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?

Background: The retina is a thin layer of tissue at the back of the eye. Retinal disease usually reduces a person s mobility because it affects how he or she moves through familiar and unfamiliar environments. Researchers want to see if a virtual reality (VR) tool can provide an easier and more accurate way to assess mobility. Objective: To learn if researchers can track changes in mobility in people with retinal disease using a new VR tool. Eligibility: People aged 5 and older with retinal disease that affects their vision, and healthy volunteers. Design: Participants will have 2-3 clinic visits. Participants will wear goggles or sit in front of a screen while sitting. Using a game controller, they will navigate through 4 obstacle courses presented in VR. Participants will have a medical history exam. They will answer questions about their family history. They will fill out questionnaires about the vision and mobility issues they have in their daily lives. Participants will have a complete eye exam. They will read letters from a chart. Their eye pressure will be measured. Their pupils may be dilated with eye drops. Pictures of their eye will be taken. Lights will be shined in their eyes. Participants will take a visual field test. For this, they will look into a dome and press a button when they see a light. Participants will have an electroretinogram. For this, they will sit in the dark with their eyes patched. Then their eyes will be numbed with eye drops and they will wear contact lenses while watching flashing lights. Participants will have optical coherence tomography. This is a noninvasive procedure. It produces cross-sectional pictures of the retina....

Will I have to stop taking my current medications?

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

Is the VR Assessment for Retinal Disease generally safe for humans?

The studies suggest that using virtual reality (VR) for eye assessments is feasible and shows similar results to traditional methods, indicating it is generally safe for human use. ^{1 2 3 4 5}

How is the VR treatment for retinal disease different from other treatments?

The VR treatment for retinal disease is unique because it uses virtual reality technology to simulate real-world environments, allowing for a more accurate assessment of visual performance and vision-related disabilities compared to traditional methods. ^{1 4 5 6 7}

What data supports the effectiveness of the VR Motility Tool treatment for retinal disease?

Research shows that virtual reality (VR) technology can accurately measure eye alignment and movement, similar to traditional methods, and can assess functional vision in patients with retinal conditions. This suggests that VR tools may effectively evaluate and monitor vision-related issues in retinal diseases. ^{1 2 6 7 8}

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 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]

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]

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 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]

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. England pubmed.ncbi.nlm.nih.gov

Stepping into the virtual unknown: feasibility study of a virtual reality-based test of ocular misalignment. [2018]

2. England pubmed.ncbi.nlm.nih.gov

To measure the amount of ocular deviation in strabismus patients with an eye-tracking virtual reality headset. [2021]

3. United States pubmed.ncbi.nlm.nih.gov

Use of Virtual Reality Simulation to Identify Vision-Related Disability in Patients With Glaucoma. [2021]

4. Germany 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. [2023]

5. New Zealand pubmed.ncbi.nlm.nih.gov

A Virtual Reality Orientation and Mobility Test for Inherited Retinal Degenerations: Testing a Proof-of-Concept After Gene Therapy. [2022]

6. United States pubmed.ncbi.nlm.nih.gov

Poster Session: Comparison of Dynamic Visual Acuity Assessments in Head-Mounted Technology and Traditional Laptop-based Method. [2023]

7. United States pubmed.ncbi.nlm.nih.gov

Simulation of eye disease in virtual reality. [2020]

8. Nepal pubmed.ncbi.nlm.nih.gov

Development of Immersive Virtual Reality Environment for Assessment of Functional Vision in people with Low Vision: A Pilot Study. [2022]