Comparison of AmblyzTM Glasses and Patching for Amblyopia

Not Applicable

Terminated

• Conditions: Amblyopia
• Interventions: Device: 4-hour AmblyZ glasses; Device: 2-hour patching; Device: 12-hour AmblyZ glasses; Device: 6-hour patching

• Registration Number: NCT01973348
• Lead Sponsor: Indiana University

Brief Summary

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.

Detailed Description

Not available

Study Timeline

• Study First Submitted: 2013-10-25
• Study First Submitted QC: 2013-10-25
• Study First Posted: 2013-10-31
• Study Start: 2013-11
• Primary Completion: 2016-05
• Study Completion: 2016-05
• Results First Submitted: 2017-04-25
• Status Verified: 2017-07
• Results First Submitted QC: 2017-07-20
• Results First Posted: 2017-07-24
• Last Update Submitted: 2017-07-25
• Last Update Posted: 2017-08-25

Recruitment & Eligibility

• Status: TERMINATED
• Sex: All
• Target Recruitment: 45

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.

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
4-hour AmblyZ glasses	4-hour AmblyZ glasses	4-hour AmblyZ glasses for moderate amblyopia
2-hour eye patching	2-hour patching	2-hour eye patching for moderate amblyopia
12-hour AmblyZ glasses	12-hour AmblyZ glasses	12-hour AmblyZ glasses for severe amblyopia
6-hour eye patching	6-hour patching	6-hour eye patching for severe amblyopia

Primary Outcome Measures

Name	Time	Method
Visual Acuity Change During 12 Weeks	12 weeks	Visual acuity change during 12 weeks: the difference of visual acuity at baseline and 12 weeks.

Trial Locations

Locations (1)

Riley Hospital for Children; 🇺🇸 Indianapolis, Indiana, United States