Abstract
Purpose :
Controversy exists regarding the optimal preoperative preparation prior to planned trabeculectomy (TE) in glaucoma patients. We compared our standard therapy (stopping topical antiglaucoma drugs for 28 days, controlling intraocular pressure (IOP) with oral acetazolamide, and topical dexamethasone for 7 days) with topical, preservative-free, fixed-dose dorzolamide/timolol. This monocentic, prospective, randomized study was performed to demonstrate non-inferiority (Δ = 4 mm Hg) of dorzolamide/timolol to standard therapy in terms of IOP reduction, safety and quality of life 3 and 6 months after TE.
Methods :
Sixty-two eyes of 62 patients (≥ 18 years; diagnosis of primary open-angle glaucoma, pseudoexfoliation glaucoma or pigmentary glaucoma) undergoing TE with mitomycin C were included in this study. Patients were randomized into 1 of 2 treatment arms: a) dorzolamide/timolol; b) acetazolamide/dexamethasone. 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 (AE).
Results :
Preoperative treatment with topical dorzolamide/timolol was non-inferior to oral acetazolamide and topical dexamethasone in terms of IOP reduction 3 months after TE (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 TE (-9.13 mmHg versus -9.06 mmHg; p=0.9401). Both groups had similar results concerning the appearance of the filtering bleb, corneal staining, and numbers of treatments with 5-FU, needlings and suture lyses. But more patients reported AEs in the acetazolamide/dexamethasone group than in the dorzolamide/timolol group.
Conclusions :
Preoperative dorzolamide/timolol is equally effective as preoperative acetazolamide/dexamethasone and has a favourable safety profile. Both groups showed a similar bleb appearance. Quality of life assessment scores favoured treatment with dorzolamide/timolol.
This is an abstract that was submitted for the 2017 ARVO Annual Meeting, held in Baltimore, MD, May 7-11, 2017.