Methods, statistical features, and baseline results of a standardized, multicentered ophthalmologic surgical trial: the Silicone Study.
This article describes the trial design and baseline results for the Silicone Study, a multicenter, randomized surgical trial designed to compare the effectiveness of silicone fluid versus long-acting gas in the treatment of proliferative vitreoretinopathy (PVR). Design features include (1) standardization of the surgical protocol to reduce intersurgeon variability, (2) formulation of a PVR clinical classification system relevant to modern vitreoretinal surgery, and (3) creation of a photographic protocol to document PVR pathology. Statistical issues affecting the analysis of the outcome data include (1) the addition of a second group of patients with more severely diseased eyes after the trial began, (2) the change to a different long-acting gas during the course of the trial, and (3) recurrent retinal detachments that require reoperations with the randomized treatment, and, in some instances, a crossover from the randomized to the alternate treatment. Demographic and baseline ocular characteristics are presented for the two groups under study.
Duke Scholars
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DOI
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Related Subject Headings
- Vitreous Body
- Silicones
- Retinal Diseases
- Retinal Detachment
- Research Design
- Reoperation
- Public Health
- Postoperative Complications
- Photography
- Ophthalmology
Citation
Published In
DOI
ISSN
Publication Date
Volume
Issue
Start / End Page
Location
Related Subject Headings
- Vitreous Body
- Silicones
- Retinal Diseases
- Retinal Detachment
- Research Design
- Reoperation
- Public Health
- Postoperative Complications
- Photography
- Ophthalmology