Comparison of AmblyzTM Glasses and Patching for Amblyopia
| Status: | Recruiting |
|---|---|
| Conditions: | Ocular |
| Therapuetic Areas: | Ophthalmology |
| Healthy: | No |
| Age Range: | 3 - 8 |
| Updated: | 4/21/2016 |
| Start Date: | November 2013 |
| End Date: | December 2017 |
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.
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.
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.
We found this trial at
1
site
705 Riley Hospital Dr
Indianapolis, Indiana 46202
Indianapolis, Indiana 46202
(317) 944-5000
Phone: 317-944-8103
Riley Hospital for Children Riley Hospital for Children at IU Health is a place of...
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