NCT01973348

Comparison of AmblyzTM Glasses and Patching for Amblyopia

• Status: Terminated
• Phase: N/A
• Study type: Interventional
• Enrollment: 45 (actual)
• Sponsor: Indiana University · Academic / Other
• Sex: All
• Age: 3 Years – 8 Years
• Healthy volunteers: Not accepted

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.

Conditions

• Amblyopia

Interventions

Type	Name	Description
DEVICE	4-hour AmblyZ glasses	4-hour AmblyZ glasses for moderate amblyopia
DEVICE	12-hour AmblyZ glasses	12-hour AmblyZ glasses for severe amblyopia
DEVICE	2-hour patching	2-hour patching for moderate amblyopia
DEVICE	6-hour patching	6-hour patching for severe amblyopia

Timeline

• Start date: 2013-11-01
• Primary completion: 2016-05-01
• Completion: 2016-05-01
• First posted: 2013-10-31
• Last updated: 2017-08-25
• Results posted: 2017-07-24

Locations

1 site across 1 country: United States