title: The United Kingdom Glaucoma Treatment Study: a multicenter, randomized, double-masked, placebo-controlled trial: baseline characteristics.
abstract: OBJECTIVE
  The United Kingdom Glaucoma Treatment Study (UKGTS) tests the hypothesis that treatment with a topical prostaglandin analog, compared with placebo, reduces the frequency of visual field (VF) deterioration events in patients with open-angle glaucoma (OAG) by 50% over a 2-year period. Additional goals are to evaluate study power with novel clinical trial outcomes: (1) VF deterioration velocity and (2) VF and quantitative imaging measurements modeled as joint outcomes.
  
  
  METHODS
  The UKGTS is a randomized, double-masked, placebo-controlled, multicenter treatment trial for OAG.
  
  
  METHODS
  A total of 516 patients with newly diagnosed (previously untreated) OAG were prospectively recruited at 10 UK centers between 2007 and 2010.
  
  
  METHODS
  Eligible patients were randomly assigned to treatment with latanoprost 0.005% or placebo. The observation period was 2 years, with subjects monitored by VF testing, quantitative imaging, optic disc photography, and tonometry at 11 visits.
  
  
  METHODS
  The primary outcome measure is time to VF deterioration within 24 months. Secondary outcomes include the deterioration velocity of VF and quantitative imaging measures.
  
  
  RESULTS
  The main source of referrals was optometrists (88%). A total of 777 subjects were assessed for eligibility, and 261 were excluded because they did not meet the inclusion criteria or declined to participate. The mean age of the 516 participants was 66 years, and 52.9% were male; 90.1% of the participants were white, and approximately one third (32.2%) reported a family history of glaucoma. A total of 777 eyes were eligible at initial assessment. Both eyes were eligible for 265 participants. Mean (standard deviation) intraocular pressure (IOP) at baseline for the eyes with better versus worse mean deviation (MD) was 18.9 (4.1) and 19.9 (4.7) mmHg, respectively (P = 0.0053). Some 56.1% of all eligible eyes had IOP <20 mmHg at baseline. The median (interquartile range) VF MD for all eligible eyes was -2.9 dB (-1.6 to -4.8 dB).
  
  
  CONCLUSIONS
  This is the first randomized, placebo-controlled trial to evaluate the efficacy of medical treatment in reducing VF deterioration in OAG. The baseline characteristics for eligible patients and eyes from this cohort are presented and compared with those of previous trials. The baseline characteristics are similar to those of the largely population-based Early Manifest Glaucoma Trial. The early stage of the glaucoma and relatively low IOP at diagnosis suggest remarkably sensitive case findings by community optometrists in the United Kingdom.
authors.affiliation: National Institute for Health Research Biomedical Research Centre at Moorfields Eye Hospital NHS Foundation Trust and UCL Institute of Ophthalmology, London, United Kingdom.
authors.forename: Gerassimos
authors.initials: G
authors.lastname: Lascaratos
authors.affiliation: National Institute for Health Research Biomedical Research Centre at Moorfields Eye Hospital NHS Foundation Trust and UCL Institute of Ophthalmology, London, United Kingdom. Electronic address: david.garway-heath@moorfields.nhs.uk.
authors.forename: David F
authors.initials: DF
authors.lastname: Garway-Heath
authors.affiliation: Department of Optometry and Visual Science, City University London, United Kingdom.
authors.forename: Robyn
authors.initials: R
authors.lastname: Burton
authors.affiliation: National Institute for Health Research Biomedical Research Centre at Moorfields Eye Hospital NHS Foundation Trust and UCL Institute of Ophthalmology, London, United Kingdom.
authors.forename: Catey
authors.initials: C
authors.lastname: Bunce
authors.affiliation: Department of Optometry and Visual Science, City University London, United Kingdom.
authors.forename: Wen
authors.initials: W
authors.lastname: Xing
authors.affiliation: Department of Optometry and Visual Science, City University London, United Kingdom.
authors.forename: David P
authors.initials: DP
authors.lastname: Crabb
authors.affiliation: National Institute for Health Research Biomedical Research Centre at Moorfields Eye Hospital NHS Foundation Trust and UCL Institute of Ophthalmology, London, United Kingdom; Department of Optometry and Visual Science, City University London, United Kingdom.
authors.forename: Richard A
authors.initials: RA
authors.lastname: Russell
authors.affiliation: National Institute for Health Research Biomedical Research Centre at Moorfields Eye Hospital NHS Foundation Trust and UCL Institute of Ophthalmology, London, United Kingdom.
authors.forename: Ameet
authors.initials: A
authors.lastname: Shah
mesh_terms: D000328:Adult; D000368:Aged; D000959:Antihypertensive Agents / Q000627:therapeutic use*; D004311:Double-Blind Method; D005260:Female; D005902:Glaucoma, Open-Angle / Q000188:drug therapy* / Q000503:physiopathology; D006068:Gonioscopy; D006801:Humans; D007429:Intraocular Pressure / Q000187:drug effects*; D000077338:Latanoprost; D008297:Male; D008875:Middle Aged; D011446:Prospective Studies; D011461:Prostaglandins F, Synthetic / Q000627:therapeutic use*; D041623:Tomography, Optical Coherence; D014065:Tonometry, Ocular; D016896:Treatment Outcome; D006113:United Kingdom; D014786:Vision Disorders / Q000188:drug therapy / Q000503:physiopathology; D014792:Visual Acuity / Q000502:physiology; D014794:Visual Fields / Q000187:drug effects / Q000502:physiology; D055815:Young Adult
chemical_list: D000959:Antihypertensive Agents; D011461:Prostaglandins F, Synthetic; D000077338:Latanoprost