4 Week’s Report for Virtual Reality on Children Amblyopia Therapy

Purpose: To compare safety and Visual Acuity (VA) improvement in children with amblyopia treated with Virtual Reality (VR) plus spectacle correction and patching versus. spectacle correction and patching only. Design: Multicenter randomized clinical trial. Subjects: Twenty-eight subjects aged 4 to 12 years with amblyopia (20/400 to 20/25) from strabismus, refractive amblyopia, and visual deprivation amblyopia or combined types according to “Consensus of experts in the diagnosis of Amblyopia” in 2011 by Chinese Ophthalmology Society. Subjects were required to have never been treated or stopped treatment of patching over 4 weeks prior to enrollment. Subjects were randomly assigned to either VR games for 0.5 hour a day with patching and spectacles correction (12 subjects; VR group) or patching and spectacles correction (18 subjects; control group). Study follow-up visits were scheduled at 4, 8, and 13 weeks. This paper was only for 4 weeks. Methods: Eligible subjects (mean baseline corrected logMarVA was 0.54±0.28) were randomly assigned to treatment for 4 weeks with the VR binocular therapy (prescribed for 30min per day 3 days per week) plus spectacle correction and patching if needed (n=12) or spectacle correction with patching if needed (n=16). Main outcome measures: Advent event in VR group and change in amblyopic-eye VA from baseline to 4 weeks, assessed by a masked examiner. Results: Safety: All 28 children reported no severe adverse event or device failure rate during 4 weeks of treatment; There was no significant difference between the dropping BCVA of fellow eye between VR group and control group. There were 12 and 16 experimental groups and control groups in baseline group, respectively, 8 and 6 completed complete 4-week treatment and follow-up. Effective: At Week 4, the VR group had a significant improvement in BCVA (logMarVA=0.4±0.35) compared to baseline BCVA (logMarVA=0.575±0.34) (P=0.029, t-test); The BCVA of the relatively good eyes in the experimental group improved but was not significant (logMarVA increased from baseline 0.169 to 0.115); At the baseline, there was no significant difference between the baseline and the control group, with the average BCVA of 0.575 to 0.34, 0.588 to 0.26 (P=0.914), and after 4 weeks of treatment, the VR group had an average BCVA (0.40±0.35, n=6), higher than the control group’s average BCVA (0.525 ± 0.26, n=8), but the difference was not significant (P=0.458). Conclusions: Caterna Virtual Reality was safe with a viable treatment option for the children amblyopia. Combining therapy of VR, spectacles and patching at baseline significantly improved the BCVA at 4 weeks.