Status:
COMPLETED
Binocular Treatment of Amblyopia Before and After Strabismus Surgery
Lead Sponsor:
Massachusetts Eye and Ear Infirmary
Conditions:
Amblyopia
Strabismus
Eligibility:
All Genders
18-60 years
Phase:
NA
Brief Summary
The primary objective of this study is to assess the effectiveness of an investigational binocular treatment in improving vision in strabismic amblyopes (i.e., patients with lazy eye, or poor vision i...
Detailed Description
This is a placebo-controlled, partially-randomized clinical trial. The patients will be assigned to one of two groups, Treatment Group A or Treatment B group. To help minimize bias, a blinded staff me...
Eligibility Criteria
Inclusion
- Presence of amblyopia in one eye due to congenital strabismus.
- Amblyopic eye has a fully-corrected visual acuity of 20/30 or less with no other cause for the visual loss except amblyopia.
- Patient is 18 to 60 years old.
- Corrected vision in other eye is normal.
- Eligible for strabismus surgery or has completed it previously with a successful outcome, as determined by the treating physician.
- Available and willing to comply with examination procedures and schedule.
- Signed and dated informed consent.
Exclusion
- Fully-corrected visual acuity of less than 20/30 in both eyes.
- Visual decrement due to anything other than amblyopia.
- At high risk for developing intractable diplopia (double vision) if vision in weak eye is improved. (To be determined by treating physician.)
- Unable or unavailable to complete at least 18 hours of binocular treatment over the course of six weeks.
- Currently enrolled in another research study.
Key Trial Info
Start Date :
January 1 2013
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
September 1 2016
Estimated Enrollment :
22 Patients enrolled
Trial Details
Trial ID
NCT01791946
Start Date
January 1 2013
End Date
September 1 2016
Last Update
January 13 2017
Active Locations (1)
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1
Massachusetts Eye and Ear Infirmary
Boston, Massachusetts, United States, 02114