Clinical trial NCT00346489: Outcomes of Intraoperative 5-Fluorouracil Versus Mitomycin C
Official title: Intermediate Term Outcomes of Intraoperative 5-Fluorouracil Versus Mitomycin c in Trabeculectomy Surgery.
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE4
Conditions: Glaucoma
Keywords: Trabeculectomy
5-fluorouracil
Mitomycin C
Lead sponsor: Indiana University
Sponsor class: OTHER
First posted: 2006-06-30
Enrollment: 70
Sex: ALL
Standard ages: CHILD
ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

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.

Eligibility criteria: 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.

Primary outcomes:
measure: Pressure Control
Secondary outcomes:
measure: Mitomycin Complications
Other outcomes:
Locations:
city: Indianapolis
country: United States
facility: University Hospital and Outpatient Center
state: Indiana
city: Indianapolis
country: United States
facility: IU Eye at Carmel
state: Indiana
Study officials:
affiliation: IUPUI/Clarian
name: Louis B Cantor, MD
role: PRINCIPAL_INVESTIGATOR
References:
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