71 Participants Needed

VR Technology for Pupil Disorders

(RAPD Trial)

KH
SM
Overseen ByStacy M Schreiber Lopez, AA, BS, MA
Age: 18+
Sex: Any
Trial Phase: Academic
Sponsor: The University of Texas Medical Branch, Galveston
No Placebo GroupAll trial participants will receive the active study treatment (no placebo)

Trial Summary

Will I have to stop taking my current medications?

The trial information does not specify whether you need to stop taking your current medications. It seems focused on testing a device for eye conditions, so it's unlikely to require changes to your medication, but you should confirm with the study team.

What data supports the effectiveness of the treatment Swinging Light test, Virtual Reality Head-Mounted Display (VR HMD) for pupil disorders?

Research shows that VR technology can be effectively used in eye care, such as detecting eye misalignment and enhancing visual skills like stereopsis (depth perception) and visual acuity (sharpness of vision). VR headsets have also been used successfully to engage children in eye tests, suggesting they could be a useful tool for pupil disorder treatments.12345

Is VR technology safe for use in treating pupil disorders?

Research shows that using VR headsets for eye tests in children and adults is generally safe, allowing for free movement and reliable eye measurements without significant safety concerns.12567

How is the VR Head-Mounted Display treatment for pupil disorders different from other treatments?

The VR Head-Mounted Display treatment for pupil disorders is unique because it uses virtual reality technology to detect and assess eye conditions like relative afferent pupillary defects (RAPDs) through eye tracking, offering a non-invasive and interactive way to monitor and diagnose eye issues compared to traditional methods.12368

What is the purpose of this trial?

The goal of this prospective reliability study is to test the effectiveness of a commercially available, off-the-shelf virtual reality head-mounted display (VR HMD) and machine learning (ML) algorithms in detecting Relative Afferent Pupillary Defect (RAPD) in a group of subjects with known RAPD and another group with no known RAPD.The main questions it aims to answer are:* Does the use of the VR HMD and ML to replace the standard of care swinging flashlight test provide a more reliable and objective pupil measurement to detect RAPD?* Can RAPD be detected by the VR HMD and ML algorithms at an earlier stage than the standard of care swinging light test?Participants will be asked to undergo the standard of care swinging flashlight test, have their pupils manually measured, then have the test repeated using the VR HMD and ML.Researchers will compare the measurements taken manually, following the standard of care swinging light test and those recorded by the VR HMD and ML to help answer the above questions.

Research Team

KH

Kevin H Merkley, MD, MBA

Principal Investigator

University of Texas

Eligibility Criteria

This trial is for UTMB clinic patients aged 18-85 with known Relative Afferent Pupillary Defect (RAPD) or vision disorders like glaucoma. It's not for those outside this age range, non-English speakers, people uncomfortable with VR devices or glasses, and those with congenital pupil issues.

Inclusion Criteria

This criterion refers to the exclusion of 60 patients with known Relative Afferent Pupillary Defect (RAPD).
I have been diagnosed with a vision disorder like glaucoma or diabetic retinopathy.
Referred to study by treating eye doctor
See 4 more

Exclusion Criteria

You have a history of pupils being abnormal due to birth or injury.
Those whose pupils were dilated during the standard of care examination deemed by treating eye doctor not to be eligible to participate in study
You have trouble wearing glasses.
See 4 more

Timeline

Screening

Participants are screened for eligibility to participate in the trial

1-2 weeks
1 visit (in-person)

Baseline Assessment

Participants undergo the standard of care swinging flashlight test and manual pupil measurements

1 day
1 visit (in-person)

Intervention

Participants undergo testing with the VR HMD and ML algorithms to measure pupillary response

1 day
1 visit (in-person)

Follow-up

Participants are monitored for any immediate adverse effects post-intervention

1 day
No additional visits required

Treatment Details

Interventions

  • Swinging Light test
  • Virtual Reality Head-Mounted Display (VR HMD)
Trial Overview Researchers are testing if a virtual reality headset combined with machine learning can detect RAPD more reliably and earlier than the standard swinging flashlight test. Participants will undergo both methods to compare effectiveness.
Participant Groups
2Treatment groups
Experimental Treatment
Group I: No Known RAPDExperimental Treatment2 Interventions
Participants with no known RAPD will be administered the standard of care swinging light test and pupil measurements taken manually, then administered the light test using the VR HMD and ML.
Group II: Known RAPDExperimental Treatment2 Interventions
Participants with known RAPD will be administered the standard of care swinging light test and pupil measurements taken manually, then administered the light test using the VR HMD and ML.

Find a Clinic Near You

Who Is Running the Clinical Trial?

The University of Texas Medical Branch, Galveston

Lead Sponsor

Trials
263
Recruited
55,400+

University of Nevada, Reno

Collaborator

Trials
34
Recruited
20,200+

Findings from Research

Current VR headsets have a minimum angular resolution of 0.41 logMAR on average, which is inadequate for reliable visual acuity testing and may not be suitable for treating conditions like amblyopia.
The average field of view for VR headsets is about 50.2°, which is significantly lower than manufacturer claims, but it may still be sufficient for certain visual field tests, although concerns exist for vergence testing due to varying eye-to-screen distances.
Measuring Virtual Reality Headset Resolution and Field of View: Implications for Vision Care Applications.Lynn, MH., Luo, G., Tomasi, M., et al.[2021]
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.
Stepping into the virtual unknown: feasibility study of a virtual reality-based test of ocular misalignment.Nesaratnam, N., Thomas, P., Vivian, A.[2018]
Virtual Reality (VR) has been shown to effectively enhance motor and functional skills in both children and adults, leveraging brain plasticity to improve cognitive function and motor disabilities in various neurological disorders.
Clinical studies indicate that VR training can significantly improve visual functions such as stereopsis and visual acuity in ophthalmological conditions, offering a non-invasive alternative to traditional methods that require eye occlusion.
A systematic review: Virtual-reality-based techniques for human exercises and health improvement.Ali, SG., Wang, X., Li, P., et al.[2023]

References

Measuring Virtual Reality Headset Resolution and Field of View: Implications for Vision Care Applications. [2021]
Stepping into the virtual unknown: feasibility study of a virtual reality-based test of ocular misalignment. [2018]
Detection of Relative Afferent Pupillary Defects Using Eye Tracking and a VR Headset. [2023]
A systematic review: Virtual-reality-based techniques for human exercises and health improvement. [2023]
Maintaining fixation by children in a virtual reality version of pupil perimetry. [2023]
A Study to Assess the Feasibility of Utilising Virtual Reality for the Treatment of Accommodative and Vergence Infacility. [2022]
Effect of virtual reality headset wear on the tear film: A randomised crossover study. [2020]
Use of infrared TV cameras built into head-mounted display to measure torsional eye movements. [2019]
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