Virtual Reality for Enhancement of Vision

Not Applicable

Terminated

• Conditions: Glaucoma; Vision Disorder

• Registration Number: NCT07071129
• Lead Sponsor: Stanford University

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.

Detailed Description

Not available

Study Timeline

• Study Start: 2018-04-17
• Primary Completion: 2022-07-07
• Study Completion: 2022-07-07
• Status Verified: 2025-07
• Study First Submitted: 2025-07-09
• Study First Submitted QC: 2025-07-09
• Last Update Submitted: 2025-07-09
• Study First Posted: 2025-07-17
• Last Update Posted: 2025-07-17

Recruitment & Eligibility

• Status: TERMINATED
• Sex: All
• Target Recruitment: 22

Inclusion Criteria

For subjects with glaucoma, other retinal diseases, or disorders of the visual system:

• 1. Patient age > 12 years
• 2. Compliance with investigator instructions, tests and visit during subject participation in the study.
• 3. Sufficient fixation ability
• 4.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:

• 1. Patient age > 12 years
• 2. Compliance with investigator instructions, tests and visit during subject participation in the study.
• 3.Best corrected visual acuity of 20/20 in both eyes.
• 4. Sufficient fixation ability

Exclusion Criteria

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

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: SINGLE_GROUP

Primary Outcome Measures

Name	Time	Method
Change in Mean Deviation Index (MD)	baseline and 2 years	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.
Change in Visual Field Index (VFI)	baseline and 2 years	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.

Secondary Outcome Measures

Name	Time	Method
Change in Retinal Layer Thickness assessed by Optical Coherence Tomography (OCT)	baseline and 2 years	OCT is a non-invasive imaging technique that uses light waves to create detailed, cross-sectional images of the eye, and is used to diagnose and manage various eye conditions.
Change in Best Corrected Visual Acuity	baseline and 2 years

Trial Locations

Locations (1)

Byers Eye Institute at Stanford University; 🇺🇸 Palo Alto, California, United States