Frame	36 months after randomization

Outcome Measure Data

Analysis Population Description

Overall number is the number of patients who completed the entire study.

Arm/Group Title	Glasses- Older Cohort	Observation- Older Cohort	Glasses- Younger Cohort	Observation- Younger Cohort
Arm/Group Description	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.	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.	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.	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.
Measure Participants	41	43	53	53
Count of Participants [Participants]	5 8.2%	4 6.9%	11 16.9%	18 27.7%

Statistical Analysis 1

Statistical Analysis Overview	Comparison Group Selection	Glasses- Older Cohort, Observation- Older Cohort
	Comments
	Type of Statistical Test	Other
	Comments
Statistical Test of Hypothesis	p-Value	0.72
	Comments
	Method	Barnard's Exact Test
	Comments
Method of Estimation	Estimation Parameter	Risk Difference (RD)
	Estimated Value	3
	Confidence Interval	(2-Sided) 95%; -12 to 18
	Parameter Dispersion	Type: Value:
	Estimation Comments

Statistical Analysis 2

Statistical Analysis Overview	Comparison Group Selection	Glasses- Younger Cohort, Observation- Younger Cohort
	Comments
	Type of Statistical Test	Other
	Comments
Statistical Test of Hypothesis	p-Value	0.14
	Comments
	Method	Barnard's Exact Test
	Comments
Method of Estimation	Estimation Parameter	Risk Difference (RD)
	Estimated Value	-13
	Confidence Interval	(2-Sided) 95%; -31 to 4
	Parameter Dispersion	Type: Value:
	Estimation Comments

2. Secondary Outcome

Title	Subgroup Analysis - Race
Description	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

Outcome Measure Data

Analysis Population Description

Total number that experienced failure, as reported in primary outcome

Arm/Group Title	Glasses- Older Cohort	Observation- Older Cohort	Glasses- Younger Cohort	Observation- Younger Cohort
Arm/Group Description	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.	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.	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.	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.
Measure Participants	5	4	11	18
Race - Non-white	2 3.3%	1 1.7%	0 0%	4 6.2%
Race - White	3 4.9%	3 5.2%	11 16.9%	14 21.5%

3. Secondary Outcome

Title	Subgroup Analysis - Gender
Description	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

Outcome Measure Data

Analysis Population Description

Total number that experienced failure, as reported in primary outcome

Arm/Group Title	Glasses- Older Cohort	Observation- Older Cohort	Glasses- Younger Cohort	Observation- Younger Cohort
Arm/Group Description	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.	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.	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.	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.
Measure Participants	5	4	11	18
Gender- Female	4 6.6%	3 5.2%	4 6.2%	10 15.4%
Gender - Male	1 1.6%	1 1.7%	7 10.8%	8 12.3%

4. Secondary Outcome

Title	Subgroup Analysis - Family History of Amblyopia
Description	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

Outcome Measure Data

Analysis Population Description

Total number that experienced failure, as reported in primary outcome

Arm/Group Title	Glasses- Older Cohort	Observation- Older Cohort	Glasses- Younger Cohort	Observation- Younger Cohort
Arm/Group Description	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.	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.	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.	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.
Measure Participants	5	4	11	18
Family History of Amblyopia- Yes	3 4.9%	0 0%	4 6.2%	6 9.2%
Family History of Amblyopia- No	2 3.3%	4 6.9%	7 10.8%	12 18.5%

5. Secondary Outcome

Title	Subgroup Analysis - Family History of Strabismus
Description	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

Outcome Measure Data

Analysis Population Description

Total number that experienced failure, as reported in primary outcome

Arm/Group Title	Glasses- Older Cohort	Observation- Older Cohort	Glasses- Younger Cohort	Observation- Younger Cohort
Arm/Group Description	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.	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.	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.	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.
Measure Participants	5	4	11	18
Family History of Strabismus- Yes	3 4.9%	0 0%	5 7.7%	7 10.8%
Family History of Strabismus- No	2 3.3%	4 6.9%	6 9.2%	11 16.9%

6. Secondary Outcome

Title	Subgroup Analysis - SE Anisometropia
Description	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

Outcome Measure Data

Analysis Population Description

Total number that experienced failure, as reported in primary outcome

Arm/Group Title	Glasses- Older Cohort	Observation- Older Cohort	Glasses- Younger Cohort	Observation- Younger Cohort
Arm/Group Description	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.	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.	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.	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.
Measure Participants	5	4	11	18
0.00D to <+0.50D	3 4.9%	4 6.9%	8 12.3%	14 21.5%
+0.50D to <+1.00D	2 3.3%	0 0%	2 3.1%	1 1.5%
+1.00D to +1.50D	0 0%	0 0%	1 1.5%	3 4.6%

7. Secondary Outcome

Title	Subgroup Analysis - Mean Refractive Error at Enrollment (Diopters)
Description	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

Outcome Measure Data

Analysis Population Description

Total number that experienced failure, as reported in primary outcome

Arm/Group Title	Glasses- Older Cohort	Observation- Older Cohort	Glasses- Younger Cohort	Observation- Younger Cohort
Arm/Group Description	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.	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.	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.	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.
Measure Participants	5	4	11	18
+2.50D to <+4.00D	3 4.9%	2 3.4%	2 3.1%	6 9.2%
+4.00D to <+5.00D	1 1.6%	1 1.7%	5 7.7%	7 10.8%
+5.00D to +6.00D	1 1.6%	1 1.7%	4 6.2%	5 7.7%

8. Secondary Outcome

Title	Deterioration Criteria Met (Prior to 3 Years)
Description	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

Outcome Measure Data

Analysis Population Description

[Not Specified]

Arm/Group Title	Glasses- Older Cohort	Observation- Older Cohort	Glasses- Younger Cohort	Observation- Younger Cohort
Arm/Group Description	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.	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.	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.	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.
Measure Participants	61	58	65	65
Count of Participants [Participants]	16 26.2%	14 24.1%	20 30.8%	36 55.4%

9. Secondary Outcome

Title	Mean Change in Spherical Equivalent (SE) Refractive Error (Diopters)
Description	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

Outcome Measure Data

Analysis Population Description

Overall number is the total number of patients who completed the 3-year study.

Arm/Group Title	Glasses- Older Cohort	Observation- Older Cohort	Glasses- Younger Cohort	Observation- Younger Cohort
Arm/Group Description	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.	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.	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.	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.
Measure Participants	41	43	53	53
More Hyperopic Eye	-0.07	-0.67	0.15	-0.01
Less Hyperopic Eye	0	-0.58	0.30	0.08

Statistical Analysis 1

Statistical Analysis Overview	Comparison Group Selection	Glasses- Older Cohort, Observation- Older Cohort
	Comments	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.
	Type of Statistical Test	Other
	Comments
Statistical Test of Hypothesis	p-Value	0.002
	Comments	Results are considered statistically significant if p<0.01.
	Method	ANCOVA
	Comments
Method of Estimation	Estimation Parameter	Mean Difference (Final Values)
	Estimated Value	0.60
	Confidence Interval	(2-Sided) 99%; 0.11 to 1.09
	Parameter Dispersion	Type: Value:
	Estimation Comments

Statistical Analysis 2

Statistical Analysis Overview	Comparison Group Selection	Glasses- Older Cohort, Observation- Older Cohort
	Comments	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.
	Type of Statistical Test	Other
	Comments
Statistical Test of Hypothesis	p-Value	0.002
	Comments	Results are considered statistically significant if p<0.01.
	Method	ANCOVA
	Comments
Method of Estimation	Estimation Parameter	Mean Difference (Final Values)
	Estimated Value	0.58
	Confidence Interval	(2-Sided) 99%; 0.10 to 1.06
	Parameter Dispersion	Type: Value:
	Estimation Comments

Statistical Analysis 3

Statistical Analysis Overview	Comparison Group Selection	Glasses- Younger Cohort, Observation- Younger Cohort
	Comments	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.
	Type of Statistical Test	Other
	Comments
Statistical Test of Hypothesis	p-Value	0.53
	Comments	Results are considered statistically significant if p≤0.01.
	Method	ANCOVA
	Comments
Method of Estimation	Estimation Parameter	Mean Difference (Final Values)
	Estimated Value	0.16
	Confidence Interval	(2-Sided) 99%; -0.51 to 0.84
	Parameter Dispersion	Type: Value:
	Estimation Comments

Statistical Analysis 4

Statistical Analysis Overview	Comparison Group Selection	Glasses- Younger Cohort, Observation- Younger Cohort
	Comments	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.
	Type of Statistical Test	Other
	Comments
Statistical Test of Hypothesis	p-Value	0.38
	Comments	Results are considered statistically significant if p≤0.01.
	Method	ANCOVA
	Comments
Method of Estimation	Estimation Parameter	Mean Difference (Final Values)
	Estimated Value	0.22
	Confidence Interval	(2-Sided) 99%; -0.43 to 0.86
	Parameter Dispersion	Type: Value:
	Estimation Comments

10. Secondary Outcome

Title	Percentage of Participants With Hyperopia Reduction
Description	Percentage of Participants (%) in which hyperopia reduced by 1.00D (diopters) or more over 3 years
Time Frame	Enrollment to 3 years

Outcome Measure Data

Analysis Population Description

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/Group Title	Glasses- Older Cohort	Observation- Older Cohort
Arm/Group Description	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.	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.
Measure Participants	41	43
More Hyperopic Eye	17 27.9%	42 72.4%
Less Hyperopic Eye	20 32.8%	37 63.8%

Statistical Analysis 1

Statistical Analysis Overview	Comparison Group Selection	Glasses- Older Cohort, Observation- Older Cohort
	Comments	Analysis for the more hyperopic eye: Barnard's exact test was used to compare proportions between treatment groups.
	Type of Statistical Test	Other
	Comments
Statistical Test of Hypothesis	p-Value	0.013
	Comments	Results are considered statistically significant if p<0.01.
	Method	Barnard's Exact Test
	Comments
Method of Estimation	Estimation Parameter	Mean Difference (Final Values)
	Estimated Value	-25
	Confidence Interval	(2-Sided) 99%; -49 to 1
	Parameter Dispersion	Type: Value:
	Estimation Comments

Statistical Analysis 2

Statistical Analysis Overview	Comparison Group Selection	Glasses- Older Cohort, Observation- Older Cohort
	Comments	Analysis for the less hyperopic eye: Barnard's exact test was used to compare proportions between treatment groups.
	Type of Statistical Test	Other
	Comments
Statistical Test of Hypothesis	p-Value	0.08
	Comments	Results are considered statistically significant if p<0.01.
	Method	Barnard's Exact Test
	Comments
Method of Estimation	Estimation Parameter	Hazard Ratio, log
	Estimated Value	-18
	Confidence Interval	(2-Sided) 99%; -42 to 8
	Parameter Dispersion	Type: Value:
	Estimation Comments

11. Secondary Outcome

Title	Best Visual Acuity
Description	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

Outcome Measure Data

Analysis Population Description

[Not Specified]

Arm/Group Title	Glasses- Older Cohort	Observation- Older Cohort	Glasses- Younger Cohort	Observation- Younger Cohort
Arm/Group Description	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.	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.	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.	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.
Measure Participants	41	43	53	53
Better-seeing Eye	-0.06 (0.06)	-0.07 (0.05)	0.06 (0.12)	0.12 (0.13)
Worse-seeing Eye	-0.03 (0.08)	-0.01 (0.10)	0.16 (0.23)	0.23 (0.26)

Statistical Analysis 1

Statistical Analysis Overview	Comparison Group Selection	Glasses- Older Cohort, Observation- Older Cohort
	Comments	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.
	Type of Statistical Test	Other
	Comments
Statistical Test of Hypothesis	p-Value	0.22
	Comments
	Method	ANCOVA
	Comments
Method of Estimation	Estimation Parameter	Mean Difference (Final Values)
	Estimated Value	0.01
	Confidence Interval	(2-Sided) 99%; -0.02 to 0.04
	Parameter Dispersion	Type: Value:
	Estimation Comments

Statistical Analysis 2

Statistical Analysis Overview	Comparison Group Selection	Glasses- Older Cohort, Observation- Older Cohort
	Comments	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.
	Type of Statistical Test	Other
	Comments
Statistical Test of Hypothesis	p-Value	0.41
	Comments
	Method	ANCOVA
	Comments
Method of Estimation	Estimation Parameter	Mean Difference (Final Values)
	Estimated Value	-0.02
	Confidence Interval	(2-Sided) 99%; -0.06 to 0.03
	Parameter Dispersion	Type: Value:
	Estimation Comments

Statistical Analysis 3

Statistical Analysis Overview	Comparison Group Selection	Glasses- Younger Cohort, Observation- Younger Cohort
	Comments	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.
	Type of Statistical Test	Other
	Comments
Statistical Test of Hypothesis	p-Value	0.02
	Comments
	Method	ANCOVA
	Comments
Method of Estimation	Estimation Parameter	Mean Difference (Final Values)
	Estimated Value	-0.05
	Confidence Interval	(2-Sided) 99%; -0.12 to 0.01
	Parameter Dispersion	Type: Value:
	Estimation Comments

Statistical Analysis 4

Statistical Analysis Overview	Comparison Group Selection	Glasses- Younger Cohort, Observation- Younger Cohort
	Comments	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.
	Type of Statistical Test	Other
	Comments
Statistical Test of Hypothesis	p-Value	0.15
	Comments
	Method	ANCOVA
	Comments
Method of Estimation	Estimation Parameter	Mean Difference (Final Values)
	Estimated Value	-0.07
	Confidence Interval	(2-Sided) 99%; -0.19 to 0.05
	Parameter Dispersion	Type: Value:
	Estimation Comments

12. Secondary Outcome

Title	Failure to Meet Age-Normal VA at Distance
Description	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

Outcome Measure Data

Analysis Population Description

Overall number is the total number of patients who completed the 3-year study.

Arm/Group Title	Glasses- Older Cohort	Observation- Older Cohort	Glasses- Younger Cohort	Observation- Younger Cohort
Arm/Group Description	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.	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.	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.	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.
Measure Participants	41	43	53	53
Count of Participants [Participants]	0 0%	1 1.7%	3 4.6%	4 6.2%

Statistical Analysis 1

Statistical Analysis Overview	Comparison Group Selection	Glasses- Older Cohort, Observation- Older Cohort
	Comments	Barnard's exact test was used to compare proportions between treatment groups.
	Type of Statistical Test	Other
	Comments
Statistical Test of Hypothesis	p-Value	0.51
	Comments	Results are considered statistically significant if p<0.01.
	Method	Barnard's Exact Test
	Comments
Method of Estimation	Estimation Parameter	Mean Difference (Final Values)
	Estimated Value	-2
	Confidence Interval	(2-Sided) 99%; -18 to 13
	Parameter Dispersion	Type: Value:
	Estimation Comments

Statistical Analysis 2

Statistical Analysis Overview	Comparison Group Selection	Glasses- Younger Cohort, Observation- Younger Cohort
	Comments	Barnard's exact test was used to compare proportions between treatment groups.
	Type of Statistical Test	Other
	Comments
Statistical Test of Hypothesis	p-Value	0.79
	Comments	Results are considered statistically significant if p<0.01.
	Method	Barnard's Exact Test
	Comments
Method of Estimation	Estimation Parameter	Mean Difference (Final Values)
	Estimated Value	-2
	Confidence Interval	(2-Sided) 99%; -18 to 14
	Parameter Dispersion	Type: Value:
	Estimation Comments

13. Secondary Outcome

Title	Proportion With Amblyopia (at Distance)
Description	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

Outcome Measure Data

Analysis Population Description

Overall number is the total number of patients who completed the 3-year study.

Arm/Group Title	Glasses- Older Cohort	Observation- Older Cohort	Glasses- Younger Cohort	Observation- Younger Cohort
Arm/Group Description	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.	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.	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.	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.
Measure Participants	41	43	53	53
Count of Participants [Participants]	0 0%	1 1.7%	7 10.8%	9 13.8%

Statistical Analysis 1

Statistical Analysis Overview	Comparison Group Selection	Glasses- Older Cohort, Observation- Older Cohort
	Comments	Barnard's exact test was used to compare proportions between treatment groups.
	Type of Statistical Test	Other
	Comments
Statistical Test of Hypothesis	p-Value	0.51
	Comments	Results are considered statistically significant if p<0.01.
	Method	Barnard's Exact Test
	Comments
Method of Estimation	Estimation Parameter	Mean Difference (Final Values)
	Estimated Value	-2
	Confidence Interval	(2-Sided) 99%; -18 to 13
	Parameter Dispersion	Type: Value:
	Estimation Comments

Statistical Analysis 2

Statistical Analysis Overview	Comparison Group Selection	Glasses- Younger Cohort, Observation- Younger Cohort
	Comments	Barnard's exact test was used to compare proportions between treatment groups.
	Type of Statistical Test	Other
	Comments
Statistical Test of Hypothesis	p-Value	0.68
	Comments	Results are considered statistically significant if p≤0.01.
	Method	Barnard's Exact Test
	Comments
Method of Estimation	Estimation Parameter	Mean Difference (Final Values)
	Estimated Value	-4
	Confidence Interval	(2-Sided) 99%; -24 to 16
	Parameter Dispersion	Type: Value:
	Estimation Comments

14. Secondary Outcome

Title	Binocular Near Visual Acuity
Description	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

Outcome Measure Data

Analysis Population Description

Overall number is the total number of patients who completed the 3-year study.

Arm/Group Title	Glasses- Older Cohort	Observation- Older Cohort	Glasses- Younger Cohort	Observation- Younger Cohort
Arm/Group Description	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.	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.	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.	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.
Measure Participants	41	43	53	53
Mean (Standard Deviation) [logMAR]	0.01 (0.04)	0.04 (0.14)	0.09 (0.11)	0.12 (0.12)

Statistical Analysis 1

Statistical Analysis Overview	Comparison Group Selection	Glasses- Older Cohort, Observation- Older Cohort
	Comments	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.
	Type of Statistical Test	Other
	Comments
Statistical Test of Hypothesis	p-Value	0.21
	Comments	Results are considered statistically significant if p<0.01
	Method	ANCOVA
	Comments
Method of Estimation	Estimation Parameter	Mean Difference (Final Values)
	Estimated Value	-0.04
	Confidence Interval	(2-Sided) 99%; -0.12 to 0.05
	Parameter Dispersion	Type: Value:
	Estimation Comments

Statistical Analysis 2

Statistical Analysis Overview	Comparison Group Selection	Glasses- Younger Cohort, Observation- Younger Cohort
	Comments	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.
	Type of Statistical Test	Other
	Comments
Statistical Test of Hypothesis	p-Value	0.25
	Comments	Results are considered statistically significant if p≤0.01.
	Method	ANCOVA
	Comments
Method of Estimation	Estimation Parameter	Mean Difference (Final Values)
	Estimated Value	-0.03
	Confidence Interval	(2-Sided) 99%; -0.10 to 0.04
	Parameter Dispersion	Type: Value:
	Estimation Comments

15. Secondary Outcome

Title	Number of Participants With Strabismus at 3 Years
Description	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

Outcome Measure Data

Analysis Population Description

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/Group Title	Glasses- Older Cohort	Observation- Older Cohort	Glasses- Younger Cohort	Observation- Younger Cohort
Arm/Group Description	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.	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.	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.	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.
Measure Participants	41	43	53	53
Count of Participants [Participants]	0 0%	1 1.7%	5 7.7%	5 7.7%

Statistical Analysis 1

Statistical Analysis Overview	Comparison Group Selection	Glasses- Older Cohort, Observation- Older Cohort
	Comments	Barnard's exact test used to compare proportions between treatment groups
	Type of Statistical Test	Other
	Comments
Statistical Test of Hypothesis	p-Value	0.51
	Comments	Results are considered statistically significant if p<0.01.
	Method	Barnard's Exact Test
	Comments
Method of Estimation	Estimation Parameter	Mean Difference (Final Values)
	Estimated Value	-2
	Confidence Interval	(2-Sided) 99%; -18 to 13
	Parameter Dispersion	Type: Value:
	Estimation Comments

Statistical Analysis 2

Statistical Analysis Overview	Comparison Group Selection	Glasses- Younger Cohort, Observation- Younger Cohort
	Comments	Barnard's exact test used to compare proportions between treatment groups.
	Type of Statistical Test	Other
	Comments
Statistical Test of Hypothesis	p-Value
	Comments
	Method
	Comments
Method of Estimation	Estimation Parameter	Mean Difference (Final Values)
	Estimated Value	0
	Confidence Interval	(2-Sided) 99%; -17 to 17
	Parameter Dispersion	Type: Value:
	Estimation Comments

16. Secondary Outcome

Title	Mean Stereoacuity
Description	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

Outcome Measure Data

Analysis Population Description

Overall number is the total number of patients who completed the 3-year study.

Arm/Group Title	Glasses- Older Cohort	Observation- Older Cohort	Glasses- Younger Cohort	Observation- Younger Cohort
Arm/Group Description	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.	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.	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.	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.
Measure Participants	41	43	53	53
Mean (Standard Deviation) [logarithm of seconds of arc (log arcsec)]	1.76 (0.20)	1.75 (0.23)	2.2 (0.52)	2.3 (0.55)

Statistical Analysis 1

Statistical Analysis Overview	Comparison Group Selection	Glasses- Older Cohort, Observation- Older Cohort
	Comments	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.
	Type of Statistical Test	Other
	Comments
Statistical Test of Hypothesis	p-Value	0.74
	Comments	Results are considered statistically significant if p<0.01.
	Method	ANCOVA
	Comments
Method of Estimation	Estimation Parameter	Mean Difference (Final Values)
	Estimated Value	0.02
	Confidence Interval	(2-Sided) 99%; -0.11 to 0.14
	Parameter Dispersion	Type: Value:
	Estimation Comments

Statistical Analysis 2

Statistical Analysis Overview	Comparison Group Selection	Glasses- Younger Cohort, Observation- Younger Cohort
	Comments	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.
	Type of Statistical Test	Other
	Comments
Statistical Test of Hypothesis	p-Value	0.15
	Comments
	Method	ANCOVA
	Comments
Method of Estimation	Estimation Parameter	Mean Difference (Final Values)
	Estimated Value	-0.1
	Confidence Interval	(2-Sided) 99%; -0.4 to 0.1
	Parameter Dispersion	Type: Value:
	Estimation Comments

17. Secondary Outcome

Title	Failure to Meet Age-Normal Stereoacuity at 3 Years
Description	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

Outcome Measure Data

Analysis Population Description

Overall number is the total number of patients who completed the 3-year study.

Arm/Group Title	Glasses- Older Cohort	Observation- Older Cohort	Glasses- Younger Cohort	Observation- Younger Cohort
Arm/Group Description	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.	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.	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.	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.
Measure Participants	41	43	53	53
Count of Participants [Participants]	5 8.2%	3 5.2%	6 9.2%	16 24.6%

Statistical Analysis 1

Statistical Analysis Overview	Comparison Group Selection	Glasses- Older Cohort, Observation- Older Cohort
	Comments	Barnard's exact test used to compare proportions between treatment groups
	Type of Statistical Test	Other
	Comments
Statistical Test of Hypothesis	p-Value	0.53
	Comments	Results are considered statistically significant if p<0.01.
	Method	Barnard's Exact Test
	Comments
Method of Estimation	Estimation Parameter	Mean Difference (Final Values)
	Estimated Value	5
	Confidence Interval	(2-Sided) 99%; -14 to 26
	Parameter Dispersion	Type: Value:
	Estimation Comments

Statistical Analysis 2

Statistical Analysis Overview	Comparison Group Selection	Glasses- Younger Cohort, Observation- Younger Cohort
	Comments	Barnard's exact test used to compare proportions between treatment groups.
	Type of Statistical Test	Other
	Comments
Statistical Test of Hypothesis	p-Value	0.02
	Comments	Results are considered statistically significant if p<0.01.
	Method	Barnard's Exact Test
	Comments
Method of Estimation	Estimation Parameter	Mean Difference (Final Values)
	Estimated Value	-19
	Confidence Interval	(2-Sided) 99%; -40 to 2
	Parameter Dispersion	Type: Value:
	Estimation Comments

Adverse Events

Time Frame	3 Years (36 months)
Arm/Group Title	Glasses- Older Cohort		Observation- Older Cohort		Glasses- Younger Cohort		Observation- Younger Cohort
Arm/Group Description	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.		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.		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.		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.
All Cause Mortality
	Glasses- Older Cohort		Observation- Older Cohort		Glasses- Younger Cohort		Observation- Younger Cohort
	Affected / at Risk (%)	# Events	Affected / at Risk (%)	# Events	Affected / at Risk (%)	# Events	Affected / at Risk (%)	# Events
Total	0/41 (0%)		0/43 (0%)		0/53 (0%)		0/53 (0%)
Serious Adverse Events
	Glasses- Older Cohort		Observation- Older Cohort		Glasses- Younger Cohort		Observation- Younger Cohort
	Affected / at Risk (%)	# Events	Affected / at Risk (%)	# Events	Affected / at Risk (%)	# Events	Affected / at Risk (%)	# Events
Total	0/41 (0%)		0/43 (0%)		0/53 (0%)		0/53 (0%)
Other (Not Including Serious) Adverse Events
	Glasses- Older Cohort		Observation- Older Cohort		Glasses- Younger Cohort		Observation- Younger Cohort
	Affected / at Risk (%)	# Events	Affected / at Risk (%)	# Events	Affected / at Risk (%)	# Events	Affected / at Risk (%)	# Events
Total	0/41 (0%)		0/43 (0%)		0/53 (0%)		0/53 (0%)

Limitations/Caveats

[Not Specified]

More Information

Certain Agreements

Principal Investigators are NOT employed by the organization sponsoring the study.

There is NOT an agreement between Principal Investigators and the Sponsor (or its agents) that restricts the PI's rights to discuss or publish trial results after the trial is completed.