Clinical Trial: Binocular Treatment of Amblyopia Before and After Strabismus Surgery

Study Status: Completed
Recruit Status: Completed
Study Type: Interventional

Official Title: Binocular Treatment of Amblyopia Before and After Strabismus Surgery

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 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.

Detailed Summary:

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 member will perform the visual acuity assessments throughout the study. The PI and Sub-I's will remain blinded to the treatment groups so that they may perform the visual exams throughout the study, if necessary.

Patients who have had strabismus surgery prior to being recruited will be allowed to participate in the study and, if eligible, will be automatically assigned to Treatment Group A.

Patients who are scheduled to have strabismus surgery at least six weeks from their screening clinic visit will be allowed to participate, once eligibility is determined. These patients will be included in Treatment Group B and randomized to either actual treatment or sham treatment. Each eligible participant will be included in the study and blinded as to which treatment group s/he has been assigned.

The duration of each subject's participation in the study will be about 7.5 months. All subjects will have a baseline visit to assess eligibility. Subjects in Treatment Group A will undergo strabismus surgery, if it was not previously performed, followed by 6 weeks of binocular treatment and a 3-6 month follow-up period. NOTE: There will be 4-6 weeks between surgery and the start of treatment to allow for full post-surgery recovery before starting treatment. Subjects in Treatment Group B will undergo 6 weeks of treatment/sham followed by strabismus surgery and a 3-6 month follow-up period.

If a treatment effect on vision is found, participants enrolled in the sham treatment arm will be offered the binocular treatment at the conclusion of the study
Sponsor: Massachusetts Eye and Ear Infirmary

Current Primary Outcome: The primary outcome variable is a composite of the difference in visual acuity and stereo vision measurements taken before binocular treatment and strabismus surgery versus after binocular treatment and strabismus surgery. [ Time Frame: This is a change outcome measure. That is measurements will be taken at baseline, 6 weeks, and approximately 3 months. ]

Original Primary Outcome: The primary outcome variable is a composite of the difference in visual acuity and stereo vision measurements taken before binocular treatment and strabismus surgery versus after binocular treatment and strabismus surgery. [ Time Frame: This is a change outcome measure. That is measurements will be taken at baseline, 7 weeks, and 3 months. ]

Current Secondary Outcome:

Original Secondary Outcome:

Information By: Massachusetts Eye and Ear Infirmary

Dates:
Date Received: February 7, 2013
Date Started: January 2013
Date Completion:
Last Updated: January 12, 2017
Last Verified: October 2015