Clinical evaluation of the safety and efficacy of preservative-free triamcinolone (triesence® [triamcinolone acetonide injectable suspension] 40 MG/ML) for visualization during pars plana vitrectomy

David Dyer, David Callanan, Thomas Bochow, Prema Abraham, H. Michael Lambert, S. Young Lee, Todd Schneiderman, Susan L. Potts, Thomas M. Walker

Research output: Contribution to journalArticle

30 Scopus citations

Abstract

Purpose: To evaluate the safety and efficacy of preservative-free triamcinolone (TRIESENCE® suspension) for visualization during pars plana vitrectomy. METHODS:: This phase III, observer-masked study was conducted in 6 centers by 10 surgeons and enrolled 60 patients undergoing pars plana vitrectomy. Preservative-free triamcinolone (up to 4 mg) was administered to all patients to enhance visualization of vitreous and membranes. During each surgery, video recordings captured visualization pre- and postinstillation of preservative-free triamcinolone. An independent, masked reader evaluated the videos for the degree of visualization using a five-point scale ranging from 0 (not visible) to 4 (clearly delineated). Surgeons used a five-point scale ranging from "strongly disagree" to "strongly agree" to assess whether preservative-free triamcinolone improved visualization. RESULTS:: In 59 of 60 cases, the masked reader's scores for visualization of posterior segment structures were higher (i.e., structures were more clearly visible) after instillation of preservative-free triamcinolone. The preinstillation mean visualization score was 0.5 compared to 3.7 postinstillation (P < 0.0001). Greater than 90% of surgeon evaluations agreed or strongly agreed that preservative-free triamcinolone enhanced visualization of posterior segment structures. No safety issues were identified. CONCLUSIONS:: Preservative-free triamcinolone (TRIESENCE® suspension) was well tolerated and effectively enhanced visualization of posterior segment structures during pars plana vitrectomy.

Original languageEnglish (US)
Pages (from-to)38-45
Number of pages8
JournalRetina
Volume29
Issue number1
DOIs
StatePublished - Jan 2009

ASJC Scopus subject areas

  • Ophthalmology

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