Glaucoma, Vision Disorder
Conditions
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.
Interventions
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.
Sponsors
Stanford University
Study design
Allocation
NON_RANDOMIZED
Intervention model
SINGLE_GROUP
Primary purpose
TREATMENT
Masking
NONE
Eligibility
Sex/Gender
ALL
Age
12 Years to No maximum
Healthy volunteers
Yes
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
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Change in Visual Field Index (VFI) | Baseline, Month 9, Month 24 | 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. |
| Change in Mean Deviation Index (MD) | Baseline, Month 9, Month 24 | 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. |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Retinal Layer Thickness Assessed by Optical Coherence Tomography (OCT) | baseline and month 9 | 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 month 9 | 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). |
Other
| Measure | Time frame | Description |
|---|---|---|
| Change in Pointwise Linear Regression (PLR) Index | baseline and 2 years | 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. |
Countries
United States
Participant flow
Participants by arm
| Arm | Count |
|---|---|
| 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. | 22 |
| Total | 22 |
Baseline characteristics
| Characteristic | Virtual Reality Stimulation in Patients With Eye Disorders |
|---|---|
| Age, Continuous | 66.5 years |
| Race (NIH/OMB) American Indian or Alaska Native | 0 Participants |
| Race (NIH/OMB) Asian | 5 Participants |
| Race (NIH/OMB) Black or African American | 1 Participants |
| Race (NIH/OMB) More than one race | 0 Participants |
| Race (NIH/OMB) Native Hawaiian or Other Pacific Islander | 0 Participants |
| Race (NIH/OMB) Unknown or Not Reported | 0 Participants |
| Race (NIH/OMB) White | 16 Participants |
| Region of Enrollment United States | 22 Participants |
| Sex: Female, Male Female | 11 Participants |
| Sex: Female, Male Male | 11 Participants |
Adverse events
| Event type | EG000 affected / at risk |
|---|---|
| deaths Total, all-cause mortality | 0 / 22 |
| other Total, other adverse events | 2 / 22 |
| serious Total, serious adverse events | 0 / 22 |
Outcome results
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.
Time frame: Baseline, Month 9, Month 24
Population: Participants with data at the respective timepoint
| Arm | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| Virtual Reality Stimulation in Patients with Eye Disorders | Change in Mean Deviation Index (MD) | Baseline | -14.69 Decibels | Standard Error 1.65 |
| Virtual Reality Stimulation in Patients with Eye Disorders | Change in Mean Deviation Index (MD) | Month 9 | -13.33 Decibels | Standard Error 2.02 |
| Virtual Reality Stimulation in Patients with Eye Disorders | Change in Mean Deviation Index (MD) | Month 24 | -9.51 Decibels | Standard Error 3.17 |
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.
Time frame: Baseline, Month 9, Month 24
Population: Participants with data at the respective timepoint
| Arm | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| Virtual Reality Stimulation in Patients with Eye Disorders | Change in Visual Field Index (VFI) | Baseline | 55.06 Percent of visual field | Standard Error 5.77 |
| Virtual Reality Stimulation in Patients with Eye Disorders | Change in Visual Field Index (VFI) | Month 9 | 57.66 Percent of visual field | Standard Error 6.86 |
| Virtual Reality Stimulation in Patients with Eye Disorders | Change in Visual Field Index (VFI) | Month 24 | 73.5 Percent of visual field | Standard Error 11.08 |
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).
Time frame: baseline and month 9
Population: Participants with glaucoma who reliably completed treatment
| Arm | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| Virtual Reality Stimulation in Patients with Eye Disorders | Change in Best Corrected Visual Acuity | Baseline | 0.34 logMAR | Standard Error 0.16 |
| Virtual Reality Stimulation in Patients with Eye Disorders | Change in Best Corrected Visual Acuity | month 9 | 0.13 logMAR | Standard Error 0.1 |
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.
Time frame: baseline and month 9
Population: Participants with glaucoma who reliably completed treatment
| Arm | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| Virtual Reality Stimulation in Patients with Eye Disorders | Retinal Layer Thickness Assessed by Optical Coherence Tomography (OCT) | baseline | 70.67 microns | Standard Error 4.98 |
| Virtual Reality Stimulation in Patients with Eye Disorders | Retinal Layer Thickness Assessed by Optical Coherence Tomography (OCT) | month 9 | 67.67 microns | Standard Error 3.18 |
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.
Time frame: baseline and 2 years