Abstract
Abstract: :
Purpose: To assess the efficacy of a new application technique of mitomycin to enhance the outcome of filtering surgery in cases of uncontrolled glaucoma in eyes without previous filtering surgery. Methods: This is a prospective, randomized clinical trial. Forty-two consecutive patients scheduled for glaucoma surgery in one large surgical center were included on a consecutive basis. Patients underwent routine trabeculectomy. On the day of surgery, the surgeon was not aware to which of the two groups a patient belonged, nor was the study supervisor. In group 1, mitomycin (0.05mg/ml) was applied topically to the filtering bleb on the three days after surgery (postoperative application). In group 2, no mitomycin was applied. Pre- and post- operative IOP values, visual acuity, the need for antiglaucomatous medication, previous surgical procedures and the need for further surgical interventions were monitored. Patients were followed by their ophthalmologists and / or in our Glaucoma Center of the Department. Results: Sufficient follow-up data was available from all patients in both groups (100%). Mean follow- up was 8.5 months (range, 4-14 months) and 8.7 months (range, 2-19 months), respectively for groups 1 and 2. The mean IOP decreased from 30.5±10.2mmHg to 14.8±2.8mmHg in group 1 and from 23.1±7.1mmHg to 16.3±4.1mmHg in group 2. The mean visual acuity changed from 0.42 to 0.47 (decimals) in group 1 and from 0.46 to 0.45 in group 2. The average amount of medications decreased from 2.3±1.1 to 0.1±0.4 in group 1 and from 2.3±1.0 to 0.7±1.1 in group 2. The difference in the need for topical antiglaucomatous therapy at the last follow-up was significant (p=0.02, t-test). Complications such as failures and the need for further surgical procedures occurred once in group 1 and four times in group 2 (not significant, Mann-Whitney test). Enhancement procedures such as suture lysis and revision of the filtering bleb were infrequent and not different between the two groups. Postoperative hypotony (IOD of less than 5mmHg) was frequent with 13 cases in group 1 and 11 cases in group 2. No case of hypotony maculopathy developed. Conclusions: The postoperative application of mitomycin made no change when compared to no application in terms of surgical failures. The need for further antiglaucomatous therapy (complete surgical success vs. qualified surgical success) seemed to be larger in the non- mitomycin treated group. It appears therefore, that the topical postoperative application of a low dose of mitomycin improves the rate of patients with a complete surgical success.
Keywords: 357 clinical (human) or epidemiologic studies: treatment/prevention assessment/controlled clinical trials • 444 intraocular pressure • 631 wound healing