Comparison of AmblyzTM Glasses and Patching for Amblyopia

Study Results

Results available

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Basic Information

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Recruitment Status

TERMINATED

Clinical Phase

NA

Total Enrollment

45 participants

Study Classification

INTERVENTIONAL

Study Start Date

2013-11-30

Study Completion Date

2016-05-31

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.

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Detailed Description

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Conditions

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Amblyopia

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

TREATMENT

Blinding Strategy

NONE

Study Groups

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4-hour AmblyZ glasses

4-hour AmblyZ glasses for moderate amblyopia

Group Type EXPERIMENTAL

4-hour AmblyZ glasses

Intervention Type DEVICE

4-hour AmblyZ glasses for moderate amblyopia

2-hour eye patching

2-hour eye patching for moderate amblyopia

Group Type ACTIVE_COMPARATOR

2-hour patching

Intervention Type DEVICE

2-hour patching for moderate amblyopia

12-hour AmblyZ glasses

12-hour AmblyZ glasses for severe amblyopia

Group Type EXPERIMENTAL

12-hour AmblyZ glasses

Intervention Type DEVICE

12-hour AmblyZ glasses for severe amblyopia

6-hour eye patching

6-hour eye patching for severe amblyopia

Group Type ACTIVE_COMPARATOR

6-hour patching

Intervention Type DEVICE

6-hour patching for severe amblyopia

Interventions

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4-hour AmblyZ glasses

4-hour AmblyZ glasses for moderate amblyopia

Intervention Type DEVICE

12-hour AmblyZ glasses

12-hour AmblyZ glasses for severe amblyopia

Intervention Type DEVICE

2-hour patching

2-hour patching for moderate amblyopia

Intervention Type DEVICE

6-hour patching

6-hour patching for severe amblyopia

Intervention Type DEVICE

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.