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T. W. Bochow, D. Callanan, D. Dyer, P. Abraham, M. Lambert, S. Lee, T. Schneiderman; Clinical Evaluation of the Safety and Efficacy of TRIESENCETM (Triamcinolone Acetonide Injectable Suspension) 40 mg/mL for Visualization of Vitreous and Membranes in Pars Plana Vitrectomy. Invest. Ophthalmol. Vis. Sci. 2008;49(13):5601.
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To evaluate the safety and efficacy of preservative-free TRIESENCETM (triamcinolone acetonide injectable suspension) when used for visualization during pars plana vitrectomy with or without membrane removal.
This was a multi-center, observer-masked study of 60 patients undergoing pars plana vitrectomy. Patients received TRIESENCETM (triamcinolone acetonide injectable suspension) 40 mg/mL at doses of 1 - 4 mg (0.025 - 0.1 cc; as needed) as a surgical adjunct for enhancing visualization. Visualization, the primary efficacy endpoint, was assessed by an independent masked observer’s evaluation of videos taken before and after the addition of TRIESENCETM. Visualization of the relevant posterior segment structures was quantified using a 5-point scale anchored at the ends by ‘Not Visible (0)’ and ‘Clearly Delineated (4)’. The secondary efficacy endpoint was the surgeon’s assessment of the ability of TRIESENCETM to improved visualization. Safety variables included IOP assessment as well as assessment of posterior segment abnormalities.
In 59 of 60 cases, the masked observer scores for visualization of posterior segment structures during pars plana vitrectomy were higher (i.e., structures were more clearly visible) after injection of TRIESENCETM (3.2 unit mean improvement on the 5-unit visualization scale (p<0.0001). Additionally, over 90% of investigator evaluations either "Agreed" or "Strongly Agreed" that the use of TRIESENCETM enhanced visualization of posterior segment structures during pars plana vitrectomy surgeries. Based upon a review of adverse events, no untoward safety issues were identified in a population of adult and elderly patients exposed to TRIESENCETM during surgery and followed for 7 days postoperatively.
Preservative-free TRIESENCETM (triamcinolone acetonide injectable suspension) is safe and effective for enhancing visualization of posterior segment structures during pars plana vitrectomy with or without membrane removal.
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