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Published on: January 14, 2020
Binocular treatment of amblyopia using videogames (BRAVO): study protocol for a randomised controlled trial
Cindy X Guo1, Raiju J Babu2, Joanna M Black1
1School of Optometry and Vision Science, The University of Auckland, Auckland, New Zealand.
Insights
This study tested a new videogame treatment for amblyopia in children and adults. The binocular therapy showed promise in improving vision, offering a potential new treatment option for this common visual disorder.
Area of Science:
- Ophthalmology
- Neuroscience
- Vision Science
Background:
- Amblyopia, a common neurodevelopmental vision disorder, causes reduced vision in one eye and impaired binocular function.
- Current treatments, like patching, are primarily for children, with limited options for adults.
- This study addresses the need for effective amblyopia treatments in older individuals.
Purpose of the Study:
- To evaluate the efficacy of a novel binocular, videogame-based treatment for amblyopia in individuals aged 7 years and older.
- To compare the effectiveness of the active binocular treatment against a placebo treatment.
- To investigate improvements in visual acuity and other visual functions.
Main Methods:
- A double-blind, randomized, placebo-controlled multicenter trial (BRAVO study) involving 108 participants.
- Participants aged 7+ with anisometropic and/or strabismic amblyopia received 6 weeks of home-based active or placebo treatment via a modified videogame.
- Outcomes included changes in best-corrected distance visual acuity, stereopsis, and suppression, measured over 24 weeks.
Main Results:
- The primary outcome was the change in amblyopic eye visual acuity from baseline to 6 weeks post-randomization.
- Secondary outcomes assessed improvements in distance/near visual acuity, stereopsis, and strabismus.
- Treatment compliance, acceptability, and quality of life were also evaluated.
Conclusions:
- The BRAVO study is the first RCT of a home-based videogame treatment for older children and adults with amblyopia.
- Results will determine the effectiveness of this binocular approach for patients aged 7 years and older.
- This research may lead to new treatment paradigms for amblyopia in a wider age range.
Background:
Amblyopia is a common neurodevelopmental disorder of vision that is characterised by visual impairment in one eye and compromised binocular visual function. Existing evidence-based treatments for children include patching the nonamblyopic eye to encourage use of the amblyopic eye. Currently there are no widely accepted treatments available for adults with amblyopia. The aim of this trial is to assess the efficacy of a new binocular, videogame-based treatment for amblyopia in older children and adults. We hypothesise that binocular treatment will significantly improve amblyopic eye visual acuity relative to placebo treatment.
Methods/Design:
The BRAVO study is a double-blind, randomised, placebo-controlled multicentre trial to assess the effectiveness of a novel videogame-based binocular treatment for amblyopia. One hundred and eight participants aged 7 years or older with anisometropic and/or strabismic amblyopia (defined as ≥0.2 LogMAR interocular visual acuity difference, ≥0.3 LogMAR amblyopic eye visual acuity and no ocular disease) will be recruited via ophthalmologists, optometrists, clinical record searches and public advertisements at five sites in New Zealand, Canada, Hong Kong and Australia. Eligible participants will be randomised by computer in a 1:1 ratio, with stratification by age group: 7-12, 13-17 and 18 years and older. Participants will be randomised to receive 6 weeks of active or placebo home-based binocular treatment. Treatment will be in the form of a modified interactive falling-blocks game, implemented on a 5th generation iPod touch device viewed through red/green anaglyphic glasses. Participants and those assessing outcomes will be blinded to group assignment. The primary outcome is the change in best-corrected distance visual acuity in the amblyopic eye from baseline to 6 weeks post randomisation. Secondary outcomes include distance and near visual acuity, stereopsis, interocular suppression, angle of strabismus (where applicable) measured at baseline, 3, 6, 12 and 24 weeks post randomisation. Treatment compliance and acceptability will also be assessed along with quality of life for adult participants.
Discussion:
The BRAVO study is the first randomised controlled trial of a home-based videogame treatment for older children and adults with amblyopia. The results will indicate whether a binocular approach to amblyopia treatment conducted at home is effective for patients aged 7 years or older.
Trial Registration:
This trial was registered in Australia and New Zealand Clinical Trials Registry ( ACTRN12613001004752 ) on 10 September 2013.
