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OBJECTIVE: The objective of the study was to compare the efficacy and safety of topical dexamethasone sodium phosphate 0.1% (Sterodex) to diclofenac sodium 0.1% (Voltaren Ophthalmic) after combined phacotrabeculectomy with mitomycin C. METHODS: This prospective, randomized, double-masked clinical trial includes 42 patients with glaucoma and cataract who underwent a combined phacotrabeculectomy. Patients were randomly assigned to postoperative treatment with topical diclofenac sodium 0.1% or topical dexamethasone phosphate 0.1%. Follow-up duration was 12 months and all examinations were masked. The main outcome measures were intraocular pressure (IOP), number of glaucoma medications, and bleb morphology. RESULTS: Baseline characteristics of the diclofenac (n=21) and dexamethasone (n=21) patients were similar. Phacotrabeculectomy with both postoperative treatments was effective in reducing IOP, lowering the number of glaucoma medications and improving visual acuity at all follow-up points. The average number of medications taken by the dexamethasone group was significantly greater than the diclofenac group at 8 months (1.2(plus or minus)1.4 and 0.3(plus or minus)0.6, respectively, P=0.03). The mean bleb height of the diclofenac group was significantly higher than the dexamethasone group at 3 weeks (P=0.05), and the mean bleb width was significantly wider at 8 months (P=0.04). No significant group differences in IOP were found at any of the follow-up visits, although there was a clinical trend toward lower IOP values in the diclofenac group. Sixteen patients (76%) in the diclofenac group and 17 patients in the dexamethasone group (81%) completed 1 year of follow-up. CONCLUSIONS: In this preliminary study, diclofenac sodium is at least as good as topical dexamethasone phosphate for glaucoma patients undergoing two-site combined phacotrabeculectomy with mitomycin C.
H. Levkovitch-Verbin.
12.14.3 Phacoemulsification (Part of: 12 Surgical treatment > 12.14 Combined cataract extraction and glaucoma surgery)