June 2017
Volume 58, Issue 8
Open Access
ARVO Annual Meeting Abstract  |   June 2017
Efficacy and Safety of Preoperative IOP Reduction better for Preservative-free Fixed Combination of Dorzolamide/timolol Eye Drops versus Oral Acetazolamide and Dexamethasone Eye Drops for Outcome of Trabeculectomy
Author Affiliations & Notes
  • Katrin Lorenz
    Ophthalmology, University Medical Center Mainz, Mainz, Germany
  • Joanna Wasielica-Poslednik
    Ophthalmology, University Medical Center Mainz, Mainz, Germany
  • Katharina Bell
    Ophthalmology, University Medical Center Mainz, Mainz, Germany
  • Guilia Renieri
    University Eye Clinic, Otto-von-Guericke University Magdeburg, Magdeburg, Germany
    Ophthalmology, University Medical Center Mainz, Mainz, Germany
  • Alexander Keicher
    Ophthalmology, University Medical Center Mainz, Mainz, Germany
    Augenärzte im Basteicenter, Ulm, Germany
  • Christian Ruckes
    Interdisciplinary Center Clinical Trials Mainz, University Medical Center Mainz, Mainz, Germany
  • Norbert Pfeiffer
    Ophthalmology, University Medical Center Mainz, Mainz, Germany
  • Hagen Thieme
    University Eye Clinic, Otto-von-Guericke University Magdeburg, Magdeburg, Germany
    Ophthalmology, University Medical Center Mainz, Mainz, Germany
  • Footnotes
    Commercial Relationships   Katrin Lorenz, None; Joanna Wasielica-Poslednik, None; Katharina Bell, None; Guilia Renieri, None; Alexander Keicher, None; Christian Ruckes, None; Norbert Pfeiffer, None; Hagen Thieme, None
  • Footnotes
    Support  MSD SHARP & DOHME GmbH, Germany and Santen Pharmaceutical Co., Ltd., Japan.
Investigative Ophthalmology & Visual Science June 2017, Vol.58, 2103. doi:
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      Katrin Lorenz, Joanna Wasielica-Poslednik, Katharina Bell, Guilia Renieri, Alexander Keicher, Christian Ruckes, Norbert Pfeiffer, Hagen Thieme; Efficacy and Safety of Preoperative IOP Reduction better for Preservative-free Fixed Combination of Dorzolamide/timolol Eye Drops versus Oral Acetazolamide and Dexamethasone Eye Drops for Outcome of Trabeculectomy. Invest. Ophthalmol. Vis. Sci. 2017;58(8):2103.

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      © ARVO (1962-2015); The Authors (2016-present)

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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.

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