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Outcomes of Intraoperative 5-Fluorouracil Versus Mitomycin C

Phase 4CompletedNCT00346489
Indiana University School of Medicine70 enrolled

Overview

A clinical trial to establish the long term response of using intraoperative 5-fluorouracil (5-FU) versus mitomycin C (MMC) in trabeculectomy glaucoma surgery. Antiproliferative agents such as 5-fluorouracil and Mitomycin C have been used extensively in trabeculectomy surgery to improve the success of the surgery and prevent further visual loss and blindness in glaucoma patients.

Glaucoma is a life-long progressive disease, and patients are living longer. Therefore, a long term full evaluation of the efficacy of intraoperative 5-FU and MMC needs to be performed to assess the true efficacy of MMC compared to 5-FU. We, therefore propose, a long-term prospective study of patients previously enrolled in the prospective study involving the evaluation of single intraoperative application of mitomycin C versus 5-fluorouracil in low to moderate risk glaucoma patients.

Study Type

INTERVENTIONAL

Allocation

RANDOMIZED

Purpose

TREATMENT

Masking

DOUBLE

Enrollment

70

Conditions

Glaucoma

Interventions

5-fluorouracilDRUG
Mitomycin CDRUG

Eligibility

Sex: ALL
Medical Language ↔ Plain English
Inclusion Criteria: * Only patients deemed successful as 36 months will be included. These patients will have participated in the randomized prospective study trial comparing intraoperative 5-FU and mitomycin C in primary trabeculectomy. Exclusion Criteria: * Only patients deemed successful as 36 months will be included. These patients will have participated in the randomized prospective study trial comparing intraoperative 5-FU and mitomycin C in primary trabeculectomy.

Locations (2)

University Hospital and Outpatient Center

Indianapolis, Indiana, United States

IU Eye at Carmel

Indianapolis, Indiana, United States

Outcomes

Primary Outcomes

Pressure Control

Secondary Outcomes

Mitomycin Complications

Data from ClinicalTrials.gov

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