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| ID | Type | Description | Link |
|---|---|---|---|
| 2U10EY011751 | U.S. NIH Grant/Contract | View source |
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| Name | Class |
|---|---|
| Pediatric Eye Disease Investigator Group | NETWORK |
| National Eye Institute (NEI) | NIH |
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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.
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.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Glasses | Active Comparator | Glasses are prescribed at enrollment and worn per protocol throughout the duration of the study. |
|
| Observation | Placebo Comparator | Glasses will not be prescribed unless the patient has confirmation of one or more deterioration criteria as described in the protocol. |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Glasses | Procedure | Glasses will be prescribed at enrollment with the sphere cut symmetrically by 1.00D and full cylinder correction. |
|
| Measure | Description | Time Frame |
|---|---|---|
| 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
| 36 months after randomization |
| Measure | Description | Time Frame |
|---|---|---|
| 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. | 36 months after randomization |
| Subgroup Analysis - Gender |
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Inclusion Criteria:
Age 12 to < 72 months
Refractive error between +3.00D and +6.00D SE (by cycloplegic refraction) in either eye
Astigmatism < 1.50D in both eyes
Spherical equivalent anisometropia ≤ +1.50D
For children 36 to <72 months of age:
Gestational age >32 weeks
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.
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.
Parent has phone (or access to phone) and is willing to be contacted by Jaeb Center staff.
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:
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| Name | Affiliation | Role |
|---|---|---|
| Marjean Kulp, OD, MS | Jaeb Center for Health Research | Study Chair |
| David Petersen, MD | Jaeb Center for Health Research | Study Chair |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| The Ohio State University College of Optometry | Columbus | Ohio | 43210-1280 | United States | ||
| Rocky Mountain Eye Care Associates |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 27663627 | Background | 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. | |
| 30615896 | Result | Pediatric Eye Disease Investigator Group; Kulp MT, Holmes JM, Dean TW, Suh DW, Kraker RT, Wallace DK, Petersen DB, Cotter SA, Manny RE, Superstein R, Roberts TL, Avallone JM, Fishman DR, Erzurum SA, Leske DA, Christoff A. A Randomized Clinical Trial of Immediate versus Delayed Glasses for Moderate Hyperopia in 1- and 2-Year-Olds. Ophthalmology. 2019 Jun;126(6):876-887. doi: 10.1016/j.ophtha.2018.12.049. Epub 2019 Jan 4. |
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In accordance with the NIH data sharing policy, a de-identified database is placed in the public domain on the PEDIG public website after the completion of each protocol and publication of the primary manuscript.
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Data will be made available after publication of each primary manuscript.
Users accessing the data must enter an email address.
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| ID | Title | Description |
|---|---|---|
| FG000 | 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. |
| FG001 | 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. |
| FG002 | 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. |
| FG003 | 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. |
| Title | Milestones | Reasons Not Completed | ||||||||||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Overall Study |
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| ID | Title | Description |
|---|---|---|
| BG000 | 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. |
| Units | Counts |
|---|---|
| Participants |
|
| Title | Description | Population Description | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Denominator Units Selected | Denominators | Classes |
|---|---|---|---|---|---|---|---|---|---|
| Age, Categorical | Count of Participants |
| Type | Title | Description | Population Description | Reporting Status | Anticipated Posting Date | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Time Frame | Units Analyzed | Denominator Units Selected | Arm/Group Information | Denominators | Classes | Analyses |
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| 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
| Overall number is the number of patients who completed the entire study. | Posted | Count of Participants | Participants | 36 months after randomization |
3 Years (36 months)
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| ID | Title | Description | Deaths (Affected) | Deaths (At Risk) | Serious Events (Affected) | Serious Events (At Risk) | Other Events (Affected) | Other Events (At Risk) |
|---|---|---|---|---|---|---|---|---|
| EG000 | 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. |
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| Title | Organization | Phone | Extension | |
|---|---|---|---|---|
| Ray Kraker M.S.P.H. | Jaeb Center for Health Research | 813-975-8690 | rkraker@jaeb.org |
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| Type | Includes Protocol | Includes SAP | Includes ICF | Document Label | Document Date | Document Uploaded Date | Document File Name |
|---|---|---|---|---|---|---|---|
| ICF | No | No | Yes | Informed Consent Form | Oct 14, 2013 | Mar 12, 2019 | ICF_000.pdf |
| SAP | No | Yes | No | Statistical Analysis Plan | Jul 25, 2018 | Mar 12, 2019 | SAP_001.pdf |
| Prot | Yes | No | No | Study Protocol | Jan 28, 2015 | Mar 12, 2019 | Prot_002.pdf |
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| ID | Term |
|---|---|
| D006956 | Hyperopia |
| ID | Term |
|---|---|
| D012030 | Refractive Errors |
| D005128 | Eye Diseases |
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| ID | Term |
|---|---|
| D005139 | Eyeglasses |
| ID | Term |
|---|---|
| D007909 | Lenses |
| D055096 | Optical Devices |
| D004864 | Equipment and Supplies |
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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. |
| 36 months |
| 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. | 36 months |
| 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. | 36 months |
| 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. | 36 months |
| 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. | 36 months |
| 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. | Enrollment to <36 months |
| 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. | Enrollment to 3 years |
| Percentage of Participants With Hyperopia Reduction | Percentage of Participants (%) in which hyperopia reduced by 1.00D (diopters) or more over 3 years | Enrollment to 3 years |
| 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. | 36 months after randomization |
| 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. | 36 months |
| 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) | 36 months after randomization |
| 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. | 36 months after randomization |
| 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. | 36 months after randomization |
| 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) | 36 months |
| 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. | 36 months |
| Salt Lake City |
| Utah |
| 84107 |
| United States |
| 31255587 | Result | Holmes JM, Kulp MT, Dean TW, Suh DW, Kraker RT, Wallace DK, Petersen DB, Cotter SA, Crouch ER, Lorenzana IJ, Ticho BH, Verderber LC, Weise KK; Pediatric Eye Disease Investigator Group. A Randomized Clinical Trial of Immediate Versus Delayed Glasses for Moderate Hyperopia in Children 3 to 5 Years of Age. Am J Ophthalmol. 2019 Dec;208:145-159. doi: 10.1016/j.ajo.2019.06.021. Epub 2019 Jun 28. |
| BG001 | 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. |
| BG002 | 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. |
| BG003 | 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. |
| BG004 | Total | Total of all reporting groups |
| Participants |
|
| Age, Customized | Count of Participants | Participants |
|
| Sex: Female, Male | Count of Participants | Participants |
|
| Race/Ethnicity, Customized | Count of Participants | Participants |
|
| Family History of Amblyopia | Family history of amblyopia was not available for 2 (3%) participants in glasses group and 3 (5%) in observation group in the Older Cohort. Family history of amblyopia was not reported for 3 participants (5%) in glasses group and 2 participants (3%) in observation group in the Younger Cohort. | Count of Participants | Participants |
|
| Family History of Strabismus | Family history of strabismus was not available for 2 (3%) participants in glasses group and 1 (2%) in the observation group in the Older Cohort. Family history of strabismus was not reported for 2 participants (3%) in glasses group in the Younger Cohort. | Count of Participants | Participants |
|
| Diagnosis Of ADHD | ADHD: Attention-Deficit/Hyperactivity Disorder | Count of Participants | Participants |
|
| SE Refractive Error: More hyperopic eye | 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. This measurement is in the more hyperopic eye, or the eye that sees worse at near than the other eye. | Count of Participants | Participants |
|
| SE Refractive Error: More hyperopic eye | 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. This measurement is in the more hyperopic eye, or the eye that sees worse at near than the other eye. | Mean | Standard Deviation | diopters (D) |
|
| SE Refractive Error: Less hyperopic eye | 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. This measurement is in the less hyperopic eye, or the eye that sees better at near than the other eye. | Count of Participants | Participants |
|
| SE Refractive Error: Less hyperopic eye | 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. This measurement is in the less hyperopic eye, or the eye that sees better at near than the other eye. | Mean | Standard Deviation | diopters (D) |
|
| Anisometropia | Anisometropia is when the refractive error between two eyes is different. The difference in spherical equivalent refraction between the eyes is measured in diopters (D). | Count of Participants | Participants |
|
| Anisometropia | Anisometropia is when the refractive error between two eyes is different. The difference in spherical equivalent refraction between the eyes is measured in diopters (D). | Mean | Standard Deviation | diopters (D) |
|
| Astigmatism: More astigmatic eye | Astigmatism is a condition in which the cornea or lens is irregular shaped/curved. The degree of astigmatism is measured in diopters (D). This measurement is in the more astigmatic eye, or the eye with a larger degree of astigmatism. | Count of Participants | Participants |
|
| Astigmatism: More astigmatic eye | Astigmatism is a condition in which the cornea or lens is irregular shaped/curved. The degree of astigmatism is measured in diopters (D). This measurement is in the more astigmatic eye, or the eye with a larger degree of astigmatism. | Mean | Standard Deviation | diopters (D) |
|
| Astigmatism: Less astigmatic eye | Astigmatism is a condition in which the cornea or lens is irregular shaped/curved. The degree of astigmatism is measured in diopters (D). This measurement is in the less astigmatic eye, or the eye with a smaller degree of astigmatism. | Count of Participants | Participants |
|
| Astigmatism: Less astigmatic eye | Astigmatism is a condition in which the cornea or lens is irregular shaped/curved. The degree of astigmatism is measured in diopters (D). This measurement is in the less astigmatic eye, or the eye with a smaller degree of astigmatism. | Mean | Standard Deviation | diopters (D) |
|
| Distance Visual Acuity: Better-seeing Eye | Distance visual acuity is typically measured by testing the smallest letter or object a patient can identify from 20 feet away. This measurement is recorded as a fraction. The numerator is the distance at which the patient is identifying the letter/object, while the denominator is the distance that a person with normal vision could identify that same object. For example, 20/20 vision is considered normal, where a patient can see at 20 feet what is normally seen at 20 feet. This measurement is for the better-seeing eye, or the eye with better visual acuity. | This measure was only used as a baseline characteristic for the Older cohort, no data for this characteristic was collected from the younger cohort. | Count of Participants | Participants |
|
| Distance Visual Acuity: Better-seeing Eye | Each visual acuity (VA) measure was assigned a logarithm of minimum angle of resolution (logMAR) equivalent, with 20/20 VA equal to 0 logMAR, and each progressively worse VA equal to an additional 0.1 logMAR. For example: 20/50 = 0.4 logMAR, 20/40 = 0.3 logMAR, 20/32 = 0.2 logMAR, 20/25 = 0.1 logMAR, 20/20 = 0 logMAR, 20/16 = -0.1 logMAR Larger logMAR indicates worse visual acuity. This measurement is for the better-seeing eye, or the eye with smaller logMAR visual acuity. | This measure was only used as a baseline characteristic for the Older cohort, no data for this characteristic was collected from the younger cohort. | Mean | Standard Deviation | logMAR |
|
| Distance Visual Acuity: Worse-seeing Eye | Distance visual acuity is typically measured by testing the smallest letter or object a patient can identify from 20 feet away. This measurement is recorded as a fraction. The numerator is the distance at which the patient is identifying the letter/object, while the denominator is the distance that a person with normal vision could identify that same object. For example, 20/20 vision is considered normal, where a patient can see at 20 feet what is normally seen at 20 feet. This measurement is for the worse-seeing eye, or the eye with worse visual acuity. | This measure was only used as a baseline characteristic for the Older cohort, no data for this characteristic was collected from the younger cohort. | Count of Participants | Participants |
|
| Distance Visual Acuity: Worse-seeing Eye | Each visual acuity (VA) measure was assigned a logarithm of minimum angle of resolution (logMAR) equivalent, with 20/20 VA equal to 0 logMAR, and each progressively worse VA equal to an additional 0.1 logMAR. For example: 20/50 = 0.4 logMAR, 20/40 = 0.3 logMAR, 20/32 = 0.2 logMAR, 20/25 = 0.1 logMAR, 20/20 = 0 logMAR, 20/16 = -0.1 logMAR Larger logMAR indicates worse visual acuity. This measurement is for the worse-seeing eye, or the eye with larger logMAR. | This measure was only used as a baseline characteristic for the Older cohort, no data for this characteristic was collected from the younger cohort. | Mean | Standard Deviation | logMAR |
|
| Stereoacuity at Near | 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. | This measure was only used as a baseline characteristic for the Older cohort, no data for this characteristic was collected from the younger cohort. | Count of Participants | Participants |
|
| Stereoacuity at Near | Measure Description: 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. | This measure was only used as a baseline characteristic for the Older cohort, no data for this characteristic was collected from the younger cohort. | Median | Full Range | seconds of arc (arcsec) |
|
| ID |
|---|
| Title |
|---|
| Description |
|---|
| OG000 | 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. |
| OG001 | 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. |
| OG002 | 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. |
| OG003 | 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. |
|
|
|
| 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. | Total number that experienced failure, as reported in primary outcome | Posted | Count of Participants | Participants | 36 months after randomization |
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| 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. | Total number that experienced failure, as reported in primary outcome | Posted | Count of Participants | Participants | 36 months |
|
|
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| 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. | Total number that experienced failure, as reported in primary outcome | Posted | Count of Participants | Participants | 36 months |
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| 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. | Total number that experienced failure, as reported in primary outcome | Posted | Count of Participants | Participants | 36 months |
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| 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. | Total number that experienced failure, as reported in primary outcome | Posted | Count of Participants | Participants | 36 months |
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| 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. | Total number that experienced failure, as reported in primary outcome | Posted | Count of Participants | Participants | 36 months |
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| 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. | Posted | Count of Participants | Participants | Enrollment to <36 months |
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| 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. | Overall number is the total number of patients who completed the 3-year study. | Posted | Mean | 95% Confidence Interval | diopters | Enrollment to 3 years |
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| Secondary | Percentage of Participants With Hyperopia Reduction | Percentage of Participants (%) in which hyperopia reduced by 1.00D (diopters) or more over 3 years | 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. | Posted | Number | percentage of participants | Enrollment to 3 years |
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| 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. | Posted | Mean | Standard Deviation | logMAR | 36 months after randomization |
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| 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. | Overall number is the total number of patients who completed the 3-year study. | Posted | Count of Participants | Participants | 36 months |
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| 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) | Overall number is the total number of patients who completed the 3-year study. | Posted | Count of Participants | Participants | 36 months after randomization |
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| 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. | Overall number is the total number of patients who completed the 3-year study. | Posted | Mean | Standard Deviation | logMAR | 36 months after randomization |
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| 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. | 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. | Posted | Count of Participants | Participants | 36 months after randomization |
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| 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) | Overall number is the total number of patients who completed the 3-year study. | Posted | Mean | Standard Deviation | logarithm of seconds of arc (log arcsec) | 36 months |
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| 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. | Overall number is the total number of patients who completed the 3-year study. | Posted | Count of Participants | Participants | 36 months |
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| 0 |
| 41 |
| 0 |
| 41 |
| 0 |
| 41 |
| EG001 | 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. | 0 | 43 | 0 | 43 | 0 | 43 |
| EG002 | 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. | 0 | 53 | 0 | 53 | 0 | 53 |
| EG003 | 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. | 0 | 53 | 0 | 53 | 0 | 53 |
Not provided
Not provided
| Between 18 and 65 years |
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| >=65 years |
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| Male |
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| Race - White |
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| Gender - Male |
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| Family History of Amblyopia- No |
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| Family History of Strabismus- No |
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| +0.50D to <+1.00D |
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| +1.00D to +1.50D |
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| +4.00D to <+5.00D |
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| +5.00D to +6.00D |
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| Less Hyperopic Eye |
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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. |
| ANCOVA |
| 0.002 |
Results are considered statistically significant if p<0.01. |
| Mean Difference (Final Values) |
| 0.58 |
| 2-Sided |
| 99 |
| 0.10 |
| 1.06 |
| Other |
| 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. | ANCOVA | 0.53 | Results are considered statistically significant if p≤0.01. | Mean Difference (Final Values) | 0.16 | 2-Sided | 99 | -0.51 | 0.84 | Other |
| 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. | ANCOVA | 0.38 | Results are considered statistically significant if p≤0.01. | Mean Difference (Final Values) | 0.22 | 2-Sided | 99 | -0.43 | 0.86 | Other |
Analysis for the less hyperopic eye: Barnard's exact test was used to compare proportions between treatment groups. |
| Barnard's Exact Test |
| 0.08 |
Results are considered statistically significant if p<0.01. |
| Hazard Ratio, log |
| -18 |
| 2-Sided |
| 99 |
| -42 |
| 8 |
| Other |
| Worse-seeing Eye |
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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. |
| ANCOVA |
| 0.41 |
| Mean Difference (Final Values) |
| -0.02 |
| 2-Sided |
| 99 |
| -0.06 |
| 0.03 |
| Other |
| 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. | ANCOVA | 0.02 | Mean Difference (Final Values) | -0.05 | 2-Sided | 99 | -0.12 | 0.01 | Other |
| 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. | ANCOVA | 0.15 | Mean Difference (Final Values) | -0.07 | 2-Sided | 99 | -0.19 | 0.05 | Other |
Barnard's exact test was used to compare proportions between treatment groups.
| Barnard's Exact Test |
| 0.79 |
Results are considered statistically significant if p<0.01. |
| Mean Difference (Final Values) |
| -2 |
| 2-Sided |
| 99 |
| -18 |
| 14 |
| Other |
Barnard's exact test was used to compare proportions between treatment groups.
| Barnard's Exact Test |
| 0.68 |
Results are considered statistically significant if p≤0.01. |
| Mean Difference (Final Values) |
| -4 |
| 2-Sided |
| 99 |
| -24 |
| 16 |
| Other |
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. |
| ANCOVA |
| 0.25 |
Results are considered statistically significant if p≤0.01. |
| Mean Difference (Final Values) |
| -0.03 |
| 2-Sided |
| 99 |
| -0.10 |
| 0.04 |
| Other |
Barnard's exact test used to compare proportions between treatment groups.
No p-value, because there was 0% difference |
| Mean Difference (Final Values) |
| 0 |
| 2-Sided |
| 99 |
| -17 |
| 17 |
| Other |
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. |
| ANCOVA |
| 0.15 |
| Mean Difference (Final Values) |
| -0.1 |
| 2-Sided |
| 99 |
| -0.4 |
| 0.1 |
| Other |
Barnard's exact test used to compare proportions between treatment groups.
| Barnard's Exact Test |
| 0.02 |
Results are considered statistically significant if p<0.01. |
| Mean Difference (Final Values) |
| -19 |
| 2-Sided |
| 99 |
| -40 |
| 2 |
| Other |