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

Control Clin Trials. 1991 Jun;12(3):438-55. doi: 10.1016/0197-2456(91)90022-e.

Abstract

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.

Publication types

  • Clinical Trial
  • Multicenter Study
  • Randomized Controlled Trial
  • Research Support, Non-U.S. Gov't
  • Research Support, U.S. Gov't, P.H.S.

MeSH terms

  • Adult
  • Aged
  • Aged, 80 and over
  • Certification
  • Documentation
  • Eye Diseases / therapy
  • Female
  • Gases / therapeutic use
  • Humans
  • Male
  • Middle Aged
  • Ophthalmology / methods*
  • Ophthalmology / standards
  • Photography
  • Postoperative Complications
  • Reoperation
  • Research Design
  • Retinal Detachment / etiology
  • Retinal Detachment / therapy*
  • Retinal Diseases / therapy
  • Silicones / therapeutic use
  • Vitreous Body

Substances

  • Gases
  • Silicones