CI

At a glance

ClinicalIndex Comparison Record
Phase 4Completed· 100 enrolled
Drug / intervention
Mitomycin-C injection +1 moredrug
Likely dose
Mitomycin-C delivered either by preoperative subconjunctival injection or intraoperative direct scleral application with impregnated cellulose spongesAI-extracted
Key inclusion· 2
  • Medically uncontrolled glaucoma despite pharmacologic therapy
  • Healthy and freely mobile conjunctiva in the superior bulbar region (required for surgical access)
Key exclusion· 8
  • Prior incisional glaucoma surgery
  • No light perception vision
  • Pregnant or nursing women
  • Iris neovascularization or proliferative retinopathy

Standardized by ClinicalIndex from the ClinicalTrials.gov record · verify against the source.

Search/NCT04352660
NCT04352660Phase 4Completed

Subconjunctival Versus Direct Scleral Application of Mitomycin-C in Trabeculectomy

University of California, San Diego·interventional·Posted Apr 20, 2020·Updated Jul 2, 2020

In Brief

A Phase 4 clinical trial evaluating Mitomycin-C injection and Mitomycin-C sponge for Open Angle Glaucoma. Completed, enrolled 100 participants.

Detailed Summary

Trabeculectomy is routinely used as a surgical treatment for open angle glaucoma. Success of trabeculectomy is greatly augmented by the use of antimetabolites to inhibit wound healing, specifically Mitomycin C (MMC). MMC can be applied to the eye at various sites, concentrations and times. This study aims to compare the two application routes that are commonly employed: subconjunctival pre-operative injection and intraoperative direct scleral application in terms of IOP lowering effect, bleb appearance and complications.

Study Details

Study Typeinterventional
Allocation--
Masking--
Primary Purpose--
Countries--
Collaborators--

Timeline

Phase 4CompletedFinished
2017201820192020202120222023202420252026
First PostedApr 20, 2020
Enrollment StartMay 23, 2016
Primary CompletionApr 14, 2019
TodayJul 2, 2026
Enrollment to primary: 2.9 yearsPosted 6.2 years ago

Interventions

Mitomycin-C injectiondrug

MMC delivered by preoperative subconjunctival injection

Mitomycin-C spongedrug

MMC delivered by intraoperative direct scleral application with impregnated cellulose sponges