Digital Defocus Vision Training (DDVT) Using Virtual Reality for Myopia Control A Randomized Clinical Trial

ABSTRACTSIMPORTANCE Early control of myopia progression in childhood is critical to reduce the risk of developing high myopia and its associated sight-threatening complications. Virtual reality–based digital defocus visual training (DDVT) may provide a novel, home-based strategy to slow ocular growth.OBJECTIVE To evaluate the efficacy and safety of a head-mounted virtual reality–based DDVT system in controlling myopia progression in children.DESIGN, SETTING, AND PARTICIPANTS This monocentric, randomized, parallel-group, single-blind clinical trial enrolled 120 children aged 6 to 12 years in July 2024. Eligible participants had cycloplegic spherical equivalent refraction (SER) between −0.75 and −6.00 diopters (D), astigmatism of 2.50 D or less, anisometropia of 1.00 D or less, and best-corrected visual acuity (BCVA) of 0.1 logMAR or better. Follow-up was completed in September 2025.INTERVENTION Participants were randomly assigned to receive DDVT plus single-vision spectacles (SVS) or SVS alone. The DDVT program was delivered through a head-mounted virtual reality device and performed at home for 15 minutes nightly under parental supervision after an initial in-hospital training session.MAIN OUTCOMES AND MEASURES The primary outcome was the between-group difference in axial length (AL) change from baseline to 6 months. The key secondary outcome was the between-group difference in SER change. Additional secondary outcomes included choroidal blood flow, accommodative facility (AF), positive and negative relative accommodation (PRA and NRA), intraocular pressure (IOP), BCVA, and visual fatigue score.RESULTS Of 120 randomized participants, 116 (96.7%) completed the study and were included in the analysis (57 in the DDVT group and 59 in the SVS group). The DDVT group demonstrated significant improvements in accommodative function (NRA, PRA, and AF; all P < .05), decreased IOP (P < .05), reduced visual fatigue (P < .05), and increased choroidal blood flow (P < .05). At 6 months, mean (SD) AL and SER changes were 0.147 (0.095) mm and −0.230 (0.269) D in the DDVT group, compared with 0.254 (0.109) mm and −0.460 (0.387) D in the SVS group. Between-group differences in AL and SER were statistically significant (both P < .05). No training-related adverse events were reported.CONCLUSIONS AND RELEVANCE Virtual reality–based digital defocus vision training was safe and was associated with improved accommodative function and slower myopia progression in children, with good treatment adherence, suggesting that it may represent a promising adjunctive approach for pediatric myopia control. The raw data and figures of study