NEIVATECH pilot study: immersive virtual reality training in older amblyopic children with non-compliance or non-response to patching.

Immersive virtual reality (VR) is recently being explored as a therapeutic alternative for the treatment of amblyopia. This pilot study aimed to evaluate the preliminary efficacy, safety, usability and satisfaction obtained with the use of a novel VR system (NEIVATECH) to provide binocular vision training in previously treated older amblyopic children with non-compliance or non-response to patching. A prospective, multicentre, open-label, single-arm, pilot study was conducted in which the intervention under study was 9 h of therapy with the NEIVATECH system, distributed in 18 half-hour sessions spread over 1 month. A comprehensive visual assessment was conducted before and after the intervention, and at the end of the intervention the safety and usability of the system and patient satisfaction were evaluated. After therapy, statistically significant differences were observed in the near best-corrected visual acuity (BCVA) of the dominant (p = 0.022) and non-dominant (p = 0.022) eye, in stereopsis based on the Binocular Function Score (p = 0.045) and in the break (p = 0.012) and recovery (p = 0.009) points of negative fusional vergence for distance vision. The safety and usability of the system and patient satisfaction with the therapy were adequate. These findings support further investigation of this treatment option in future studies incorporating a control group with which to compare the results obtained. Trial registration: NCT04819386.