VR Assessment for Retinal Disease
Recruiting in Palo Alto (17 mi)
+2 other locations
Age: Any Age
Sex: Any
Travel: May Be Covered
Time Reimbursement: Varies
Trial Phase: Phase 1
Recruiting
Sponsor: National Eye Institute (NEI)
Disqualifiers: Other study, Non-compliance, others
No Placebo Group
Trial Summary
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.
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.
12345Is 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.
15678How 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.
23578Eligibility Criteria
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.
+1 more
Exclusion Criteria
I am currently participating in another clinical trial.
Participant is unable to comply with study procedures
Trial Timeline
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
Participant Groups
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.
1Treatment groups
Experimental Treatment
Group I: ParticipantsExperimental Treatment1 Intervention
Participants with retinal disease, healthy volunteers
Find a Clinic Near You
Research Locations NearbySelect from list below to view details:
National Institutes of Health Clinical CenterBethesda, MD
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Who Is Running the Clinical Trial?
National Eye Institute (NEI)Lead Sponsor
References
Stepping into the virtual unknown: feasibility study of a virtual reality-based test of ocular misalignment. [2018]IntroductionDissociated tests of strabismus provide valuable information for diagnosis and monitoring of ocular misalignment in patients with normal retinal correspondence. However, they are vulnerable to operator error and rely on a fixed head position. Virtual reality headsets obviate the need for head fixation, while providing other clear theoretical advantages, including complete control over the illumination and targets presented for the patient's interaction.PurposeWe compared the performance of a virtual reality-based test of ocular misalignment to that of the traditional Lees screen, to establish the feasibility of using virtual reality technology in ophthalmic settings in the future.MethodsThree patients underwent a traditional Lees screen test, and a virtual reality headset-based test of ocular motility. The virtual reality headset-based programme consisted of an initial test to measure horizontal and vertical deviation, followed by a test for torsion.ResultsThe pattern of deviation obtained using the virtual reality-based test showed agreement with that obtained from the Lees screen for patients with a fourth nerve palsy, comitant esotropia, and restrictive thyroid eye disease.ConclusionsThis study reports the first use of a virtual reality headset in assessing ocular misalignment, and demonstrates that it is a feasible dissociative test of strabismus.
To measure the amount of ocular deviation in strabismus patients with an eye-tracking virtual reality headset. [2021]To investigate the accuracy of a newly developed, eye-tracking virtual reality (VR)-based ocular deviation measurement system in strabismus patients.
Use of Virtual Reality Simulation to Identify Vision-Related Disability in Patients With Glaucoma. [2021]Clinical assessment of vision-related disability is hampered by the lack of instruments to assess visual performance in real-world situations. Interactive virtual reality (VR) environments displayed in a binocular stereoscopic VR headset have been designed, presumably simulating day-to-day activities to evaluate vision-related disability.
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]The purpose of this study is to investigate the use of a VR Headset in routine clinical practice as an additional source of information for patients with diabetic macular edema (DME) and their companions.
A Virtual Reality Orientation and Mobility Test for Inherited Retinal Degenerations: Testing a Proof-of-Concept After Gene Therapy. [2022]To test the ability of a virtual reality (VR) orientation and mobility (O&M) protocol to serve a measure of functional vision for patients with inherited retinal degenerations (IRDs).
Poster Session: Comparison of Dynamic Visual Acuity Assessments in Head-Mounted Technology and Traditional Laptop-based Method. [2023]An impairment in dynamic visual acuity (DVA) has been observed in astronauts shortly after they return to Earth.1 These transitional effects may lead to safety risks during interplanetary spaceflight. At this time, functional vision assessments are performed via laptop onboard the International Space Station. However, DVA is not performed as a standard assessment, and optimization of traditional assessments may aid in more efficient and frequent testing. As part of our group's NASA-funded head-mounted visual assessment system to detect subtle vision changes in long-duration spaceflight2, we present a method to measure DVA in virtual reality. An early validation study was conducted with 5 subjects comparing our novel assessment with a traditional laptop-based test. All participants had a best correctable visual acuity of 20/20, had no past ocular history, balancing disorders, or neurological history. Our DVA assessment framework was built in UnrealEngine 4. The early validation study confirmed that our VR-based DVA assessment performed similarly to traditional laptop-based test (0.485 and 0.525 LogMar respectively, Pearson Correlation = 0.911). A Bland-Altman plot and analysis demonstrated that our DVA assessment data fell within the upper and lower limits of agreement. Future studies are required to further validate this technology; however, these early results showcase VR-based DVA assessment as a promising alternative to laptop-based methods.
Simulation of eye disease in virtual reality. [2020]It is difficult to understand verbal descriptions of visual phenomenon if one has no such experience. Virtual Reality offers a unique opportunity to "experience" diminished vision and the problems it causes in daily life. We have developed an application to simulate age-related macular degeneration, glaucoma, protanopia, and diabetic retinopathy in a familiar setting. The application also includes the introduction of eye anatomy representing both normal and pathologic states. It is designed for patient education, health care practitioner training, and eye care specialist education.
Development of Immersive Virtual Reality Environment for Assessment of Functional Vision in people with Low Vision: A Pilot Study. [2022]Virtual Reality technology helps in creating virtual environments for evaluation of visual performance of low vision individuals with holistic experience. The purpose of this study was to develop a virtual reality (VR) platform for the objective assessment of functional vision in patients with low vision in two categories, central and peripheral vision loss .