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Measuring Relative Afferent Pupillary Defect

NCT05799066 · Status: ACTIVE_NOT_RECRUITING · Phase: NA · Type: INTERVENTIONAL · Enrollment: 71

Last updated 2025-05-16

No results posted yet for this study

Summary

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.

Conditions

  • Relative Afferent Pupil Defect (RAPD)

Interventions

DIAGNOSTIC_TEST

Swinging Light test

The swinging light or pen light test with manual pupil measurements is the standard of care test for RAPD. This test consists of a light being shone in one eye for 3 to 4 seconds then shown in the other eye for 3 to 4 seconds, repeating 2 to 3 times. Pupils are measured manually immediately after the light test. Measurements are recorded in patient's medical record.

DIAGNOSTIC_TEST

Virtual Reality Head-Mounted Display (VR HMD)

A light is shone from within the VR HMD, pupillary measurements are taken and recorded by the machine learning (ML) algorithm.

Sponsors & Collaborators

  • University of Nevada, Reno

    collaborator OTHER

  • The University of Texas Medical Branch, Galveston

    lead OTHER

Principal Investigators

  • Kevin H Merkley, MD, MBA · University of Texas

Study Design

Allocation
NON_RANDOMIZED
Purpose
SCREENING
Masking
NONE
Model
PARALLEL

Eligibility

Min Age
18 Years
Max Age
85 Years
Sex
ALL
Healthy Volunteers
Yes

Timeline & Regulatory

Start
2023-05-04
Primary Completion
2026-05-14
Completion
2026-05-14

Countries

  • United States

Study Locations

More Related Trials

Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT05799066 on ClinicalTrials.gov