Virtual Reality for Enhancement of Vision

NCT07071129 | Terminated Results FDA Device

• 1 other identifier: 39418
• Study Type: interventional
• Target: 22
• Locations: 1 country
• Sites: 1

Brief Summary

This project aims to evaluate the use of Virtual Reality (VR) based visual stimulation for the treatment of blindness arising from Glaucoma and other retinal diseases or disorders of the visual system, through regeneration of axons of retinal ganglion cells (RGCs) in humans. In certain cases of blindness, such as in Glaucoma, or in certain injuries, the optic nerves behind the retina of our eyes get damaged, leading to partial blindness, mostly near the periphery of our eye. Recent research in Dr.Huberman's laboratory has identified visual stimulation as a non-invasive model for regeneration of such damaged axons in rodents, back to the vision centers of their brain.

Conditions

Glaucoma; Vision Disorder

Outcome Measures

Primary Outcomes (2)

• Change in Visual Field Index (VFI)

  VFI (expressed as a percentage) is a global measure of the visual field used to quantify the extent of visual field loss, with 100% representing a normal visual field and 0% indicating complete blindness.

  Baseline, Month 9, Month 24

• Change in Mean Deviation Index (MD)

  MD is a global measure of the visual field. It is a statistical index that represents the average difference in visual field sensitivity compared to a normal age-matched population. It provides an overall measure of visual field loss in decibels, with more negative values indicating greater loss. Normal vision MD is better than -2dB, with end-stage glaucoma represented by a value of less than -20dB.

  Baseline, Month 9, Month 24

Secondary Outcomes (2)

• Retinal Layer Thickness Assessed by Optical Coherence Tomography (OCT)

  baseline and month 9

• Change in Best Corrected Visual Acuity

  baseline and month 9

Other Outcomes (1)

• Change in Pointwise Linear Regression (PLR) Index

  baseline and 2 years

Study Arms (2)

Virtual Reality Stimulation in Patients with Eye Disorders

EXPERIMENTAL

Participants use the VR headset for up to 1 year, followed by 1 year follow-up period.

Device: Virtual Reality Stimulation

Virtual Reality Stimulation in Participants with Normal Vision

EXPERIMENTAL

Participants use the VR headset for up to 1 year, followed by 1 year follow-up period.

Device: Virtual Reality Stimulation

Interventions

Virtual Reality Stimulation DEVICE

VR 1 hour sessions will consist of an exposure to a non-invasive visual stimulation where the subject will be sitting wearing a VR headset.

Virtual Reality Stimulation in Participants with Normal Vision; Virtual Reality Stimulation in Patients with Eye Disorders

Eligibility Criteria

• Age: 12 Years+
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Child (0-17), Adult (18-64), Older Adult (65+)

You may qualify if:

• For subjects with glaucoma, other retinal diseases, or disorders of the visual system:
• \. Patient age \> 12 years
• \. Compliance with investigator instructions, tests and visit during subject participation in the study.
• \. Sufficient fixation ability
• Best corrected visual acuity of 20/200 or better in at least one eye, or capable to see the visual stimulus at least in one eye.
• For healthy volunteers:
• \. Patient age \> 12 years
• \. Compliance with investigator instructions, tests and visit during subject participation in the study.
• Best corrected visual acuity of 20/20 in both eyes.
• \. Sufficient fixation ability

You may not qualify if:

• \. Electric or electronic implants (such as cardiac pacemaker)
• \. Any metal artifacts in the head or truncus area (with the exception of dental implants)
• \. Epilepsy and photo-sensibility; acute auto-immune diseases
• \. Acute conjunctivitis
• \. Pathological nystagmus

Sponsors & Collaborators

• Stanford University: lead

Study Sites (1)

Byers Eye Institute at Stanford University

Palo Alto, California, 94303, United States

Location

MeSH Terms

Conditions

Glaucoma; Vision Disorders

Condition Hierarchy (Ancestors)

Ocular Hypertension; Eye Diseases; Sensation Disorders; Neurologic Manifestations; Nervous System Diseases; Signs and Symptoms; Pathological Conditions, Signs and Symptoms

Limitations and Caveats

Early termination led to a small number of participants analyzed.

Results Point of Contact

• Title: Jeffrey Goldberg, MD, PhD
• Organization: Stanford University

eye-chair-office@stanford.edu

(650) 723-6137

Study Officials

• Jeffrey L Goldberg, MD, PhD

  Stanford University

  PRINCIPAL INVESTIGATOR

Publication Agreements

• PI is Sponsor Employee: Yes

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: NON RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Principal Investigator

Study Record Dates

• First Submitted: July 9, 2025
• First Posted: July 17, 2025
• Study Start: April 17, 2018
• Primary Completion: July 7, 2025
• Study Completion: September 7, 2025
• Last Updated: December 10, 2025
• Results First Posted: December 10, 2025

Record last verified: 2025-11

Data Sharing

• IPD Sharing: Will not share

Locations

US (1)