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One-year results of a multicenter controlled clinical trial of triamcinolone in pars plana vitrectomy.

Author(s): Yamakiri K, Sakamoto T, Noda Y, Nakahara M, Ogino N, Kubota T, Yokoyama M, Furukawa M, Ishibashi T

Affiliation(s): Department of Ophthalmology, Kagoshima University Graduate School of Medical and Dental Science, Sakuragaoka 8-35-1, Kagoshima 890-8520, Japan.

Publication date & source: 2008-07, Graefes Arch Clin Exp Ophthalmol., 246(7):959-66. Epub 2008 Apr 23.

Publication type: Multicenter Study; Randomized Controlled Trial; Research Support, Non-U.S. Gov't

PURPOSE: To evaluate the 1-year results of using triamcinolone acetonide (TA) in pars plana vitrectomy (PPV). DESIGN: Multicenter prospective controlled clinical trial. METHODS: SETTING and STUDY POPULATION: the study population comprised 774 eyes from patients treated at eight Japanese hospitals, among which 391 eyes underwent TA-assisted PPV and 383 control eyes underwent conventional PPV. The patients were assigned to the two groups using a single-blind quasi-randomization approach within the participating clinical centers. INTERVENTION: intra-operative use of TA to aid visualization of the vitreous. MAIN OUTCOME MEASURES: changes of visual acuity, post-operative complications (including additional surgery), and adverse events occurring within 1 year of the operation were compared between the TA-PPV group and the conventional PPV group. RESULTS: The visual acuity improved over time, and no significant differences were found between the two groups (log-rank versus TA, P = 0.98 for improvement, P = 0.26 for deterioration). The logistic regression model also showed that the intra-operative use of TA was not a significant factor for the improvement of visual acuity [P = 0.91, odds ratio (OR) = 1.10, 95% confidence interval (95%CI) = 0.860-1.183)] after adjustments for age, gender, and diagnosis. Intra-operative TA was not a significant factor for the need for additional surgery (log-rank test P = 0.45, logistic regression test P = 0.35, OR = 1.23, 95%CI = 0.797-1.911]. No serious adverse events related to surgery were observed. CONCLUSIONS: This 1-year follow-up study of a controlled clinical trial showed that TA-assisted PPV had neither a positive nor a negative effect on visual acuity, the incidence of additional surgeries, or adverse events compared with conventional PPV.

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