Virtual Reality Mobility Assessment of Functional Vision in Retinal Disease

An Observational Cross-Sectional Study of Virtual Reality Mobility Assessment of Functional Vision in Retinal Disease

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 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....

Study Overview

• Status: Recruiting
• Conditions: Cone-Rod Degeneration; Rod-Cone Degeneration
• Intervention / Treatment: Diagnostic test: VR Motility Tool

Detailed Description

Objective: Designing clinical trials for advanced retinal disease represents an especially difficult challenge due to the lack of suitable outcome measures. Clinical measures such as visual field and area of atrophy measured with multimodal imaging may be highly variable and/or difficult to measure in this population. A main contributor to disability in the visually impaired is poor mobility, which is a quality of life measure used to assess visually-guided behavior in low-vision patients. The goal of our study is to determine whether parameters from a recently developed virtual reality (VR) mobility assessment tool may serve as biomarkers of functional vision in participants with advanced retinal disease. The long-term goal will be to determine whether the VR mobility assessment tool parameters can document longitudinal changes in functional vision and serve as a suitable outcome measure for clinical trials in participants with advanced retinal disease.

Study Population: Up to 120 participants with retinal disease and 45 healthy volunteers will be recruited. The upper limit of 120 participants with retinal disease was chosen to allow approximately equal groups of 60 participants with rod-cone degeneration (RCD) and 60 participants with cone-rod degeneration (CRD) to represent groups of participants with peripheral visual field constriction and central vision loss, respectively. A total of 60 per group was chosen to A) allow feasibility to be determined across age groups (e.g., 5-11 yrs., 12-50 years, over 50 years) and B) to allow for a sufficient range of disease severity to examine VR mobility test sensitivity. The number of healthy volunteers (N=45) was chosen to provide about 15 participants across each of three age groups.

Design: In this multi-site observational study, VR mobility testing will be performed in participants with retinal disease. While the ultimate goal is to use this for advanced retinal disease, in the current study we will examine participants with a wide range of retinal disease severity to enable correlations between VR mobility parameters and markers of disease severity (e.g., field size, mobility scores from questionnaires). This analysis will also help determine the range of retinal disease severity for which VR mobility will be useful. Based on the simulation studies, we predict that participants should be able to repeat the VR course between four to eight times in a one-hour session. Testing will also include best corrected visual acuity (BCVA), visual fields, optical coherence tomography (OCT), autofluorescence imaging, ultra-widefield imaging and participant reported outcome (PRO) questionnaires. Two tests of photosensitivity, Visual Photosensitivity Threshold (VPT) and Palpebral Aperture Measurement (PAM) will also be recorded in a subset of participants known to be photosensitive (e.g., albinos, achromats, and CRD), and healthy volunteers at visit 001. Participants will be required to attend two to three clinic visits within three months. VR and photosensitivity testing will be the focus of the second and third clinic visit in order to A) examine the learning effect and B) quantify test-retest variability of VR and photosensitivity test parameters.

Outcome Measures: The primary outcome is to determine whether parameters from a recently developed VR mobility tool can serve as biomarkers of functional vision in participants with retinal disease. To this end, we will examine the correlation between VR mobility test parameters (e.g., accuracy, task time) and the mobility score from a PRO questionnaire/s. A secondary outcome is to examine the correlation between the VR mobility test parameters and clinical measures of retinal structure and function (e.g., visual acuity, non-seeing area). Other secondary outcomes include quantifying the learning effect and test-retest variability of the VR test parameters, exploring the feasibility of the tool based on age and presence of physical disabilities, determining the sensitivity of VR mobility test parameters to the presence and severity of retinal disease, determining the brightest background at which participants who experience photoaversion can navigate the VR maze, and determining whether prior or present computer game playing (e.g., number of hours, type of games played, computer game platform) influences baseline performance on the VR mobility tool.

• Study Type: Interventional
• Enrollment (Estimated): 165
• Phase: Phase 1

Contacts and Locations

• Study Contact: Name: Daniel W Claus, R.N.; Phone Number: (301) 451-1621; Email: daniel.claus@nih.gov
• Study Contact Backup: Name: Brett G Jeffrey, Ph.D.; Phone Number: (301) 402-2391; Email: jeffreybg@mail.nih.gov

Study Locations

• Australia
  • Sydney, Australia
    • Recruiting
    • University of Sydney
• United States
  • Maryland
    • Bethesda, Maryland, United States, 20892
      • Recruiting
      • National Institutes of Health Clinical Center
      • Contact: For more information at the NIH Clinical Center contact Office of Patient Recruitment (OPR); Phone Number: TTY8664111010 800-411-1222; Email: prpl@cc.nih.gov

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 5 years and older (Child, Adult, Older Adult)
• Accepts Healthy Volunteers: Yes

Description

• INCLUSION CRITERIA:

To be eligible, the following inclusion criteria must be met.

1. Participant must be five years of age or older.
2. Participant (or legal guardian) must understand and sign the protocol's informed consent document.
3. Participant must be able to cooperate with the testing required for this study.

4. For healthy volunteers only:

   1. Participant must not have retinal disease in either eye.

EXCLUSION CRITERIA:

A participant is not eligible if any of the following exclusion criteria are present.

1. Participant is in another investigational study and actively receiving study therapy.
2. Participant is unable to comply with study procedures.

STUDY EYE ELIGIBILITY CRITERIA:

The participant must have at least one eye meeting all inclusion criteria.

STUDY EYE INCLUSION CRITERIA:

1. Healthy Volunteers Only

   a. Study eye must have visual acuity of 20/20 or better, with or without correction (e.g., glasses or contact lens).

2. Participants with Retinal Disease Only

Study eye must have retinal disease, defined as retinal dysfunction and/or degeneration as previously established by standard clinical methods including perimetry, ERG and imaging.

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Diagnostic
• Allocation: N/A
• Interventional Model: Single Group Assignment
• Masking: None (Open Label)

Number of Arms

1

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: Participants; Participants with retinal disease, healthy volunteers	Diagnostic test: VR Motility Tool; Participant wears VR goggles and interacts with a visual avatar via a control unit to navigate four courses. Derived parameters automatically recorded by the VR system include number and type of collisions, walking speed, task time, and distance walked.

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
VR mobility test parameters	Determine whether parameters from a recently developed VR mobility tool can serve as biomarkers of functional vision in participants with retinal disease.	Life of the protocol

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
VR mobility test parameters	Correlation between VR mobility test parameters and clinical measures of retinal structure and function. Learning effect on and testretest variability of the VR test parameters. Sensitivity of VR mobility test parameters to the presence and severity of retinal disease.	Variable
Feasibility of the tool	Feasibility of the tool based on age and presence of physical disabilities.	Variable
Effect of prior game play	Effect of prior or present computer game playing on baseline performance on the VR mobility tool.	Variable

Collaborators and Investigators

• Sponsor: National Eye Institute (NEI)
• Investigators: Principal Investigator: Brett G Jeffrey, Ph.D., National Eye Institute (NEI)

Publications and helpful links

Helpful Links

• NIH Clinical Center Detailed Web Page

Study record dates

Study Major Dates

• Study Start (Actual): July 25, 2023
• Primary Completion (Estimated): December 31, 2030
• Study Completion (Estimated): December 31, 2030

Study Registration Dates

• First Submitted: February 27, 2020
• First Submitted That Met QC Criteria: February 27, 2020
• First Posted (Actual): February 28, 2020

Study Record Updates

• Last Update Posted (Estimated): October 9, 2023
• Last Update Submitted That Met QC Criteria: October 6, 2023
• Last Verified: October 5, 2023

More Information

Terms related to this study

• Keywords: OCT; Cone-Rod Degeneration; Rod-Cone Degeneration; Eye; BCVA
• Additional Relevant MeSH Terms: Eye Diseases; Retinal Degeneration; Genetic Diseases, Inborn; Eye Diseases, Hereditary; Retinal Dystrophies; Retinal Diseases; Cone-Rod Dystrophies
• Other Study ID Numbers: 200026; 20-EI-0026

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No
• product manufactured in and exported from the U.S.: No