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Yosuke Sugimoto, Hideki Mochizuki, Shinji Ohkubo, Tomomi Higashide, Kazuhisa Sugiyama, Yoshiaki Kiuchi; Trabeculectomy with Mitomycin C: Outcomes and Risk Factors for Failure in the Collaborative Bleb-related Infection Incidence and Treatment Study. Invest. Ophthalmol. Vis. Sci. 2014;55(13):3157.
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To evaluate the efficacy and safety of current trabeculectomy surgery as part of the Collaborative Bleb-related Infection Incidence and Treatment Study in Japan.
A total of 975 eyes of 975 glaucoma patients who had undergone trabeculectomy or trabeculectomy combined with phacoemulsification and intraocular lens implantation performed at 34 clinical centers were included in the study. Outcomes were measured at six-month intervals. Three levels of success were defined by these criteria: (A) 4 < IOP < 22 mmHg and a 20% reduction of the preoperative IOP; (B) 4 < IOP < 16 mmHg and a 20% reduction of the preoperative IOP and (C) 4 < IOP < 16 mmHg and a 30% reduction of the preoperative IOP. The Kaplan-Meier survival analyses were used to assess the outcomes. A Cox's proportional hazard regression analysis was used to identify the risk factors for failure. The primary outcome was the qualified success rate according to the defined criteria. The secondary outcomes included the IOP and number of medications required after surgery, postoperative complications and the need for further glaucoma surgery.
The mean IOP and preoperative antiglaucomatous medications were significantly decreased from 25.5 ± 9.5 mmHg and 3.0 ± 1.2 to 12.6 ± 5.2 mmHg and 1.2 ± 1.3 five years after surgery, respectively (p< 0.0001, p< 0.0001, respectively). The success rates were 60%, 48.7% and 43.6% at three years for criteria A, B and C, respectively; and were 49.5%, 37.1% and 32.6% for these criteria, respectively, at five years. The complications noted during the follow-up included hyphema in 28 eyes (2.9%), a shallow anterior chamber in 32 eyes (3.3%), bleb leaks in 42 eyes (4.3%), choroidal detachment in 66 eyes (6.8%) and hypotony in 30 eyes (3.1%). Postoperative hypotony was associated with a higher rate of failure for criteria A and C (P = 0.05 and 0.03, respectively), with the hazard ratios (HRs) being 1.90 for criteria A and 1.67 for criteria C. Intraoperative hyphema was associated with a higher risk of failure for criteria C (HR = 2.57; P = 0.03).
This study shows that low rates of surgical complications can be achieved at the five-year follow-up for trabeculectomy. Postoperative hypotony and intraoperative hyphema are associated with a higher risk of failure.
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