Virtual reality stimulation for neuroprotection and neuroenhancement of vision in optic neuropathy patients: a prospective clinical trial
摘要
This study aimed to assess the safety and efficacy of virtual reality (VR) visual stimulation on neuroprotection and neuroenhancement in optic neuropathy patients.
MethodsOpen-label, prospective, phase I clinical trial, enrolling 21 participants with glaucoma, plus 1 patient with ischemic optic neuropathy after hydrocephalus. Participants received commercially available VR headsets (HTC Vive or Oculus Rift) for home use loaded with a study-specific visual stimulus program. The VR visual stimulation protocol consisted of up to 1-hour daily sessions, 5 days per week, for 12-week cycles repeatable for up to 24 months. Safety was assessed through adverse event monitoring, and compliance was assessed through self-report. Testing of function (visual acuity and visual field) and structure (optical coherence tomography (OCT) for retinal nerve fiber layer (RNFL) and ganglion cell complex (GCC) thickness) were measured at baseline and follow-up.
ResultsVR-based visual stimulation was safe and well tolerated across the 22-patient cohort. Mean baseline intraocular pressure (IOP) was 12.06 ± 0.76 mmHg and there was no significant change in IOP at follow-up. 8 of 22 patients were sufficiently compliant with use to analyze for efficacy measures. Analysis of Humphrey visual field (HVF) mean deviation (MD) of individual patients revealed that two eyes of two patients showed improvement and seven eyes of five patients showed worsening during the study duration. One patient using Goldmann visual fields (GVF) demonstrated improvement in sensitivity in both eyes. There were no statistically significant changes in visual acuity, HVF MD, GCC thickness, or RNFL thickness across the full patient population. Two illustrative cases were selected to demonstrate the potential therapeutic effects of VR visual stimulation.
ConclusionThese findings demonstrate that VR-based visual stimulation is safe, well-tolerated, and may provide functional benefits in selected patients. Additional studies are warranted to further investigate this therapeutic approach.
Trial registrationClinicalTrials.gov, TRN: NCT07071129, Registration date: 9 July 2025, retrospectively registered.