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- W1999898983 abstract "In Brief 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. Preservative-free triamcinolone (TRIESENCE® suspension) (Alcon Laboratories, Inc.) is a newly Food and Drug Administration approved, preservative-free, terminally sterilized triamcinolone acetonide suspension specifically indicated for visualization during vitrectomy. Results from this study show that preservative-free triamcinolone (TRIESENCE® suspension) is safe and effective for enhancing visualization of posterior segment structures during pars plana vitrectomy." @default.
- W1999898983 created "2016-06-24" @default.
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- W1999898983 date "2009-01-01" @default.
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- W1999898983 title "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" @default.
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- W1999898983 doi "https://doi.org/10.1097/iae.0b013e318188c6e2" @default.
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