Virtual Reality Navigation for Partial Vision Loss

Overseen By Evan Burr

Age: 18+

Sex: Any

Trial Phase: Academic

Sponsor: University of Rochester

Disqualifiers: Ocular disease, Brain injury, Cognitive disorders, others

No Placebo Group All trial participants will receive the active study treatment (no placebo)

Compensation: Varies

Number of Visits: 1

40 Participants Needed

What You Need to Know Before You Apply

What is the purpose of this trial?

This trial studies how individuals with partial vision loss from brain injury manage tasks like driving. Participants will use a Virtual Reality (VR) program, the Virtual Reality Driving Task, to simulate driving while researchers observe their steering behavior. The trial includes two groups: one with cortically-induced blindness (vision loss due to brain damage) and a healthy control group with normal vision. Ideal candidates for the vision loss group have experienced vision loss on both sides after a stroke or similar brain injury and have reliable visual field defects. As an unphased trial, this study allows participants to contribute to groundbreaking research that could enhance rehabilitation strategies for vision loss.

Will I have to stop taking my current medications?

The trial information does not specify whether you need to stop taking your current medications.

What prior data suggests that this Virtual Reality Driving Task is safe for participants?

Research has shown that virtual reality (VR) tools, like the one used in this study, have been safely applied in similar contexts. For instance, VR has tested driving skills in individuals with vision issues from conditions such as glaucoma. These studies did not identify major safety concerns. VR has also assisted those with vision loss after a stroke, which aligns somewhat with the focus of this trial.

Although these studies address different conditions, the VR technology itself is generally user-friendly. Participants typically do not experience serious side effects. However, some may feel slightly dizzy or tired, particularly if unfamiliar with VR. Overall, VR has proven to be a safe method for studying how vision problems impact tasks like driving. ^{1 2 3 4 5}

Why are researchers excited about this trial?

Researchers are excited about the Virtual Reality (VR) Driving Task because it offers a novel approach to managing partial vision loss, particularly in conditions like cortical blindness. Unlike traditional rehabilitation methods that might rely on physical exercises or assistive devices, this VR task leverages immersive technology to simulate real-world navigation challenges in a safe, controlled environment. This could potentially enhance spatial awareness and adaptative navigation skills for those with vision impairments. By comparing performance in individuals with cortical blindness to healthy controls, researchers hope to uncover new insights into how VR can be used to improve daily functioning for those affected by partial vision loss.

What evidence suggests that this Virtual Reality Driving Task is effective for understanding cortically-induced blindness?

Research has shown that virtual reality (VR) can improve vision problems, particularly for those with vision loss due to brain-related issues. Studies have found that VR programs enhance how individuals learn to see and understand visual information, even with partial vision impairment. This trial will evaluate the effectiveness of a VR Driving Task for two groups: one cohort with cortical blindness and another of healthy controls. This method may also reduce mental fatigue, making activities like driving in a simulator easier and more effective. Consequently, using VR for driving tasks might help individuals with vision loss from brain issues better navigate their surroundings by improving visual processing. ^{1 4 5 6 7}

Are You a Good Fit for This Trial?

This trial is for US or Canadian residents aged 21-75 who've had a one-sided stroke affecting vision, confirmed by MRI/CT scans. Participants must have consistent visual field defects in both eyes and be able to understand instructions in English. They should consent themselves and can wear contacts if needed.

Inclusion Criteria

I had a stroke affecting my vision between ages 21-75, confirmed by MRI or CT.

Reliable visual field defects in both eyes (homonymous defects) as measured by Humphrey or equivalent perimetry.

I am capable and willing to give my consent for treatment.

Timeline for a Trial Participant

Screening

Participants are screened for eligibility to participate in the trial

2-4 weeks

Virtual Reality Driving Task

Participants perform a driving task in VR, steering through parameterized turns while maintaining their virtual vehicle centered between road edges

1 day

1 visit (in-person)

Follow-up

Participants are monitored for safety and effectiveness after the VR task

4 weeks

What Are the Treatments Tested in This Trial?

Interventions

• Virtual Reality Driving Task

Trial Overview Researchers are using Virtual Reality (VR) to study how people with cortically-induced blindness from strokes adapt when driving. The VR program simulates real-world environments, tracking steering behavior to learn about changes in visual processing.

How Is the Trial Designed?

Group I: Virtual Reality (VR) Driving Task: Healthy Control Cohort Experimental Treatment 1 Intervention

Healthy controls with no vision loss will perform a driving task in VR, in which they must steer through a series of parameterized turns while maintaining their virtual vehicle centered between the two red lines delineating the "road" edge.

Group II: Virtual Reality (VR) Driving Task: Cortically Blind Cohort Experimental Treatment 1 Intervention

Persons who have sustained cortical blindness will perform a driving task in VR, in which they must steer through a series of parameterized turns while maintaining their virtual vehicle centered between the two red lines delineating the "road" edge.

Who Is Running the Clinical Trial?

University of Rochester

Lead Sponsor

Trials

883

Recruited

555,000+

Rochester Institute of Technology

Collaborator

Trials

15

Recruited

5,500+

Published Research Related to This Trial

The study involved 10 patients with retinitis pigmentosa and tested their ability to navigate obstacles in a virtual shopping mall environment while either walking on a treadmill or standing, revealing that walking improved their accuracy in identifying obstacles compared to standing.

Using control subjects with simulated tunnel vision showed that while they performed well at wide angles, their accuracy decreased at narrow angles, highlighting that a treadmill interface is crucial for mimicking natural movement and perceptual behavior in virtual reality for low vision assessments.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Heading assessment by "tunnel vision" patients and control subjects standing or walking in a virtual reality environment. Apfelbaum, H., Pelah, A., Peli, E.[2022]

Training individuals with low vision using virtual reality can effectively teach them safe street crossing skills, as demonstrated by a study involving 12 participants who improved their timing for crossing streets after training.

Both virtual and real street training resulted in significant safety improvements, with 90% of participants' 'GO' calls occurring in the safer early half of the pedestrian phase after training, indicating that virtual reality can be a viable alternative to traditional training methods.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Individuals with severely impaired vision can learn useful orientation and mobility skills in virtual streets and can use them to improve real street safety. Bowman, EL., Liu, L.[2022]

In a driving simulator study with 12 normally sighted participants simulating visual impairment, detection of pedestrians was significantly better when they appeared before using a monocular bioptic telescope (77% detection) compared to when they appeared while using the telescope (28%).

The study suggests that normally sighted individuals with simulated acuity loss can compensate for the ring scotoma effect of a monocular bioptic telescope using their fellow eye, as evidenced by the lack of significant difference in pedestrian detection rates for binocular users.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Evaluation of a Paradigm to Investigate Detection of Road Hazards when Using a Bioptic Telescope. Bowers, AR., Bronstad, PM., Spano, LP., et al.[2019]

In a study involving 30 participants with normal vision and 30 with hemianopia or quadrantanopia, 73% of hemianopic and 88% of quadrantanopic drivers were rated as safe to drive, indicating that some individuals with these visual field deficits can drive safely.

Driving performance issues in those with hemianopia or quadrantanopia were linked to difficulties in lane positioning, steering steadiness, and gap judgment, suggesting that visual processing speed and sensitivity are critical factors in assessing driving safety.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

On-road driving performance by persons with hemianopia and quadrantanopia. Wood, JM., McGwin, G., Elgin, J., et al.[2022]

A patient with visuo-spatial neglect showed significant improvement after using the 'Salzburg Visual Field Trainer' VR system for 254 days, achieving a visual field expansion of 48.8% in the left eye and 36.8% in the right eye.

Subjective reports indicated a remarkable 317% improvement in visual field functionality, suggesting that VR-based interventions can be effective for patients with visual field loss.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Visual field improvement in neglect after virtual reality intervention: a single-case study. Leitner, MC., Hawelka, S.[2021]

The study tested a virtual reality (VR) orientation and mobility (O&M) protocol on 10 participants, including 3 patients with RPE65-associated Leber Congenital Amaurosis, showing that VR-O&M can effectively measure functional vision in patients with inherited retinal degenerations (IRDs).

Post-gene therapy, patients demonstrated significant improvements in visual sensitivity and navigation performance, with fewer collisions and faster navigation times, indicating that VR-O&M can quantify the impact of visual dysfunction and treatment outcomes.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

A Virtual Reality Orientation and Mobility Test for Inherited Retinal Degenerations: Testing a Proof-of-Concept After Gene Therapy. Aleman, TS., Miller, AJ., Maguire, KH., et al.[2022]

A virtual reality platform was developed to test and train users on an electronic travel aid, which includes a wearable haptic feedback device, showing significant improvements in navigation for individuals simulating three types of visual impairments.

Participants using the electronic travel aid completed tasks faster and experienced fewer collisions, particularly those simulating diabetic retinopathy and glaucoma, suggesting that this technology could enhance mobility rehabilitation for people with visual impairments.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Virtual reality as a means to explore assistive technologies for the visually impaired. Ricci, FS., Boldini, A., Ma, X., et al.[2023]

A new virtual reality platform was developed to objectively assess functional vision in individuals with low vision, specifically targeting those with central and peripheral vision loss.

The pilot study revealed that participants with low vision performed significantly worse on visual tasks compared to those with normal vision, with the peripheral field loss group taking the longest to complete tasks, highlighting the challenges faced by these individuals in realistic scenarios.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Development of Immersive Virtual Reality Environment for Assessment of Functional Vision in people with Low Vision: A Pilot Study. Gopalakrishnan, S., Samson, CE., Kumar, M., et al.[2022]

Citations

1. pmc.ncbi.nlm.nih.gov pmc.ncbi.nlm.nih.gov/articles/PMC11418143/

Reduction of cognitive fatigue and improved performance at a ... Reduction of cognitive fatigue and improved performance at a VR-based driving simulator using tRNS

2. pmc.ncbi.nlm.nih.gov pmc.ncbi.nlm.nih.gov/articles/PMC11109502/

Digital therapeutics using virtual reality‐based visual ... Digital therapeutics using virtual reality‐based visual perceptual learning for visual field defects in stroke: A double‐blind randomized trial.

3. withpower.com withpower.com/trial/phase-stroke-9-2023-504fd

Virtual Reality Navigation for Partial Vision Loss Using a novel Virtual Reality (VR) program, the researchers will gather data on steering behavior in a variety of simulated naturalistic environments. Through ...

4. eyeandear.org eyeandear.org/2024/04/introducing-street-lab-improving-functional-outcomes-in-low-vision-rehabilitation/

Improving Functional Outcomes in Low Vision Rehabilitation The StreetLab assesses an individual's needs and their perception of their impairments, which may include visual field loss and visual acuity ...

5. clinicaltrials.gov clinicaltrials.gov/study/NCT05085210

Improving Visual Field Deficits With Noninvasive Brain ... This is a randomized, pilot interventional study in participants with visual field deficit (VFD) caused by cortical lesion. Damage to the primary visual ...

6. sciencedirect.com sciencedirect.com/science/article/pii/S2589004224017619

Reduction of cognitive fatigue and improved performance ... Cognitive fatigue (CF) increases accident risk reducing performance, especially during complex tasks such as driving.

7. pmc.ncbi.nlm.nih.gov pmc.ncbi.nlm.nih.gov/articles/PMC3804259/

Driving Simulation as a Performance-based Test of Visual ... Driving simulators can be used as a performance-based test for evaluation of functional impairment in glaucoma.