Effect of virtual reality-based visual training for myopia control in children: a randomized controlled trial.

ABSTRACT

BACKGROUND: To assess the efficacy and safety of virtual reality-based visual training (VRVT) in myopia control among children. METHODS: The randomized, parallel-group, single-blind clinical trial conducted at the Department of Ophthalmology of Shanghai Tenth People's Hospital enrolled 65 low-myopic children (aged 8 to 13 years) with cycloplegic spherical equivalent (SE) between - 0.50 and - 3.00 diopters (D), astigmatism less than - 1.00 D, anisometropia less than 1.50D, and best corrected visual acuity (BCVA) more than 0.0 logarithm (LogMAR) of the minimum angle of resolution. The participants were enrolled in December 2020, and the follow-up of this study concluded on August 2021. Children were assigned randomly to the intervention group (VRVT plus single-vision spectacle [SVS]) and the control group (only SVS without receiving VRVT). The intervention group was administered for 20 min per day with VRVT under parental supervision at home. The primary outcome was changes in axial length (AL) at 3 months. Macular choroidal thickness (mCT) was regarded as a key secondary outcome. RESULTS: Among 65 participants (mean age 10.8 years, 52.3% male), 60 children (92.3%) who completed the 3-month intervention and 6-month follow-up were included in the analysis (30 in the intervention group and 30 in the control group). The changes of AL were 0.063 ± 0.060 mm (95% confidence interval [CI], 0.074 to 0.119 mm) in the intervention group and 0.129 ± 0.060 mm (95% CI, 0.107 to 0.152 mm) and in the control group at 3 months (t = - 2.135, P = 0.037), and the mean difference between the two groups was 0.066 mm. The change of mCT were 22.633 ± 36.171 µm (95% CI, 9.127 to 36.140 µm) in the intervention group and - 3.000 ± 31.056 µm (95% CI, - 14.597 to 8.597 µm) in the control group at 3 months (t = 2.945, P = 0.005). VR vertigo was the most common adverse event which was occurred in two children (2/30, 6.67%) in the intervention group. CONCLUSIONS: VRVT is a promising method for myopia control in children with good user acceptability. Among children aged 8 to 13 years with low-myopia, nightly use of VRVT resulted in slowing myopia progression. TRIAL REGISTRATION This protocol was registered with ClinicalTrials.gov (NCT06250920), retrospectively registered on 01 February 2024.