title: 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.
abstract: BACKGROUND
  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.
  
  
  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.
  
  
  CONCLUSIONS
  Preoperative, preservative-free, fixed-dose dorzolamide/timolol seems to be equally effective as preoperative acetazolamide and dexamethasone and has a favourable safety profile.
authors.affiliation: Department of Ophthalmology, University Medical Center, Johannes Gutenberg-University Mainz, Mainz, Germany.
authors.forename: Katrin
authors.initials: K
authors.lastname: Lorenz
authors.affiliation: Department of Ophthalmology, University Medical Center, Johannes Gutenberg-University Mainz, Mainz, Germany.
authors.forename: Joanna
authors.initials: J
authors.lastname: Wasielica-Poslednik
authors.affiliation: Department of Ophthalmology, University Medical Center, Johannes Gutenberg-University Mainz, Mainz, Germany.
authors.forename: Katharina
authors.initials: K
authors.lastname: Bell
authors.affiliation: Department of Ophthalmology, University Medical Center, Johannes Gutenberg-University Mainz, Mainz, Germany.|University Eye Clinic, Otto-von-Guericke University Magdeburg, Magdeburg, Germany.
authors.forename: Giulia
authors.initials: G
authors.lastname: Renieri
authors.affiliation: Department of Ophthalmology, University Medical Center, Johannes Gutenberg-University Mainz, Mainz, Germany.|Augenärzte im Basteicenter, Ulm, Germany.
authors.forename: Alexander
authors.initials: A
authors.lastname: Keicher
authors.affiliation: Interdisciplinary Center Clinical Trials Mainz, University Medical Center, Johannes Gutenberg-University Mainz, Mainz, Germany.
authors.forename: Christian
authors.initials: C
authors.lastname: Ruckes
authors.affiliation: Department of Ophthalmology, University Medical Center, Johannes Gutenberg-University Mainz, Mainz, Germany.
authors.forename: Norbert
authors.initials: N
authors.lastname: Pfeiffer
authors.affiliation: Department of Ophthalmology, University Medical Center, Johannes Gutenberg-University Mainz, Mainz, Germany.|University Eye Clinic, Otto-von-Guericke University Magdeburg, Magdeburg, Germany.
authors.forename: Hagen
authors.initials: H
authors.lastname: Thieme
mesh_terms: D000086:Acetazolamide / Q000008:administration & dosage* / Q000494:pharmacology; D000368:Aged; D000959:Antihypertensive Agents / Q000627:therapeutic use; D003907:Dexamethasone / Q000008:administration & dosage* / Q000494:pharmacology; D004338:Drug Combinations; D005260:Female; D005472:Fluorouracil / Q000627:therapeutic use; D005901:Glaucoma / Q000188:drug therapy* / Q000473:pathology / Q000601:surgery; D006801:Humans; D007429:Intraocular Pressure / Q000187:drug effects; D008297:Male; D008875:Middle Aged; D009798:Ocular Hypertension / Q000188:drug therapy; D009883:Ophthalmic Solutions / Q000008:administration & dosage* / Q000494:pharmacology; D011300:Preoperative Care; D011446:Prospective Studies; D013449:Sulfonamides / Q000008:administration & dosage* / Q000494:pharmacology; D013876:Thiophenes / Q000008:administration & dosage* / Q000494:pharmacology; D013999:Timolol / Q000008:administration & dosage* / Q000494:pharmacology; D014130:Trabeculectomy; D016896:Treatment Outcome
chemical_list: D000959:Antihypertensive Agents; D004338:Drug Combinations; D009883:Ophthalmic Solutions; D013449:Sulfonamides; D013876:Thiophenes; C479140:dorzolamide-timolol combination; D003907:Dexamethasone; D013999:Timolol; D000086:Acetazolamide; D005472:Fluorouracil