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

Publication ,  Journal Article
Azen, SP; Boone, DC; Barlow, W; McCuen, BW; Walonker, AF; Anderson, MM; Lean, JS; Mowery, RL; Ryan, SJ; Stern, W
Published in: Control Clin Trials
June 1991

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

Published In

Control Clin Trials

DOI

ISSN

0197-2456

Publication Date

June 1991

Volume

12

Issue

3

Start / End Page

438 / 455

Location

United States

Related Subject Headings

  • Vitreous Body
  • Silicones
  • Retinal Diseases
  • Retinal Detachment
  • Research Design
  • Reoperation
  • Public Health
  • Postoperative Complications
  • Photography
  • Ophthalmology
 

Citation

APA
Chicago
ICMJE
MLA
NLM
Azen, S. P., Boone, D. C., Barlow, W., McCuen, B. W., Walonker, A. F., Anderson, M. M., … Stern, W. (1991). Methods, statistical features, and baseline results of a standardized, multicentered ophthalmologic surgical trial: the Silicone Study. Control Clin Trials, 12(3), 438–455. https://doi.org/10.1016/0197-2456(91)90022-e
Azen, S. P., D. C. Boone, W. Barlow, B. W. McCuen, A. F. Walonker, M. M. Anderson, J. S. Lean, R. L. Mowery, S. J. Ryan, and W. Stern. “Methods, statistical features, and baseline results of a standardized, multicentered ophthalmologic surgical trial: the Silicone Study.Control Clin Trials 12, no. 3 (June 1991): 438–55. https://doi.org/10.1016/0197-2456(91)90022-e.
Azen SP, Boone DC, Barlow W, McCuen BW, Walonker AF, Anderson MM, et al. 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.
Azen, S. P., et al. “Methods, statistical features, and baseline results of a standardized, multicentered ophthalmologic surgical trial: the Silicone Study.Control Clin Trials, vol. 12, no. 3, June 1991, pp. 438–55. Pubmed, doi:10.1016/0197-2456(91)90022-e.
Azen SP, Boone DC, Barlow W, McCuen BW, Walonker AF, Anderson MM, Lean JS, Mowery RL, Ryan SJ, Stern W. Methods, statistical features, and baseline results of a standardized, multicentered ophthalmologic surgical trial: the Silicone Study. Control Clin Trials. 1991 Jun;12(3):438–455.
Journal cover image

Published In

Control Clin Trials

DOI

ISSN

0197-2456

Publication Date

June 1991

Volume

12

Issue

3

Start / End Page

438 / 455

Location

United States

Related Subject Headings

  • Vitreous Body
  • Silicones
  • Retinal Diseases
  • Retinal Detachment
  • Research Design
  • Reoperation
  • Public Health
  • Postoperative Complications
  • Photography
  • Ophthalmology