A multicenter, prospective, randomized clinical trial to evaluate the relative merits of intravitreal injection of silicone oil or 20% SF-6/air mixture gas after vitrectomy in the treatment of complicated retinal detachment, i.e., proliferative vitreoretinopathy (PVR) is proposed. This document pertains only to the Coordinating Center for the study. The eleven Contributing Centers will all be self supporting. Each Contributing Center will provide to the Coordinating Center approximately 16 cases of PVR over 18 months of recruitment (total sample size = 176). Patients will be randomized to silicone oil or gas during the surgery. Follow-up is for two years post-operation. To evaluate the efficacy of the treatments, the rates of anatomical reattachment of the macula at six months post-operation (primary endpoint) will be compared between the two treatment groups. Additionally, the best corrected visual acuity (secondary endpoint), visual field improvement and complications will be monitored, compared, and reported. It is expected that the macular attachment rate for patients treated with silicone will be 1-1/2 times greater than that for patients treated with gas (power of the trial = 0.80).

Agency
National Institute of Health (NIH)
Institute
National Eye Institute (NEI)
Type
Cooperative Clinical Research--Cooperative Agreements (U10)
Project #
5U10EY005571-07
Application #
3559136
Study Section
Vision Research and Training Committee (VSN)
Project Start
1985-01-04
Project End
1992-12-31
Budget Start
1991-01-01
Budget End
1991-12-31
Support Year
7
Fiscal Year
1991
Total Cost
Indirect Cost
Name
University of Southern California
Department
Type
Schools of Medicine
DUNS #
041544081
City
Los Angeles
State
CA
Country
United States
Zip Code
90089