Clinical trial of beyond contact lenses trial#

While effective, these monocular treatments may result in adverse psychosocial effects and compliance can be low. In children, the visual acuity deficit associated with amblyopia can be treated monocularly by optically correcting any significant refractive error and then occluding (patching) or penalising (with atropine cycloplegia) the fellow eye to encourage use of the amblyopic eye. Stronger interocular suppression has been associated with poorer stereopsis and monocular visual acuity in patients, as well as poorer amblyopic eye contrast sensitivity in animal models of amblyopia. In particular, the fellow eye often suppresses the amblyopic eye when both eyes are open, and stereopsis is commonly impaired or absent. Patients with amblyopia also experience impaired binocular vision. Amblyopia causes a range of monocular deficits in the affected eye including impaired visual acuity, contrast sensitivity, motion perception and excessive crowding (see for a recent review).

Clinical trial of beyond contact lenses trial#

This trial was registered in Australia and New Zealand Clinical Trials Registry ( ACTRN12613001004752) on 10 September 2013.Īmblyopia is a neurodevelopmental disorder of the visual system that is caused by abnormal binocular visual experience during early childhood, typically due to anisometropia or strabismus. The results will indicate whether a binocular approach to amblyopia treatment conducted at home is effective for patients aged 7 years or older. The BRAVO study is the first randomised controlled trial of a home-based videogame treatment for older children and adults with amblyopia. Treatment compliance and acceptability will also be assessed along with quality of life for adult participants. 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. The primary outcome is the change in best-corrected distance visual acuity in the amblyopic eye from baseline to 6 weeks post randomisation. Participants and those assessing outcomes will be blinded to group assignment. 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 will be randomised to receive 6 weeks of active or placebo home-based binocular treatment. 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. 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. 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. We hypothesise that binocular treatment will significantly improve amblyopic eye visual acuity relative to placebo treatment. The aim of this trial is to assess the efficacy of a new binocular, videogame-based treatment for amblyopia in older children and adults. Currently there are no widely accepted treatments available for adults with amblyopia. Existing evidence-based treatments for children include patching the nonamblyopic eye to encourage use of the amblyopic eye. Amblyopia is a common neurodevelopmental disorder of vision that is characterised by visual impairment in one eye and compromised binocular visual function.