Tina Y Gao1, Nicola Anstice1, Raiju J Babu2, Joanna M Black1, William R Bobier2, Shuan Dai3, Cindy X Guo1, Robert F Hess4, Michelle Jenkins5, Yannan Jiang5, Lisa Kearns6,7, Lionel Kowal6,7, Carly S Y Lam8, Peter C K Pang8, Varsha Parag5, Jayshree South1, Sandra Elfride Staffieri6,7, Angela Wadham5, Natalie Walker5, Benjamin Thompson1,2. 1. School of Optometry and Vision Science, The University of Auckland, Auckland, New Zealand. 2. School of Optometry and Vision Science, University of Waterloo, Waterloo, Ontario, Canada. 3. Department of Ophthalmology, Auckland City Hospital and Starship Children's Hospital, Auckland, New Zealand. 4. Department of Ophthalmology, McGill Vision Research, McGill University, Montreal, Quebec, Canada. 5. National Institute for Health Innovation, School of Population Health, The University of Auckland, Auckland, New Zealand. 6. Centre for Eye Research Australia, Royal Victorian Eye and Ear Hospital, Melbourne, Victoria, Australia. 7. Ophthalmology, Department of Surgery, University of Melbourne, Melbourne, Victoria, Australia. 8. School of Optometry, The Hong Kong Polytechnic University, Hong Kong, China.
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.
RCT Entities:
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.
Authors: Tina Y Gao; Cindy X Guo; Raiju J Babu; Joanna M Black; William R Bobier; Arijit Chakraborty; Shuan Dai; Robert F Hess; Michelle Jenkins; Yannan Jiang; Lisa S Kearns; Lionel Kowal; Carly S Y Lam; Peter C K Pang; Varsha Parag; Roberto Pieri; Rajkumar Nallour Raveendren; Jayshree South; Sandra Elfride Staffieri; Angela Wadham; Natalie Walker; Benjamin Thompson Journal: JAMA Ophthalmol Date: 2018-02-01 Impact factor: 7.389
Authors: Ruth E Manny; Jonathan M Holmes; Raymond T Kraker; Zhuokai Li; Amy L Waters; Krista R Kelly; Lingkun Kong; Earl R Crouch; Ingryd J Lorenzana; Maan S Alkharashi; Jennifer A Galvin; Melissa L Rice; B Michele Melia; Susan A Cotter Journal: Optom Vis Sci Date: 2022-03-01 Impact factor: 1.973
Authors: Henri J Huttunen; J Matias Palva; Laura Lindberg; Satu Palva; Ville Saarela; Elina Karvonen; Marja-Leena Latvala; Johanna Liinamaa; Sigrid Booms; Eero Castrén; Hannu Uusitalo Journal: Sci Rep Date: 2018-08-27 Impact factor: 4.379