CLINICAL EVALUATION OF THE SAFETY AND EFFICACY OF PRESERVATIVE-FREE TRIAMCINOLONE (TRIESENCE (R) [TRIAMCINOLONE ACETONIDE INJECTABLE SUSPENSION] 40 MG/ML) FOR VISUALIZATION DURING PARS PLANA VITRECTOMY

Purpose: To evaluate the safety and efficacy of preservative-free triamcinolone (TRIESENCE (R) 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 (R) suspension) was well tolerated and effectively enhanced visualization of posterior segment structures during pars plana vitrectomy.