@article{7ba3d8a99f1b458d84931776e7f79659,
title = "Optical treatment of amblyopia in older children and adults is essential prior to enrolment in a clinical trial",
abstract = "Purpose: Optical treatment alone can improve visual acuity (VA) in children with amblyopia, thus clinical trials investigating additional amblyopia therapies (such as patching or videogames) for children require a preceding optical treatment phase. Emerging therapies for adult patients are entering clinical trials. It is unknown whether optical treatment is effective for adults with amblyopia and whether an optical correction phase is required for trials involving adults. Methods: We examined participants who underwent optical treatment in the Binocular Treatment for Amblyopia using Videogames (BRAVO) clinical trial (ANZCTR ID: ACTRN12613001004752). Participants were recruited in three age groups (7 to 12, 13 to 17, or ≥18 years), and had unilateral amblyopia due to anisometropia and/or strabismus, with amblyopic eye VA of 0.30–1.00 logMAR (6/12 to 6/60, 20/40 to 20/200). Corrective lenses were prescribed based on cycloplegic refraction to fully correct any anisometropia. VA was assessed using the electronic visual acuity testing algorithm (e-ETDRS) test and near stereoacuity was assessed using the Randot Preschool Test. Participants were assessed every four weeks up to 16 weeks, until either VA was stable or until amblyopic eye VA improved to better than 0.30 logMAR, rendering the participant ineligible for the trial. Results: Eighty participants (mean age 24.6 years, range 7.6–55.5 years) completed four to 16 weeks of optical treatment. A small but statistically significant mean improvement in amblyopic eye VA of 0.05 logMAR was observed (S.D. 0.08 logMAR; paired t-test p < 0.0001). Twenty-five participants (31%) improved by ≥1 logMAR line and of these, seven (9%) improved by ≥2 logMAR lines. Stereoacuity improved in 15 participants (19%). Visual improvements were not associated with age, presence of strabismus, or prior occlusion treatment. Two adult participants withdrew due to intolerance to anisometropic correction. Sixteen out of 80 participants (20%) achieved better than 0.30 logMAR VA in the amblyopic eye after optical treatment. Nine of these participants attended additional follow-up and four (44%) showed further VA improvements. Conclusions: Improvements from optical treatment resulted in one-fifth of participants becoming ineligible for the main clinical trial. Studies investigating additional amblyopia therapies must include an appropriate optical treatment only phase and/or parallel treatment group regardless of patient age. Optical treatment of amblyopia in adult patients warrants further investigation.",
keywords = "adults, amblyopia, children, optical treatment, refractive adaptation, Double-Blind Method, Follow-Up Studies, Sensory Deprivation, Humans, Middle Aged, Male, Treatment Outcome, Visual Acuity/physiology, Eyeglasses, Young Adult, Amblyopia/physiopathology, Adolescent, Adult, Female, Child",
author = "{the Binocular Treatment of Amblyopia Using Videogames (BRAVO) Study Team} and Gao, {Tina Y.} and Nicola Anstice and Babu, {Raiju J.} and Black, {Joanna M.} and Bobier, {William R.} and Shuan Dai and Guo, {Cindy X.} and Hess, {Robert F.} and Michelle Jenkins and Yannan Jiang and Lisa Kearns and Lionel Kowal and Lam, {Carly S.Y.} and Pang, {Peter C.K.} and Varsha Parag and Jayshree South and Staffieri, {Sandra Elfride} and Angela Wadham and Natalie Walker and Benjamin Thompson",
note = "Funding Information: The BRAVO study was supported by projects grant from the Health Research Council of New Zealand (reference 13/ 169) and the Hong Kong Health and Medical Research Fund (reference 11122991). The Centre for Eye Research Australia receives Operational Infrastructure Support from the Victorian Government. Author Tina Y. Gao received doctoral scholarship support from the New Zealand Association of Optometrists during this study. Funding Information: The BRAVO study was supported by projects grant from the Health Research Council of New Zealand (reference 13/169) and the Hong Kong Health and Medical Research Fund (reference 11122991). The Centre for Eye Research Australia receives Operational Infrastructure Support from the Victorian Government. Author Tina Y. Gao received doctoral scholarship support from the New Zealand Association of Optometrists during this study. The funding bodies had no role in the design of this study, data collection, analysis or interpretation, or the writing of the manuscript. Additional members of the BRAVO clinical trial team: Taina Von Blaramberg (University of Auckland), Stephen J Boswell (University of Auckland), Arijit Chakraborty (University of Waterloo), Lily Chan (The Hong Kong Polytechnic University), Geoffrey Chu (The Hong Kong Polytechnic University), Simon Clavagnier (McGill University), Ka Ching Ho (The Hong Kong Polytechnic University), Colin Howe (University of Auckland), Michelle Jenkins (University of Auckland), Joanna Michie (University of Auckland), Colleen Ng (University of Auckland), John Faafetai Faatui (University of Auckland), Roberto Pieri (Private Eye Clinic, Melbourne, Australia), Rajkumar Nallour Raveendren (University of Waterloo), Daniel Spiegel (McGill University), Stuart L Uren (University of Auckland). We would also like to thank all participants and parents/guardians for their time and efforts. Publisher Copyright: {\textcopyright} 2018 The Authors Ophthalmic & Physiological Optics {\textcopyright} 2018 The College of Optometrists",
year = "2018",
month = mar,
day = "1",
doi = "10.1111/opo.12437",
language = "English",
volume = "38",
pages = "129--143",
journal = "Ophthalmic and Physiological Optics",
issn = "0275-5408",
publisher = "Wiley-Blackwell",
number = "2",
}