Journal Article

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 trabeculectomy in glaucoma

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

2017

Overview

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

• Publisher: Public Library of Science,Public Library of Science (PLoS)
• Subject: 5-Fluorouracil / Acetazolamide / Acetazolamide - administration & dosage / Acetazolamide - pharmacology / Aged / Analysis / Antihypertensive Agents - therapeutic use / Archives & records / Biology and Life Sciences / Care and treatment / Comparative analysis / Competent authority / Cornea / Dexamethasone / Dexamethasone - administration & dosage / Dexamethasone - pharmacology / Dorzolamide / Dosage and administration / Drug Combinations / Drugs / Effectiveness / Eye / Female / Filtration / Fluorouracil - therapeutic use / Glaucoma / Glaucoma - drug therapy / Glaucoma - pathology / Glaucoma - surgery / Health aspects / Humans / Hypertension / Intraocular pressure / Intraocular Pressure - drug effects / Intraoperative monitoring / Male / Medicine and Health Sciences / Mercury / Middle Aged / Mitomycin C / Ocular Hypertension - drug therapy / Ophthalmic Solutions - administration & dosage / Ophthalmic Solutions - pharmacology / Ophthalmology / Patients / Potassium / Preoperative Care / Preservatives / Prospective Studies / Reduction / Research and Analysis Methods / Safety / Safety and security measures / Steroids / Success / Sulfonamides - administration & dosage / Sulfonamides - pharmacology / Surgeons / Surgery / Thiophenes - administration & dosage / Thiophenes - pharmacology / Timolol / Timolol - administration & dosage / Timolol - pharmacology / Trabeculectomy / Treatment Outcome