Interim clinical outcomes in the collaborative bleb-related infection incidence and treatment study.

PURPOSE

To introduce the Collaborative Bleb-related Infection Incidence and Treatment Study and to provide an interim, 2.5-year follow-up report of the findings. This prospective study sought to determine the incidence, severity, and prognosis of bleb-related infection and to investigate the efficacy of the antibacterial therapy in preventing it.

DESIGN

Prospective cohort study.

PARTICIPANTS

A total of 908 eyes of 908 glaucoma patients who had undergone mitomycin C-augmented trabeculectomy or trabeculectomy combined with phacoemulsification and intraocular lens implantation performed at 34 clinical centers.

METHODS

Outcomes were measured at 6-month intervals, with special attention to bleb-related infections, and data for 2.5 years of follow-up result were summarized.

MAIN OUTCOME MEASURES

The incidence and severity of bleb-related infection.

RESULTS

Of the 908 eyes, 9 eyes developed a bleb-related infection. The Kaplan-Meier survival analysis revealed that the probability of development of bleb-related infection was 1.5±0.6% (cumulative probability ± standard error) at the 2.5-year follow in the trabeculectomy cases and 1.4±1.0% in the combined surgery cases. It was 1.5% in both cases with a limbal-based flap and in those with a fornix-based flap. It was significantly different between cases with bleb leakage and those without it (P = 0.037; log-rank test).

CONCLUSIONS

The cumulative probability of bleb-related infection was prospectively determined to be 1.5±0.6% in eyes treated with mitomycin C-augmented trabeculectomy or trabeculectomy combined with phacoemulsification and intraocular lens implantation at the 2.5-year follow-up in the Collaborative Bleb-related Infection Incidence and Treatment Study.