期刊
PLOS ONE
卷 12, 期 2, 页码 -出版社
PUBLIC LIBRARY SCIENCE
DOI: 10.1371/journal.pone.0171636
关键词
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资金
- MSD SHARP & DOHME GmbH, Germany
- Santen Pharmaceutical Co., Ltd., Japan
- Augenarzte im Basteicenter
Introduction To demonstrate that preoperative treatment for 28 days with topical dorzolamide/timolol is non-inferior (Delta = 4 mm Hg) to oral acetazolamide and topical dexamethasone (standard therapy) in terms of intraocular pressure (10P) 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 mono centric prospective randomized controlled study. 10P 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 10P 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 10P 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.
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