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Virtual Reality Mobility Assessment of Functional Vision in Retinal Disease

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Know the risks and potential benefits of clinical studies and talk to your health care provider before participating. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT04289571
Recruitment Status : Recruiting
First Posted : February 28, 2020
Last Update Posted : September 23, 2020
Sponsor:
Information provided by (Responsible Party):
National Institutes of Health Clinical Center (CC) ( National Eye Institute (NEI) )

Brief Summary:

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 1-2 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 and physical 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....


Condition or disease Intervention/treatment Phase
Cone-Rod Degeneration Rod-Cone Degeneration Diagnostic Test: VR Motility Tool Phase 1

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 patients 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. 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. 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. Participants will be required to attend up to two clinic visits within three months. VR testing will be the focus of the second clinic visit in order to A) examine the learning effect and B) quantify test-retest variability of VR 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 clinical measures of retinal structure and function (e.g., visual acuity, non-seeing area) and the mobility score from a PRO questionnaire/s. Other primary outcomes include quantifying the learning effect and test-retest variability of the VR test parameters. A secondary outcome is to examine 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.

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Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 165 participants
Allocation: N/A
Intervention Model: Single Group Assignment
Masking: None (Open Label)
Primary Purpose: Diagnostic
Official Title: An Observational Cross-Sectional Study of Virtual Reality Mobility Assessment of Functional Vision in Retinal Disease
Estimated Study Start Date : September 28, 2020
Estimated Primary Completion Date : December 31, 2022
Estimated Study Completion Date : August 15, 2024


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.




Primary Outcome Measures :
  1. VR mobility test parameters [ Time Frame: Life of the protocol ]
    Determine whether parameters from a recently developed VR mobility tool can serve as biomarkers of functional vision in participants with retinal disease.


Secondary Outcome Measures :
  1. VR mobility test parameters [ Time Frame: Variable ]
    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.

  2. Feasibility of the tool [ Time Frame: Variable ]
    Feasibility of the tool based on age and presence of physical disabilities.

  3. Effect of prior game play [ Time Frame: Variable ]
    Effect of prior or present computer game playing on baseline performance on the VR mobility tool.



Information from the National Library of Medicine

Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the contacts provided below. For general information, Learn About Clinical Studies.


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Ages Eligible for Study:   5 Years and older   (Child, Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   Yes
Criteria
  • 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 participants with retinal disease only:

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

  5. For healthy volunteers only:

    1. Participant must not have a retinal disease and have visual acuity of 20/20 or better, with or without correction (e.g., glasses or contact lens) in at least one 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.

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT04289571


Contacts
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Contact: Daniel W Claus, R.N. (301) 496-9058 daniel.claus@nih.gov

Locations
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United States, Maryland
National Institutes of Health Clinical Center Recruiting
Bethesda, Maryland, United States, 20892
Contact: For more information at the NIH Clinical Center contact Office of Patient Recruitment (OPR)    800-411-1222 ext TTY8664111010    prpl@cc.nih.gov   
Australia
Sydney Eye Hospital at the University of Sydney Recruiting
Sydney, Australia
Contact: John Grigg, M.D.    61293827300    john.grigg@sydney.edu.au   
Sponsors and Collaborators
National Eye Institute (NEI)
Investigators
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Principal Investigator: Brett G Jeffrey, Ph.D. National Eye Institute (NEI)
Additional Information:
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Responsible Party: National Eye Institute (NEI)
ClinicalTrials.gov Identifier: NCT04289571    
Other Study ID Numbers: 200026
20-EI-0026
First Posted: February 28, 2020    Key Record Dates
Last Update Posted: September 23, 2020
Last Verified: February 25, 2020

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Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
Keywords provided by National Institutes of Health Clinical Center (CC) ( National Eye Institute (NEI) ):
Cone-Rod Degeneration
Rod-Cone Degeneration
Eye
BCVA
OCT
Additional relevant MeSH terms:
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Retinal Diseases
Cone-Rod Dystrophies
Eye Diseases
Eye Diseases, Hereditary
Retinal Dystrophies
Retinal Degeneration
Genetic Diseases, Inborn