A Randomized Trial to Evaluate Sequential vs Simultaneous Patching

Mean Change in Amblyopic Eye logMAR distance Visual Acuity

1. Amblyopic eye VA (calculated as mean of test and retest) at the last visit that was the basis for a "stable resolved" or "stable residual" determination (in the sequential group, stable residual amblyopia criteria can be reached only after patching has been instituted); or 2. 56-week visit amblyopic-eye VA (calculated as mean of test and retest) in those completing a 56-week visit without ever meeting criteria for "stable resolved" or "stable residual" amblyopia (if retest missing at 56 weeks, the single test value will be used).

Pediatric Eye Questionnaire (PedEyeQ)

Rasch scores for each questionnaire item will be obtained from published look-up tables available at www.pedig.net, and used to calculate a score for each participant and a separate treatment group mean for the three PedEyeQ domains of the Child, Proxy and Parent PedEyeQ at randomization and at each visit. Scores will also be converted to a 0-100 scale to aid in interpretation. Multiplicity adjusted two sided P-values and confidence intervals will be produced. Child PedEyeQ: Functional Vision, Bothered by Eyes and Vision, Social, Frustration / Worry Proxy PedEyeQ: Functional Vision, Bothered by Eyes and Vision, Social, Frustration / Worry, Eyecare Parent PedEyeQ: Impact on Parent and Family, Worry about Child's Eye Condition, Worry about Self-perception and Interactions, Worry about Functional Vision

Proportion Achieving Stable Resolved Outcome with Spectacles Alone

The proportion of participants in the Sequential Spectacles group who achieve "stable resolved" outcome status with spectacles alone will be calculated, along with a multiplicity adjusted two sided P-value and confidence interval.

Proportion of participants who achieve Binary distance visual acuity outcomes

The proportion of participants who achieve the following binary outcomes will be tabulated by treatment group to aid in the interpretation of the primary outcome: * The proportion of participants with outcome amblyopic-eye distance VA improvement of ≥ 2 logMAR lines (≥ 10 letters if E-ETDRS) from baseline. * The proportion of participants with stable resolved VA. Poisson regression with the log link will be used to estimate the relative risk of each outcome for the sequential versus simultaneous and a multiplicity adjusted two sided P-value and confidence interval. The Poisson models will include an adjustment for baseline amblyopic eye VA. In the event the number of outcomes is too small for reliable estimation with Poisson regression,43 a treatment group difference and 95% confidence interval will be estimated using the Farrington-Manning Score test or other exact method with no adjustment for baseline VA.

Time to Stable Resolved Amblyopia

For those participants who are classified as "stable resolved," the time from baseline to the time meeting that classification will be compared between treatment groups, using a Kaplan-Meier analysis with the logrank test. Multiplicity adjusted two sided P-values and confidence intervals will be produced.