Efficacy and safety of preoperative IOP reduction using a preservative-free fixed combination of dorzolamide-timolol eye drops versus oral acetazolamide and dexamethasone eye drops and assessment of the clinical outcome of trabecuReport as inadecuate




Efficacy and safety of preoperative IOP reduction using a preservative-free fixed combination of dorzolamide-timolol eye drops versus oral acetazolamide and dexamethasone eye drops and assessment of the clinical outcome of trabecu - Download this document for free, or read online. Document in PDF available to download.

Introduction

To demonstrate that preoperative treatment for 28 days with topical dorzolamide-timolol is non-inferior Δ = 4 mm Hg to oral acetazolamide and topical dexamethasone standard therapy in terms of intraocular pressure IOP reduction 3 and 6 months after trabeculectomy in glaucoma patients.

Materials and methods

Sixty-two eyes undergoing trabeculectomy with mitomycin C were included in this monocentric prospective randomized controlled study. IOP change between baseline and 3 months post-op was defined as the primary efficacy variable. Secondary efficacy variables included the number of 5-fluorouracil 5-FU injections, needlings, suture lyses, preoperative IOP change, hypertension rate and change of conjunctival redness 3 and 6 months post-op. Safety was assessed based on the documentation of adverse events.

Results

Preoperative treatment with topical dorzolamide-timolol was non-inferior to oral acetazolamide and topical dexamethasone in terms of IOP reduction 3 months after trabeculectomy adjusted means -8.12 mmHg versus -8.30 mmHg; Difference: 0.18; 95% CI -1.91 to 2.26, p = 0.8662. Similar results were found 6 months after trabeculectomy -9.13 mmHg versus -9.06 mmHg; p = 0.9401. Comparable results were also shown for both groups concerning the classification of the filtering bleb, corneal staining, and numbers of treatments with 5-FU, needlings and suture lyses. More patients reported AEs in the acetazolamide-dexamethasone group than in the dorzolamide-timolol group.

Discussion

Preoperative, preservative-free, fixed-dose dorzolamide-timolol seems to be equally effective as preoperative acetazolamide and dexamethasone and has a favourable safety profile.



Author: Katrin Lorenz , Joanna Wasielica-Poslednik, Katharina Bell, Giulia Renieri, Alexander Keicher, Christian Ruckes, Norbert Pfeiffer

Source: http://plos.srce.hr/



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