Comparison of AmblyzTM Glasses and Patching for Amblyopia

Electronic eyeglasses, Amblyz™glasses, are a new medical device designed to treat amblyopia, which intermittently become opaque and provide effective occlusion for 50% of the time they are worn. A non-randomized study reported that Amblyz glasses yield an improvement in the amblyopic eye and offer an alternative effective treatment. We are unaware of any randomized clinical trial reports of response to AmblyzTM glasses treatment of amblyopia. Our hypothesis: Amblyz™glasses can improve visual acuity of the amblyopic eye as effective as traditional patching treatment. The primary objective is to determine if AmblyzTM equally treats moderate amblyopia as the standard 2-hour patching treatment and AmblyzTM equally treats severe amblyopia as the standard 6-hour patching treatment. This study is designed to evaluate the effectiveness of a novel amblyopia treatment, AmblyzTM glasses, in treating amblyopia. Moderate amblyopia: Children ages 3 to <8 years with visual acuity of 20/40 to 20/80 in the amblyopic eye will be enrolled and randomized into two groups: 4-hour AmblyzTM glasses treatment group and standard 2-hour patching control group. Severe amblyopia: Children ages 3 to <8 years with visual acuity of 20/100 to 20/400 in the amblyopic eye will be enrolled and randomized into two groups: 12-hour AmblyzTM glasses treatment group and standard 6-hour patching control group.

The significant ocular deviation is defined as equal or over 10 degrees of deviation more than that of the baseline.

Inclusion Criteria: Both genders and all races are eligible to this study. Age 3 to 8 years Amblyopia associated with strabismus, anisometropia, or both Visual acuity in the amblyopic eye between 20/40 and 20/80 inclusive Visual acuity in the sound eye 20/40 or better and inter-eye acuity difference >3 logarithm of the minimum angle of resolution (logMAR) lines Wearing of optimal spectacle correction for a minimum of 4 weeks at the time of enrollment. Exclusion Criteria: • No amblyopia treatment before enrollment.

Wang J, Neely DE, Galli J, Schliesser J, Graves A, Damarjian TG, Kovarik J, Bowsher J, Smith HA, Donaldson D, Haider KM, Roberts GJ, Sprunger DT, Plager DA. A pilot randomized clinical trial of intermittent occlusion therapy liquid crystal glasses versus traditional patching for treatment of moderate unilateral amblyopia. J AAPOS. 2016 Aug;20(4):326-31. doi: 10.1016/j.jaapos.2016.05.014. Epub 2016 Jul 12.