Study Objectives To compare the efficacy and safety of surgical treatment (PRK) versus non-surgical treatment of anisometropic amblyopia in children who have failed conventional treatment due to non-compliance or non-response. Synopsis of Study Design The study consists of two phases: 1. A Patching Run-In Phase during which all participants are treated for at least 8 weeks with continued refractive correction (with spectacles and/or contact lenses) and patching prescribed 42 hours per week (averaging 6 hours daily) until no further improvement over 2 consecutive visits at least 4 weeks apart or the vision no longer meets eligibility criteria. 2. A Randomized Trial Phase, beginning after no further VA improvement in the patching run-in phase and qualifying amblyopia is still present, during which the participant is assigned to either surgery with PRK and patching prescribed 2 hours per day or to non-surgical treatment with continued refractive correction (with spectacles and/or contact lenses) and patching prescribed 2 hours per day.
The study is evaluating the efficacy of surgical treatment with PRK versus non-surgical treatment of anisometropic amblyopia in children who have failed conventional treatment. The primary analysis will be a treatment group comparison of the change in BCVA in the amblyopic eye at the 8-month primary outcome visit. For participants wearing a contact lens, the BCVA will be the visual acuity tested in the contact lens rather than in spectacles (or trial frames).
Study Type
INTERVENTIONAL
Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
SINGLE
Subjects randomized to refractive surgery will be referred to one of six study surgical centers (surgical centers are listed in Appendix B) to have photorefractive keratectomy (PRK) in the affected eye within 60 days after randomization.
Patching prescribed 2 hours per day with continued refractive correction (with spectacles and/or contact lenses) as able.
Excimer Laser System for use in photorefractive keratectomy.
Mean Change in Best Corrected Visual Acuity in the Amblyopic Eye
Treatment group comparison of the change in Best-Corrected ATS-HOTV VA (BCVA) in the amblyopic eye at 8 months after randomization. ATS-HOTV = ATS single-surround HOTV testing protocol
Time frame: from randomization to the 8-month primary outcome visit
Randot Preschool Stereoacuity Outcomes by Treatment Group
The distribution of Randot Preschool stereoacuity at randomization and the 8-month primary outcome visit will be tabulated separately for each treatment group. Change in stereoacuity from randomization to the 8-month visit will be tabulated for each group and compared between treatment groups using the exact Wilcoxon rank-sum test.
Time frame: At 8 months after randomization
Refractive Error Outcomes in Surgery Group
The distribution of change in refractive error in each eye at 7 months after randomization will be tabulated with computation of descriptive statistics. The difference between the 7-month refractive error and the target refractive error will be tabulated with computation of descriptive statistics.
Time frame: At 7 months after randomization
Visual Acuity Outcomes
A point estimate and corresponding 95% confidence interval will be calculated for the mean change in BCVA for the amblyopic-eye 8 months after baseline, adjusted for minimization covariates of age and VA at baseline as well as anisometropia type (hyperopia, myopia). The analyses will include data completed within the pre-specified analysis window for the 8-month visit after baseline and will follow a modified intent-to-treat principle as outlined for the primary analysis.
Time frame: At 8 months
Distribution of refractive error outcomes
The distribution of refractive error outcomes at 7 months after baseline will be tabulated with computation of descriptive statistics.
Time frame: At 7 months after baseline
Distribution in Randot Preschool stereoacuity level
The distribution in Randot Preschool stereoacuity level at baseline and 8 months after baseline and the change in stereoacuity for this interval will be tabulated and compared using a Wilcoxon signed rank test.
Time frame: at baseline and 8 months
Visual Acuity Outcomes at 12 and 24 Months Post-surgery
The distribution of the level and change in BCVA in the amblyopic eye at 12 and 24 months after surgery will be tabulated by treatment group with computation of descriptive statistics.
Time frame: at 12 and 24 months after surgery
Stereoacuity at 12 and 24 Months Post-surgery
The distribution of Randot Preschool stereoacuity and change in stereoacuity at the 12- and 24-month post-surgery visits will be tabulated separately for each treatment group
Time frame: at 12 and 24 months after surgery
Refractive Error at 12 and 24 Months Post-surgery
The distribution of change in refractive error in each eye at 12 and 24 months after surgery will be tabulated by treatment group with computation of descriptive statistics. The difference between the refractive errors at these visits and the target refractive error will be tabulated by treatment group with computation of descriptive statistics.
Time frame: at 12 and 24 months after surgery
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