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Completed

NCT Number: NCT00346489

Outcomes of Intraoperative 5-Fluorouracil Versus Mitomycin C

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.

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Key information

Conditions

Glaucoma Eye Diseases Ocular Hypertension

Sex eligibility

All sexes

Study type

Interventional

Phase

Phase 4

Primary location

IU Eye at Carmel, Indianapolis, Indiana, United States

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About this study

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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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.

Treatment and study plan

5-fluorouracil

Drug

mitomycin C

Drug

Primary outcomes

  1. Pressure Control

Secondary outcomes

  1. Mitomycin Complications

Sponsors and collaborators

Lead sponsor

Indiana University

Other

Registry information

Official study title

Intermediate Term Outcomes of Intraoperative 5-Fluorouracil Versus Mitomycin c in Trabeculectomy Surgery.

Important dates

Study start
2004
Primary completion
2007
Study completion
2007
First posted
Jun 30, 2006
Registry last updated
Dec 27, 2007

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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