PURPOSE: To evaluate the benefits and potential complications of using triamcinolone acetonide (TA) in pars plana vitrectomy (PPV). DESIGN: Multicenter, prospective, controlled clinical trial. PARTICIPANTS: In total, 774 patients from 8 Japanese hospitals were enrolled, with 391 patients undergoing TA-assisted PPV and 383 control patients undergoingconventional PPV. INTERVENTION: Intraoperative use of TA to aid visualization of the vitreous. MAIN OUTCOME MEASURES: The incidence of intraoperative complications, including retinal breaks, was evaluated. Early postoperative complications, intraocular pressure (IOP), and adverse events occurring within 3 months of the operation were also monitored. RESULTS: The incidence of both retinal breaks and intraoperative retinal detachment was significantly lower in TA-assisted PPV than in conventional PPV. Retinal breaks were seen in 34 eyes (8.7%) undergoing TA-assisted PPV compared with 54 eyes (14.1%) undergoing conventional PPV (odds ratio [OR], 0.603; 95% confidence interval [CI], 0.381-0.955; P = 0.031). Retinal detachment was seen in only 3 eyes (0.8%) in which TA was used compared with 14 eyes (3.7%) in which TA was not used (OR, 0.204; 95% CI, 0.057-0.727; P = 0.014). In total, 388 eyes in the TA-assisted PPV group (99.2%) and 374 eyes in theconventional PPV group (97.6%) were followed up for 3 months after the operation. Although the mean postoperative IOPs were comparable in both groups, antiglaucoma eye drops were used more frequently by patients in the TA-assisted group than by those in the conventional PPV group (OR, 1.673; 95% CI, 1.126-2.484; P = 0.011). No serious adverse events, such as endophthalmitis or retinal degeneration, were observed in either group. CONCLUSIONS: Intraoperative use of TA reduced the incidence of retinal breaks and retinal detachments in eyes undergoing PPV. There were no serious adverse events related to the intraoperative use of TA. Although antiglaucoma eye drops were required more frequently after TA-assisted PPV than after conventional PPV, IOP was well-controlled in both groups.
RCT Entities:
PURPOSE: To evaluate the benefits and potential complications of using triamcinolone acetonide (TA) in pars plana vitrectomy (PPV). DESIGN: Multicenter, prospective, controlled clinical trial. PARTICIPANTS: In total, 774 patients from 8 Japanese hospitals were enrolled, with 391 patients undergoing TA-assisted PPV and 383 control patients undergoing conventional PPV. INTERVENTION: Intraoperative use of TA to aid visualization of the vitreous. MAIN OUTCOME MEASURES: The incidence of intraoperative complications, including retinal breaks, was evaluated. Early postoperative complications, intraocular pressure (IOP), and adverse events occurring within 3 months of the operation were also monitored. RESULTS: The incidence of both retinal breaks and intraoperative retinal detachment was significantly lower in TA-assisted PPV than in conventional PPV. Retinal breaks were seen in 34 eyes (8.7%) undergoing TA-assisted PPV compared with 54 eyes (14.1%) undergoing conventional PPV (odds ratio [OR], 0.603; 95% confidence interval [CI], 0.381-0.955; P = 0.031). Retinal detachment was seen in only 3 eyes (0.8%) in which TA was used compared with 14 eyes (3.7%) in which TA was not used (OR, 0.204; 95% CI, 0.057-0.727; P = 0.014). In total, 388 eyes in the TA-assisted PPV group (99.2%) and 374 eyes in the conventional PPV group (97.6%) were followed up for 3 months after the operation. Although the mean postoperative IOPs were comparable in both groups, antiglaucoma eye drops were used more frequently by patients in the TA-assisted group than by those in the conventional PPV group (OR, 1.673; 95% CI, 1.126-2.484; P = 0.011). No serious adverse events, such as endophthalmitis or retinal degeneration, were observed in either group. CONCLUSIONS: Intraoperative use of TA reduced the incidence of retinal breaks and retinal detachments in eyes undergoing PPV. There were no serious adverse events related to the intraoperative use of TA. Although antiglaucoma eye drops were required more frequently after TA-assisted PPV than after conventional PPV, IOP was well-controlled in both groups.