Comparison of AmblyzTM Glasses and Patching for Amblyopia
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 amblyopia as the standard 2-hour patching amblyopia treatment. This study is designed to evaluate the effectiveness of a novel amblyopia treatment, AmblyzTM glasses, in treating 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.
|Study Design:||Allocation: Randomized
Endpoint Classification: Efficacy Study
Intervention Model: Parallel Assignment
Masking: Open Label
Primary Purpose: Treatment
|Official Title:||Comparison of AmblyzTM Glasses and Patching for Amblyopia|
- Visual acuity [ Time Frame: 12 weeks ] [ Designated as safety issue: No ]Visual acuity will be assessed at baseline and 12 weeks.
|Study Start Date:||November 2013|
|Estimated Study Completion Date:||December 2016|
|Estimated Primary Completion Date:||December 2015 (Final data collection date for primary outcome measure)|
Experimental: AmblyZ glasses
4-hour AmblyZ glasses
|Device: AmblyZ glasses|
Active Comparator: eye patching
2-hour eye patching
|Device: eye patch|
Please refer to this study by its ClinicalTrials.gov identifier: NCT01973348
|United States, Indiana|
|Riley Hospital for Children||Recruiting|
|Indianapolis, Indiana, United States, 46202|
|Contact: Jingyun Wang, PhD 317-944-8103 email@example.com|