Comparison of AmblyzTM Glasses and Patching for Amblyopia

Indiana University

Status: Terminated

Conditions: Amblyopia

Treatments: Device: 2-hour patching; Device: 12-hour AmblyZ glasses; Device: 6-hour patching; Device: 4-hour AmblyZ glasses

Study type: Interventional

Funder types: Other

Identifiers

NCT01973348

1307011930

Details and patient eligibility

About

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.

Enrollment: 45 patients

Sex: All

Ages: 3 to 8 years old

Volunteers: No Healthy Volunteers

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.

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: None (Open label)

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45 participants in 4 patient groups

4-hour AmblyZ glasses

Experimental group

Description:

4-hour AmblyZ glasses for moderate amblyopia

Treatment:

Device: 4-hour AmblyZ glasses

2-hour eye patching

Active Comparator group

Description:

2-hour eye patching for moderate amblyopia

Treatment:

Device: 2-hour patching

12-hour AmblyZ glasses

Experimental group

Description:

12-hour AmblyZ glasses for severe amblyopia

Treatment:

Device: 12-hour AmblyZ glasses

6-hour eye patching

Active Comparator group

Description:

6-hour eye patching for severe amblyopia

Treatment:

Device: 6-hour patching