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Mitomycin Applied Topically For Primary Trabeculectomy

1Mietz H., 1Jacobi P. C., 1Jonescu-Cuypers C., 2Welsandt G., 1Krieglstein G. K.,
1Universität zu Köln, Zentrum für Augenheilkunde (Köln)
2Universität zu Köln, Zentrum für Augenheilkunde, Abteilung für Netzhaut- und Glaskörperchirurgie (Köln)

Objective: 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: We performed 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.
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.
Conclusions: 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. This application of mitomycin does not increase the rate of complications.

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