Methods, statistical features, and baseline results of a standardized, multicentered ophthalmologic surgical trial: the Silicone Study.

Journal Article (Clinical Trial;Journal Article;Multicenter 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.

Full Text

Duke Authors

Cited Authors

  • Azen, SP; Boone, DC; Barlow, W; McCuen, BW; Walonker, AF; Anderson, MM; Lean, JS; Mowery, RL; Ryan, SJ; Stern, W

Published Date

  • June 1991

Published In

Volume / Issue

  • 12 / 3

Start / End Page

  • 438 - 455

PubMed ID

  • 1651213

International Standard Serial Number (ISSN)

  • 0197-2456

Digital Object Identifier (DOI)

  • 10.1016/0197-2456(91)90022-e


  • eng

Conference Location

  • United States