Comparison of AmblyzTM Glasses and Patching for Amblyopia

Study Overview
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Brief Summary
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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.

Official Title
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Comparison of AmblyzTM Glasses and Patching for Amblyopia

Conditions
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Amblyopia

Intervention / Treatment
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* Device: 4-hour AmblyZ glasses
* Device: 12-hour AmblyZ glasses
* Device: 2-hour patching
* Device: 6-hour patching


Participation Criteria
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Eligibility Criteria
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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.

Ages Eligible for Study
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Minimum Age: 3 Years
Maximum Age: 8 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: 4-hour AmblyZ glasses<br>4-hour AmblyZ glasses for moderate amblyopia | Device: 4-hour AmblyZ glasses<br>* 4-hour AmblyZ glasses for moderate amblyopia<br>|
| Active Comparator: 2-hour eye patching<br>2-hour eye patching for moderate amblyopia | Device: 2-hour patching<br>* 2-hour patching for moderate amblyopia<br>|
| Experimental: 12-hour AmblyZ glasses<br>12-hour AmblyZ glasses for severe amblyopia | Device: 12-hour AmblyZ glasses<br>* 12-hour AmblyZ glasses for severe amblyopia<br>|
| Active Comparator: 6-hour eye patching<br>6-hour eye patching for severe amblyopia | Device: 6-hour patching<br>* 6-hour patching for severe amblyopia<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Visual Acuity Change During 12 Weeks | Visual acuity change during 12 weeks: the difference of visual acuity at baseline and 12 weeks. | 12 weeks | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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amblyopia