funding and personnel are lack.

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.

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.

3 months

In addition to monitoring all Serious and non-serious adverse events, participants were specifically monitored/assessed for the following two major Other adverse events:

1. reverse amblyopia (the fellow good eye becomes two logMAR line worse than the amblyopic eye)
2. Significant deviation increase than baseline.

1. Sample size is limited; some patients did not come for followup visit.
2. Compliance with treatment is only estimated with calendar log and many patients did not bring back report.