drugset / Trial / NCT02016898

The Effect of Sponge Versus No-Sponge Placement of Mitomycin-C on the Outcomes of Trabeculectomy With Ex-PRESS Glaucoma Filtration Device

NCT02016898 ↗

Phase 2 Completed 100 enrolled Duke University
RandomizedParallel-groupDouble-blindTreatment

Summary

The primary focus of this study is to assess intraocular pressure and complication rates between patients who receive mitomycin-C using a sponge versus no-sponge.

Timeline

Start
2014-03
Primary completion
2017-01-17
Completion
2017-01-17

Outcome

Missed primary endpoint

registry analysis (other test); Sponge Placement of Mitomycin-C vs Irrigation Placement of MMC; p = 0.7; Risk Ratio (RR) 0.93 (95% CI 0.67 to 1.29); Chi-squared NCT02016898 ↗

Drugs

EvaluationDrugModalityDoseRoute
Subject Mitomycin C Other / unclassified — Other

Indications