Trial Outcomes & Findings for Virtual Reality for Enhancement of Vision (NCT NCT07071129)

Results Overview

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.

Recruitment status

TERMINATED

Study phase

NA

Target enrollment

22 participants

Primary outcome timeframe

Baseline, Month 9, Month 24

Results posted on

2025-12-10

Participant Flow

Unit of analysis: Eyes

Participant milestones

Participant milestones
Measure	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.	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.
Overall Study STARTED	22 32	0 0
Overall Study Diagnosis of Glaucoma	21 31	0 0
Overall Study COMPLETED	5 7	0 0
Overall Study NOT COMPLETED	17 25	0 0

Reasons for withdrawal

Withdrawal data not reported

Baseline Characteristics

Virtual Reality for Enhancement of Vision

Baseline characteristics by cohort

Baseline characteristics by cohort
Measure	Virtual Reality Stimulation in Patients With Eye Disorders n=22 Participants Participants use the VR headset for up to 2 years, followed by up to 1 year follow-up period.
Age, Continuous	66.5 years n=4 Participants
Sex: Female, Male Female	11 Participants n=4 Participants
Sex: Female, Male Male	11 Participants n=4 Participants
Race (NIH/OMB) American Indian or Alaska Native	0 Participants n=4 Participants
Race (NIH/OMB) Asian	5 Participants n=4 Participants
Race (NIH/OMB) Native Hawaiian or Other Pacific Islander	0 Participants n=4 Participants
Race (NIH/OMB) Black or African American	1 Participants n=4 Participants
Race (NIH/OMB) White	16 Participants n=4 Participants
Race (NIH/OMB) More than one race	0 Participants n=4 Participants
Race (NIH/OMB) Unknown or Not Reported	0 Participants n=4 Participants
Region of Enrollment United States	22 Participants n=4 Participants

PRIMARY outcome

Timeframe: Baseline, Month 9, Month 24

Population: Participants with data at the respective timepoint

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.

Outcome measures

Outcome measures
Measure	Virtual Reality Stimulation in Patients with Eye Disorders n=32 Eyes Participants use the VR headset for up to 2 years, followed by up to 1 year follow-up period.
Change in Visual Field Index (VFI) Baseline	55.06 Percent of visual field Standard Error 5.77
Change in Visual Field Index (VFI) Month 9	57.66 Percent of visual field Standard Error 6.86
Change in Visual Field Index (VFI) Month 24	73.5 Percent of visual field Standard Error 11.08

PRIMARY outcome

Timeframe: Baseline, Month 9, Month 24

Population: Participants with data at the respective timepoint

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.

Outcome measures

Outcome measures
Measure	Virtual Reality Stimulation in Patients with Eye Disorders n=31 Eyes Participants use the VR headset for up to 2 years, followed by up to 1 year follow-up period.
Change in Mean Deviation Index (MD) Baseline	-14.69 Decibels Standard Error 1.65
Change in Mean Deviation Index (MD) Month 9	-13.33 Decibels Standard Error 2.02
Change in Mean Deviation Index (MD) Month 24	-9.51 Decibels Standard Error 3.17

SECONDARY outcome

Timeframe: baseline and month 9

Population: Participants with glaucoma who reliably completed treatment

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.

Outcome measures

Outcome measures
Measure	Virtual Reality Stimulation in Patients with Eye Disorders n=8 Participants Participants use the VR headset for up to 2 years, followed by up to 1 year follow-up period.
Retinal Layer Thickness Assessed by Optical Coherence Tomography (OCT) baseline	70.67 microns Standard Error 4.98
Retinal Layer Thickness Assessed by Optical Coherence Tomography (OCT) month 9	67.67 microns Standard Error 3.18

SECONDARY outcome

Timeframe: baseline and month 9

Population: Participants with glaucoma who reliably completed treatment

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).

Outcome measures

Outcome measures
Measure	Virtual Reality Stimulation in Patients with Eye Disorders n=8 Participants Participants use the VR headset for up to 2 years, followed by up to 1 year follow-up period.
Change in Best Corrected Visual Acuity Baseline	0.34 logMAR Standard Error 0.16
Change in Best Corrected Visual Acuity month 9	0.13 logMAR Standard Error 0.10

OTHER_PRE_SPECIFIED outcome

Timeframe: 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.

Outcome measures

Outcome data not reported

Adverse Events

Virtual Reality Stimulation in Patients with Eye Disorders

Serious events: 0 serious events

Other events: 2 other events

Deaths: 0 deaths

Serious adverse events

Adverse event data not reported

Other adverse events

Other adverse events
Measure	Virtual Reality Stimulation in Patients with Eye Disorders n=22 participants at risk Participants use the VR headset for up to 2 years, followed by up to 1 year follow-up period.
Musculoskeletal and connective tissue disorders Increased TMJ pain	4.5% 1/22 • Up to 2 years treatment
Musculoskeletal and connective tissue disorders Body Aches	4.5% 1/22 • Up to 2 years treatment
Nervous system disorders Neurological storm	4.5% 1/22 • Up to 2 years treatment

Additional Information

Jeffrey Goldberg, MD, PhD

Stanford University

Phone: (650) 723-6137

Email: [email protected]

Results disclosure agreements

Principal investigator is a sponsor employee
Publication restrictions are in place