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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.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| 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. |
|
| 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. |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| 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. |
|
| Measure | Description | Time Frame |
|---|---|---|
| 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 |
| Measure | Description | Time Frame |
|---|---|---|
| Retinal Layer Thickness Assessed by Optical Coherence Tomography (OCT) | 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. | baseline and month 9 |
| Change in Best Corrected Visual Acuity |
| Measure | Description | Time Frame |
|---|---|---|
| Change in Pointwise Linear Regression (PLR) Index | PLR is a point-specific measure of the visual field. It is a statistical method used to analyze visual field (VF) data, particularly in the context of glaucoma progression, by examining the trend of threshold sensitivity at each test location over time. It estimates the rate of change at each location, providing a detailed view of visual field deterioration. |
Inclusion Criteria:
For subjects with glaucoma, other retinal diseases, or disorders of the visual system:
For healthy volunteers:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Jeffrey L Goldberg, MD, PhD | Stanford University | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Byers Eye Institute at Stanford University | Palo Alto | California | 94303 | United States |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 41422005 | Derived | Healzer KJ, Khatib TZ, Beykin G, Wennberg-Smith Z, Nunez M, Huberman AD, Goldberg JL. Virtual reality stimulation for neuroprotection and neuroenhancement of vision in optic neuropathy patients: a prospective clinical trial. BMC Ophthalmol. 2025 Dec 20;26(1):40. doi: 10.1186/s12886-025-04576-w. |
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| ID | Title | Description |
|---|---|---|
| FG000 | Virtual Reality Stimulation in Patients with Eye Disorders | Participants use the VR headset for up to 2 years, followed by up to 1 year follow-up period. |
| FG001 | Virtual Reality Stimulation in Participants with Normal Vision | Participants use the VR headset for up to 2 years, followed by up to 1 year follow-up period. |
| Title | Milestones | Reasons Not Completed | |||||||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Overall Study |
|
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| ID | Title | Description |
|---|---|---|
| BG000 | Virtual Reality Stimulation in Patients With Eye Disorders | Participants use the VR headset for up to 2 years, followed by up to 1 year follow-up period. |
| Units | Counts |
|---|---|
| Participants |
|
| Title | Description | Population Description | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Denominator Units Selected | Denominators | Classes |
|---|---|---|---|---|---|---|---|---|---|
| Age, Continuous | Median |
| Type | Title | Description | Population Description | Reporting Status | Anticipated Posting Date | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Time Frame | Units Analyzed | Denominator Units Selected | Arm/Group Information | Denominators | Classes | Analyses | ||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Primary | 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. | Participants with data at the respective timepoint | Posted | Mean | Standard Error | Percent of visual field | Baseline, Month 9, Month 24 | Eyes | Eyes |
|
|
Up to 2 years treatment
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| ID | Title | Description | Deaths (Affected) | Deaths (At Risk) | Serious Events (Affected) | Serious Events (At Risk) | Other Events (Affected) | Other Events (At Risk) |
|---|---|---|---|---|---|---|---|---|
| EG000 | Virtual Reality Stimulation in Patients with Eye Disorders | Participants use the VR headset for up to 2 years, followed by up to 1 year follow-up period. |
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| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
|---|---|---|---|---|---|
| Increased TMJ pain | Musculoskeletal and connective tissue disorders | Systematic Assessment |
Early termination led to a small number of participants analyzed.
| Title | Organization | Phone | Extension | |
|---|---|---|---|---|
| Jeffrey Goldberg, MD, PhD | Stanford University | (650) 723-6137 | eye-chair-office@stanford.edu |
| Type | Includes Protocol | Includes SAP | Includes ICF | Document Label | Document Date | Document Uploaded Date | Document File Name |
|---|---|---|---|---|---|---|---|
| Prot | Yes | No | No | Study Protocol | Feb 12, 2020 | Jul 16, 2025 | Prot_000.pdf |
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| ID | Term |
|---|---|
| D005901 | Glaucoma |
| D014786 | Vision Disorders |
| ID | Term |
|---|---|
| D009798 | Ocular Hypertension |
| D005128 | Eye Diseases |
| D012678 | Sensation Disorders |
| D009461 | Neurologic Manifestations |
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Monocular Best Corrected Distance Visual Acuity in logMAR. Visual acuity of 20/20 = 0.00 on the logMAR scale, higher scores indicate worse vision (20/800 is the equivalent of 1.6 logMAR). |
| baseline and month 9 |
| baseline and 2 years |
| years |
|
| Sex: Female, Male | Count of Participants | Participants |
|
| Race (NIH/OMB) | Count of Participants | Participants |
|
| Region of Enrollment | Count of Participants | Participants |
|
| Participants |
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| Eyes |
|
|
| Primary | 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. | Participants with data at the respective timepoint | Posted | Mean | Standard Error | Decibels | Baseline, Month 9, Month 24 | Eyes | Eyes |
|
|
|
| Secondary | Retinal Layer Thickness Assessed by Optical Coherence Tomography (OCT) | 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. | Participants with glaucoma who reliably completed treatment | Posted | Mean | Standard Error | microns | baseline and month 9 |
|
|
|
| Secondary | Change in Best Corrected Visual Acuity | Monocular Best Corrected Distance Visual Acuity in logMAR. Visual acuity of 20/20 = 0.00 on the logMAR scale, higher scores indicate worse vision (20/800 is the equivalent of 1.6 logMAR). | Participants with glaucoma who reliably completed treatment | Posted | Mean | Standard Error | logMAR | baseline and month 9 |
|
|
|
| Other Pre-specified | Change in Pointwise Linear Regression (PLR) Index | PLR is a point-specific measure of the visual field. It is a statistical method used to analyze visual field (VF) data, particularly in the context of glaucoma progression, by examining the trend of threshold sensitivity at each test location over time. It estimates the rate of change at each location, providing a detailed view of visual field deterioration. | Not Posted | baseline and 2 years | Participants |
| 0 |
| 22 |
| 0 |
| 22 |
| 2 |
| 22 |
| Body Aches | Musculoskeletal and connective tissue disorders | Systematic Assessment |
|
| Neurological storm | Nervous system disorders | Systematic Assessment |
|
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| D009422 |
| Nervous System Diseases |
| D012816 | Signs and Symptoms |
| D013568 | Pathological Conditions, Signs and Symptoms |
| Month 9 |
|
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| Month 24 |
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