Comparison of AmblyzTM Glasses and Patching for Amblyopia

Amblyopia Clinical Trial

Official title:

Comparison of AmblyzTM Glasses and Patching for Amblyopia

Clinical Trial Details — Status: Terminated

Administrative data

• NCT number: NCT01973348
• Other study ID #: 1307011930
• Status: Terminated
• Phase: N/A
• First received: October 25, 2013
• Last updated: July 20, 2017
• Start date: November 2013
• Est. completion date: May 2016

Study information

• Verified date: July 2017
• Source: Indiana University
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

Recruitment information / eligibility

• Status: Terminated
• Enrollment: 45
• Est. completion date: May 2016
• Est. primary completion date: May 2016
• Accepts healthy volunteers: No
• Gender: All
• Age group: 3 Years to 8 Years

Eligibility

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.

Related Conditions & MeSH terms

• Amblyopia

Intervention

Device:
• 4-hour AmblyZ glasses
4-hour AmblyZ glasses for moderate amblyopia
• 12-hour AmblyZ glasses
12-hour AmblyZ glasses for severe amblyopia
• 2-hour patching
2-hour patching for moderate amblyopia
• 6-hour patching
6-hour patching for severe amblyopia

Locations

Country	Name	City	State
United States	Riley Hospital for Children	Indianapolis	Indiana

Sponsors (1)

Lead Sponsor	Collaborator
Indiana University

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Other	Reverse Amblyopia	it is defined that the strong eye of the patient decreases two logMAR lines over 3 months.	3 Months
Other	Significant Ocular Deviation Increase From the Baseline	The significant ocular deviation is defined as equal or over 10 degrees of deviation more than that of the baseline.	3 Months
Primary	Visual Acuity Change	Visual acuity change will be assessed by calculating the difference of visual acuity at baseline and 12 weeks.	12 weeks