VR Assessment for Retinal Disease

Recruiting at 2 trial locations

Overseen By Brett G Jeffrey, Ph.D.

Age: Any Age

Sex: Any

Trial Phase: Phase 1

Sponsor: National Eye Institute (NEI)

Disqualifiers: Other study, Non-compliance, others

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

Compensation: Varies

Number of Visits: 3

165 Participants Needed

What You Need to Know Before You Apply

What is the purpose of this trial?

This trial aims to determine if a virtual reality (VR) tool, the VR Motility Tool, can effectively track mobility changes in people with retinal disease, which affects vision and navigation abilities. Researchers seek to establish whether VR offers a more accurate assessment of these mobility issues. The trial invites individuals aged 5 and older with retinal disease affecting their vision, as well as healthy volunteers without retinal disease. Participants will engage in VR tasks, answer questions about their vision and mobility, and undergo various eye exams. As a Phase 1 trial, the research focuses on understanding how the treatment works in people, offering participants the opportunity to experience this innovative approach firsthand.

Will I have to stop taking my current medications?

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

What prior data suggests that this VR tool is safe for assessing mobility in people with retinal disease?

Research shows that the VR motility tool safely assesses movement in individuals with retinal disease. Earlier studies tested the tool's ability to detect changes in movement for those with retinal issues. These studies found that it tracks changes in visual behavior without causing harm. Participants navigate virtual obstacle courses, which they have managed well. No serious side effects have been reported from using the VR setup. As this is a Phase 1 trial, the primary focus is on safety, and early studies suggest it is well-tolerated. ^{1 2 3 4 5}

Why are researchers excited about this trial?

The VR Motility Tool is unique because it uses virtual reality technology to assess retinal disease, offering a non-invasive and immersive way to evaluate eye function. Unlike traditional methods that rely on physical tests and imaging, this tool provides real-time feedback in a dynamic virtual environment. Researchers are excited about this approach because it has the potential to offer more precise and engaging assessments, which could lead to earlier detection and better understanding of retinal conditions.

What evidence suggests that this VR tool is effective for assessing mobility in retinal disease?

Research shows that virtual reality (VR) tools can effectively track the movement of people with retinal disease. Studies have found that VR systems can measure how well individuals with vision problems navigate, serving as indicators of their functional vision. This trial will use the VR Motility Tool to assess how vision issues affect daily life by mimicking real-world challenges. Previous findings support VR as a promising method for evaluating mobility issues related to vision in both children and adults with retinal diseases. Early studies demonstrated that VR can measure the impact of vision loss on movement. ^{1 2 3 4 5}

Who Is on the Research Team?

Brett G Jeffrey, Ph.D.

Principal Investigator

National Eye Institute (NEI)

Are You a Good Fit for This Trial?

This trial is for people aged 5 and older with retinal diseases that affect vision, such as Cone-Rod Dystrophy or Retinitis Pigmentosa. Healthy volunteers without retinal disease can also join. Participants must be able to follow the study's procedures and those under legal age need consent from a guardian.

Inclusion Criteria

I am at least five years old.

I can follow the testing procedures required for this study.

I do not have any eye diseases.

Exclusion Criteria

I am currently participating in another clinical trial.

Participant is unable to comply with study procedures

Timeline for a Trial Participant

Screening

Participants are screened for eligibility to participate in the trial

2-4 weeks

Baseline Assessment

Participants undergo initial assessments including medical history, eye exams, and questionnaires about vision and mobility issues

1-2 weeks

1 visit (in-person)

VR Mobility Testing

Participants perform VR mobility tests and photosensitivity assessments to evaluate functional vision

3 months

2-3 visits (in-person)

Follow-up

Participants are monitored for changes in functional vision and test-retest variability

4 weeks

What Are the Treatments Tested in This Trial?

Interventions

• VR Motility Tool

Trial Overview The study is testing a new Virtual Reality (VR) tool designed to assess how well people with retinal disease can move through virtual obstacle courses. The goal is to see if this VR tool can accurately track changes in their mobility over time.

How Is the Trial Designed?

Group I: Participants Experimental Treatment 1 Intervention

Participants with retinal disease, healthy volunteers

Who Is Running the Clinical Trial?

National Eye Institute (NEI)

Lead Sponsor

Trials

572

Recruited

1,320,000+

Published Research Related to This Trial

The study successfully tested a virtual reality headset for assessing ocular misalignment, showing that it can provide results consistent with traditional methods like the Lees screen.

This innovative approach eliminates the need for fixed head positions and allows for better control over testing conditions, suggesting it could enhance the diagnosis and monitoring of strabismus in clinical settings.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Stepping into the virtual unknown: feasibility study of a virtual reality-based test of ocular misalignment. Nesaratnam, N., Thomas, P., Vivian, A.[2018]

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 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]

In a study of 98 glaucoma patients and 50 healthy individuals, virtual reality (VR) simulations revealed that patients with glaucoma took significantly longer to complete tasks like shopping and navigating stairs at night, indicating a higher level of vision-related disability compared to healthy individuals.

The study found that 59.1% of glaucoma patients experienced vision-related disability in at least one daily task, particularly in low-light conditions, highlighting the importance of using VR to assess real-world visual performance and understand the impact of visual impairment on daily activities.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Use of Virtual Reality Simulation to Identify Vision-Related Disability in Patients With Glaucoma. Lam, AKN., To, E., Weinreb, RN., et al.[2021]

A study involving 121 patients with diabetic macular edema (DME) showed that using a VR Headset significantly improved patients' and their companions' understanding of DME and its treatment, with knowledge scores increasing from an average of 13.2 to 15.5 correct answers after the VR experience.

Over 85% of participants felt better informed after using the VR Headset, and both patients and healthcare professionals rated the experience positively, suggesting that VR could enhance patient education and adherence to treatment.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

See clearer: survey on the subjective and objective information levels as well as perception and information transfer using virtual reality headsets in patients with diabetic macular edema receiving anti-VEGF treatment. Enders, C., Duncker, T., Schürks, M., et al.[2023]

A new Virtual Reality application has been developed to simulate various visual impairments, such as age-related macular degeneration and glaucoma, allowing users to experience the challenges faced by individuals with these conditions.

This application serves multiple purposes, including patient education and training for healthcare practitioners and eye care specialists, enhancing understanding of both normal and pathological eye anatomy.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Simulation of eye disease in virtual reality. Jin, B., Ai, Z., Rasmussen, M.[2020]

The newly developed VR-based ocular deviation measurement system demonstrated a strong correlation with the traditional alternative prism cover test (APCT) in 38 strabismus patients, with an intraclass correlation coefficient of 0.897, indicating it can accurately assess eye deviation.

This VR system showed different measurement outcomes for esotropia and exotropia, suggesting it may need further calibration for specific types of strabismus, but it represents a significant advancement towards digitizing strabismus assessments and could facilitate telemedicine applications.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

To measure the amount of ocular deviation in strabismus patients with an eye-tracking virtual reality headset. Yeh, PH., Liu, CH., Sun, MH., et al.[2021]

Citations

1. clinicaltrials.gov clinicaltrials.gov/study/NCT04289571

Virtual Reality Mobility Assessment of Functional Vision in ... Outcome Measures: The primary outcome is to determine whether parameters from a recently developed VR mobility tool can serve as biomarkers of functional vision ...

2. pmc.ncbi.nlm.nih.gov pmc.ncbi.nlm.nih.gov/articles/PMC7936670/

A Virtual Reality Orientation and Mobility Test for Inherited ... This study provides proof-of-concept data in support for the use of VR-O&M systems to quantify the impact that the visual dysfunction and ...

3. arxiv.org arxiv.org/html/2504.13735v1

Orientation and mobility test in virtual reality, a tool for ... Purpose: The purpose of this study was to develop and evaluate a novel virtual reality seated orientation and mobility (VR-S-O&M) test protocol ...

4. pmc.ncbi.nlm.nih.gov pmc.ncbi.nlm.nih.gov/articles/PMC9896841/

Optimization and Validation of a Virtual Reality Orientation ... To optimize a virtual reality (VR) orientation and mobility (O&M) test of functional vision in patients with inherited retinal degenerations (IRDs).

5. www3.pennmedicine.org www3.pennmedicine.org/departments-and-centers/ophthalmology/about-us/news/department-news/virtual-reality

Virtual Reality May Provide Method of Assessing Vision in ... Virtual reality (VR) technology may offer an effective method of assessing functional vision in children and adults with inherited retinal diseases.