Intraoperative episcleral versus postoperative topical application of mitomycin-C for trabeculectomies.
rct · Level II
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Abstract
To assess the efficacy of a new application technique of mitomycin-C to enhance the outcome of filtering surgery in cases of complicated glaucoma. Randomized clinical trial. Fifty consecutive patients scheduled for glaucoma surgery in one large surgical center. Patients underwent routine trabeculectomy. In group 1, mitomycin-C (0.05 mg/ml) was applied topically to the filtering bleb on days 1, 2, and 3 after surgery (postoperative application). In group 2, mitomycin-C (0.2 mg/ml) was applied by means of to a sponge during surgery (intraoperative application). Preoperative and postoperative intraocular pressure (IOP) values, visual acuity, the need for antiglaucoma medication, previous surgical procedures, and the need for further surgical interventions were monitored. Sufficient follow-up data were available from 24 of 25 patients in each of the two groups. The follow-up ranged from 12 to 28 months and was evaluated at 12 months for all patients. The mean IOP decreased from 27.3 to 15.5 mmHg in group 1 and from 29.0 to 17.5 mmHg in group 2. The average number of medications decreased from 2.3 and 2.4 to 0.9 and 0.8 (P = 0.68; t test) in groups 1 and 2, respectively, at the 12-month visit. Hypotony was more frequent in group 2, in which the only case of hypotony maculopathy occurred. There was a tendency of more eyes with lower IOP values in this group. The rate of loss of visual acuity of more than 2 lines was higher in group 2. Failures were more frequent in group 2 (7 of 24) compared with group 1 (1 of 24) (P = 0.04, chi-square test). To our knowledge, this is the first prospective, randomized clinical study to evaluate the efficacy of this different technique of mitomycin-C application. The postoperative application of mitomycin-C was effective, having few failures. This application of mitomycin-C may be associated with a lower rate of complications when used in eyes with complicated forms of glaucoma.
Medical subject headings
- Antibiotics, Antineoplastic
- Glaucoma, Open-Angle
- Mitomycin
- Sclera
- Trabeculectomy