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Outcomes of Intraoperative 5-Fluorouracil Versus Mitomycin C

Information source: Indiana University
ClinicalTrials.gov processed this data on August 23, 2015
Link to the current ClinicalTrials.gov record.

Condition(s) targeted: Glaucoma

Intervention: 5-fluorouracil (Drug); Mitomycin C (Drug)

Phase: Phase 4

Status: Completed

Sponsored by: Indiana University School of Medicine

Official(s) and/or principal investigator(s):
Louis B Cantor, MD, Principal Investigator, Affiliation: IUPUI/Clarian

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.

Clinical Details

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

Study design: Allocation: Randomized, Endpoint Classification: Bio-equivalence Study, Intervention Model: Parallel Assignment, Masking: Double-Blind, Primary Purpose: Treatment

Primary outcome: Pressure Control

Secondary outcome: Mitomycin Complications

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

Minimum age: N/A. Maximum age: N/A. Gender(s): Both.

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.

Locations and Contacts

IU Eye at Carmel, Indianapolis, Indiana 46290, United States

University Hospital and Outpatient Center, Indianapolis, Indiana 46202, United States

Additional Information

Related publications:

Skuta GL, Beeson CC, Higginbotham EJ, Lichter PR, Musch DC, Bergstrom TJ, Klein TB, Falck FY Jr. Intraoperative mitomycin versus postoperative 5-fluorouracil in high-risk glaucoma filtering surgery. Ophthalmology. 1992 Mar;99(3):438-44.

Kitazawa Y, Kawase K, Matsushita H, Minobe M. Trabeculectomy with mitomycin. A comparative study with fluorouracil. Arch Ophthalmol. 1991 Dec;109(12):1693-8.

Palmer SS. Mitomycin as adjunct chemotherapy with trabeculectomy. Ophthalmology. 1991 Mar;98(3):317-21.

Dunn JP, Seamone CD, Ostler HB, Nickel BL, Beallo A. Development of scleral ulceration and calcification after pterygium excision and mitomycin therapy. Am J Ophthalmol. 1991 Sep 15;112(3):343-4.

Fluorouracil Filtering Surgery Study one-year follow-up. The Fluorouracil Filtering Surgery Study Group. Am J Ophthalmol. 1989 Dec 15;108(6):625-35.

Liebmann JM, Ritch R, Marmor M, Nunez J, Wolner B. Initial 5-fluorouracil trabeculectomy in uncomplicated glaucoma. Ophthalmology. 1991 Jul;98(7):1036-41.

Lee DA, Hersh P, Kersten D, Melamed S. Complications of subconjunctival 5-fluorouracil following glaucoma filtering surgery. Ophthalmic Surg. 1987 Mar;18(3):187-90.

Knapp A, Heuer DK, Stern GA, Driebe WT Jr. Serious corneal complications of glaucoma filtering surgery with postoperative 5-fluorouracil. Am J Ophthalmol. 1987 Feb 15;103(2):183-7.

Khaw PT, Sherwood MB, MacKay SL, Rossi MJ, Schultz G. Five-minute treatments with fluorouracil, floxuridine, and mitomycin have long-term effects on human Tenon's capsule fibroblasts. Arch Ophthalmol. 1992 Aug;110(8):1150-4.

Khaw PT, Doyle JW, Sherwood MB, Grierson I, Schultz G, McGorray S. Prolonged localized tissue effects from 5-minute exposures to fluorouracil and mitomycin C. Arch Ophthalmol. 1993 Feb;111(2):263-7.

Khaw PT, Doyle JW, Sherwood MB, Smith MF, McGorray S. Effects of intraoperative 5-fluorouracil or mitomycin C on glaucoma filtration surgery in the rabbit. Ophthalmology. 1993 Mar;100(3):367-72.

Lanigan L, Stürmer J, Baez KA, Hitchings RA, Khaw PT. Single intraoperative applications of 5-fluorouracil during filtration surgery: early results. Br J Ophthalmol. 1994 Jan;78(1):33-7.

Dietze PJ, Feldman RM, Gross RL. Intraoperative application of 5-fluorouracil during trabeculectomy. Ophthalmic Surg. 1992 Oct;23(10):662-5.

Egbert PR, Williams AS, Singh K, Dadzie P, Egbert TB. A prospective trial of intraoperative fluorouracil during trabeculectomy in a black population. Am J Ophthalmol. 1993 Nov 15;116(5):612-6.

Smith MF, Doyle JW, Nguyen QH, Sherwood MB. Results of intraoperative 4 fluorouracil or low dose MMC supplementation on primary trabeculectomy surgery. Invest Ophthalmol & Visual Science. 1996,37;#3:S25(Abstract #108).

Singh K, Mehta K, Shaikh NM, Tsai JC, Moster MR, Budenz DL, Greenfield DS, Chen PP, Cohen JS, Baerveldt GS, Shaikh S. Trabeculectomy with intraoperative mitomycin C versus 5-fluorouracil. Prospective randomized clinical trial. Ophthalmology. 2000 Dec;107(12):2305-9.

Spaeth GL, Mutlukan E. The use of antimetabolites with trabeculectomy: a critical appraisal. J Glaucoma. 2001 Jun;10(3):145-51. Review.

WuDunn D, Cantor LB, Palanca-Capistrano AM, Hoop J, Alvi NP, Finley C, Lakhani V, Burnstein A, Knotts SL. A prospective randomized trial comparing intraoperative 5-fluorouracil vs mitomycin C in primary trabeculectomy. Am J Ophthalmol. 2002 Oct;134(4):521-8.

Starting date: September 2004
Last updated: December 21, 2007

Page last updated: August 23, 2015

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