NCT00346489

Outcomes of Intraoperative 5-Fluorouracil Versus Mitomycin C

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

• Status: Completed
• Phase: Phase 4
• Study type: Interventional
• Enrollment: 70 (planned)
• Sponsor: Indiana University School of Medicine · Academic / Other
• Sex: All
• Age: —
• Healthy volunteers: Not accepted

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.

Conditions

• Glaucoma

Interventions

Type	Name	Description
DRUG	5-fluorouracil
DRUG	Mitomycin C

Timeline

• Start date: 2004-09-01
• Primary completion: 2007-08-01
• Completion: 2007-08-01
• First posted: 2006-06-30
• Last updated: 2007-12-27

Locations

2 sites across 1 country: United States