Virtual Reality for Enhancement of Vision

NCT ID: NCT07071129

Last Updated: 2025-12-10

Study Results

Results available

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Basic Information

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Recruitment Status

TERMINATED

Clinical Phase

NA

Total Enrollment

22 participants

Study Classification

INTERVENTIONAL

Study Start Date

2018-04-17

Study Completion Date

2025-09-07

Brief Summary

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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

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Conditions

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Glaucoma Vision Disorder

Study Design

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Allocation Method

NON_RANDOMIZED

Intervention Model

SINGLE_GROUP

Primary Study Purpose

TREATMENT

Blinding Strategy

NONE

Study Groups

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Virtual Reality Stimulation in Patients with Eye Disorders

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

Group Type EXPERIMENTAL

Virtual Reality Stimulation

Intervention Type 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

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

Group Type EXPERIMENTAL

Virtual Reality Stimulation

Intervention Type 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.

Interventions

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Virtual Reality Stimulation

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.

Intervention Type DEVICE

Eligibility Criteria

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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
Minimum Eligible Age

12 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

Yes

Sponsors

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Stanford University

OTHER

Sponsor Role lead

Responsible Party

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Jeffrey L Goldberg

Principal Investigator

Responsibility Role PRINCIPAL_INVESTIGATOR

Principal Investigators

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Jeffrey L Goldberg, MD, PhD

Role: PRINCIPAL_INVESTIGATOR

Stanford University

Locations

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Byers Eye Institute at Stanford University

Palo Alto, California, United States

Site Status

Countries

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United States

Provided Documents

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Document Type: Study Protocol

View Document

Other Identifiers

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39418

Identifier Type: -

Identifier Source: org_study_id

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