Outcomes of Intraoperative 5-Fluorouracil Versus Mitomycin C

December 21, 2007 updated by: Indiana University School of Medicine

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

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.

Study Overview

Status

Completed

Conditions

Intervention / Treatment

Detailed Description

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

Enrollment

70

Phase

  • Phase 4

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • United States
    • Indiana
      • Indianapolis, Indiana, United States, 46290
        • IU Eye at Carmel
      • Indianapolis, Indiana, United States, 46202
        • University Hospital and Outpatient Center

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

  • Child
  • Adult
  • Older Adult

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

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.

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: Double

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Pressure Control

Secondary Outcome Measures

Outcome Measure
Mitomycin Complications

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Indiana University School of Medicine

Investigators

  • Principal Investigator: Louis B Cantor, MD, IUPUI/Clarian

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

September 1, 2004

Primary Completion (Actual)

August 1, 2007

Study Completion (Actual)

August 1, 2007

Study Registration Dates

First Submitted

June 28, 2006

First Submitted That Met QC Criteria

June 28, 2006

First Posted (Estimate)

June 30, 2006

Study Record Updates

Last Update Posted (Estimate)

December 27, 2007

Last Update Submitted That Met QC Criteria

December 21, 2007

Last Verified

December 1, 2007

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • 0409-60

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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