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Subconjunctival Versus Direct Mitomycin C in Trabeculectomy

NCT04352660 · Status: COMPLETED · Phase: PHASE4 · Type: INTERVENTIONAL · Enrollment: 100

Last updated 2020-07-02

Study results available
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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.

Conditions

Interventions

DRUG

Mitomycin-C injection

MMC delivered by preoperative subconjunctival injection

DRUG

Mitomycin-C sponge

MMC delivered by intraoperative direct scleral application with impregnated cellulose sponges

Sponsors & Collaborators

Principal Investigators

  • Jiun L Do, MD, PhD · UCSD

  • Robert N Weinreb, MD · UCSD

  • Benjamin Xu, MD, PhD · UCSD

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
SINGLE
Model
PARALLEL

Eligibility

Min Age
18 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2016-05-23
Primary Completion
2019-04-14
Completion
2019-04-14
FDA Drug
Yes

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Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT04352660 on ClinicalTrials.gov