Binocular Treatment of Amblyopia Before and After Strabismus Surgery
Completed · Not applicable · Has a placebo group
Conditions studied: Amblyopia, Strabismus
In brief
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 in one eye due to a present or former eye misalignment). Patients will be randomized to receive the study treatment either before or after strabismus surgery (i.e., corrective eye alignment surgery) or sham treatment before surgery. The study hypothesis is that there will be no significant change in vision in neither the pre nor post-surgery groups and no significant change in vision in neither the sham nor actual treatment groups.
Key facts
- Study ID
- NCT01791946
- Run by
- Massachusetts Eye and Ear Infirmary
- People needed
- 22
- Starts
- 2013-01-01
- Expected to finish
- 2016-09-01
- Last updated by the study team
- 2017-01-13
Who can join
Age: 18 and older, up to 60. Sex: any. Healthy volunteers: not accepted.
You may qualify if…
- 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.
You may not qualify if…
- 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.
Where it is running
- Massachusetts Eye and Ear Infirmary — Boston, Massachusetts, United States
Full record on ClinicalTrials.gov
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