Outcomes of Intraoperative 5-Fluorouracil Versus Mitomycin C
- Conditions
- Glaucoma
- Registration Number
- NCT00346489
- Lead Sponsor
- Indiana University School of Medicine
- Brief Summary
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.
- 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.
Recruitment & Eligibility
- Status
- COMPLETED
- Sex
- All
- Target Recruitment
- 70
- 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.
- 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 & Design
- Study Type
- INTERVENTIONAL
- Study Design
- PARALLEL
- Primary Outcome Measures
Name Time Method Pressure Control
- Secondary Outcome Measures
Name Time Method Mitomycin Complications
Trial Locations
- Locations (2)
University Hospital and Outpatient Center
🇺🇸Indianapolis, Indiana, United States
IU Eye at Carmel
🇺🇸Indianapolis, Indiana, United States