Article Text
Abstract
Background Traditional treatment of amblyopia involves either wearing a patch or atropine penalisation of the better eye. A new treatment is being developed on the basis of virtual reality technology allowing either DVD footage or computer games which present a common background to both eyes and the foreground, containing the imagery of interest, only to the amblyopic eye.
Methods A randomised control trial was performed on patients with amblyopia aged 4–8 years with three arms. All three arms had dichoptic stimulation using shutter glass technology. One arm had DVD footage shown to the amblyopic eye and common background to both, the second used a modified shooter game, Nux, with sprite and targets presented to the amblyopic eye (and background to both) while the third arm had both background and foreground presented to both eyes (non-interactive binocular treatment (non-I-BiT) games).
Results Seventy-five patients were randomised; 67 were residual amblyopes and 70 had an associated strabismus. The visual acuity improved in all three arms by approximately 0.07 logMAR in the amblyopic eye at 6 weeks. There was no difference between I-BiT DVD and non-I-BiT games compared with I-BiT games (stated primary outcome) in terms of gain in vision.
Conclusions There was a modest vision improvement in all three arms. Treatment was well tolerated and safe. There was no difference between the three treatments in terms of primary stated outcomes but treatment duration was short and the high proportion of previously treated amblyopia and strabismic amblyopia disadvantaged dichoptic stimulation treatment.
Trial registration number NCT01702727, results.
- Child health (paediatrics)
- Treatment other
- Vision
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Footnotes
*Previous address, now retired.
Contributors RMG was the principal investigator who conceived and designed the study. He retired prior to commencement of this trial and AJEF took over as chief investigator and principal investigator for the Nottingham site and oversaw delivery. AV was the principal investigator for the Cambridge site. NH was project manager and research orthoptist at the Nottingham site. DMK was research orthoptist at both the Nottingham and Cambridge site. JP had responsibility for the programming. SVC and RME helped both design and maintain the equipment. AF was the trial statistician and undertook the analyses. SMH was a member of the project steering group. This manuscript was drafted by AJEF, revised by AV and approved by all living authors.
Funding The work in this study was funded by the Wellcome Trust (Translation Award 090465).
Competing interests AJEF reports that Nottingham University Hospitals Trust and Nottingham University own the rights to an European patent EP 1 509 121 B1. My coauthors include IMA, SVC, RME, RMG and SMH who are included in the list of inventors.
Ethics approval Nottingham Research Ethics Committee 2.
Provenance and peer review Not commissioned; externally peer reviewed.
Data sharing statement Unpublished data are available upon request.
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