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

Abstract

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. © Springer-Verlag 2008.