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Trial details imported from ClinicalTrials.gov
For full trial details, please see the original record at
https://clinicaltrials.gov/study/NCT04289571
Registration number
NCT04289571
Ethics application status
Date submitted
27/02/2020
Date registered
28/02/2020
Date last updated
15/08/2024
Titles & IDs
Public title
Virtual Reality Mobility Assessment of Functional Vision in Retinal Disease
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Scientific title
An Observational Cross-Sectional Study of Virtual Reality Mobility Assessment of Functional Vision in Retinal Disease
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Secondary ID [1]
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20-EI-0026
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Secondary ID [2]
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200026
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Universal Trial Number (UTN)
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Trial acronym
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Linked study record
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Health condition
Health condition(s) or problem(s) studied:
Cone-Rod Degeneration
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Rod-Cone Degeneration
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Condition category
Condition code
Eye
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Diseases / disorders of the eye
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Human Genetics and Inherited Disorders
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Other human genetics and inherited disorders
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Intervention/exposure
Study type
Interventional
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Description of intervention(s) / exposure
Diagnosis / Prognosis - VR Motility Tool
Experimental: Participants - Participants with retinal disease, healthy volunteers
Diagnosis / Prognosis: 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.
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Intervention code [1]
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Diagnosis / Prognosis
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Comparator / control treatment
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Control group
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Outcomes
Primary outcome [1]
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VR mobility test parameters
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Assessment method [1]
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Determine whether parameters from a recently developed VR mobility tool can serve as biomarkers of functional vision in participants with retinal disease.
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Timepoint [1]
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Life of the protocol
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Secondary outcome [1]
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VR mobility test parameters
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Assessment method [1]
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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.
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Timepoint [1]
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Variable
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Secondary outcome [2]
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Feasibility of the tool
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Assessment method [2]
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Feasibility of the tool based on age and presence of physical disabilities.
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Timepoint [2]
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Variable
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Secondary outcome [3]
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Effect of prior game play
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Assessment method [3]
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Effect of prior or present computer game playing on baseline performance on the VR mobility tool.
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Timepoint [3]
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Variable
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Eligibility
Key inclusion 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 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.
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Minimum age
5
Years
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Maximum age
No limit
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Sex
Both males and females
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Can healthy volunteers participate?
Yes
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Key exclusion criteria
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Study design
Purpose of the study
Diagnosis
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Allocation to intervention
NA
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Procedure for enrolling a subject and allocating the treatment (allocation concealment procedures)
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Methods used to generate the sequence in which subjects will be randomised (sequence generation)
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Masking / blinding
Open (masking not used)
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Who is / are masked / blinded?
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Intervention assignment
Single group
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Other design features
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Phase
Phase 1
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Type of endpoint/s
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Statistical methods / analysis
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Recruitment
Recruitment status
Recruiting
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Data analysis
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Reason for early stopping/withdrawal
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Other reasons
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Date of first participant enrolment
Anticipated
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Actual
25/07/2023
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Date of last participant enrolment
Anticipated
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Actual
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Date of last data collection
Anticipated
31/12/2030
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Actual
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Sample size
Target
165
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Accrual to date
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Final
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Recruitment in Australia
Recruitment state(s)
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Recruitment hospital [1]
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University of Sydney - Sydney
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Recruitment postcode(s) [1]
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- Sydney
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Recruitment outside Australia
Country [1]
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United States of America
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State/province [1]
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Maryland
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Funding & Sponsors
Primary sponsor type
Government body
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Name
National Eye Institute (NEI)
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Address
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Country
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Ethics approval
Ethics application status
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Summary
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 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....
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Trial website
https://clinicaltrials.gov/study/NCT04289571
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Trial related presentations / publications
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Public notes
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Contacts
Principal investigator
Name
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Brett G Jeffrey, Ph.D.
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Address
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National Eye Institute (NEI)
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Phone
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Fax
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Email
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Contact person for public queries
Name
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Daniel W Claus, R.N.
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Address
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Country
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Phone
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(301) 451-1621
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Fax
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Email
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[email protected]
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Contact person for scientific queries
No information has been provided regarding IPD availability
What supporting documents are/will be available?
No Supporting Document Provided
Results publications and other study-related documents
No documents have been uploaded by study researchers.
Results not provided in
https://clinicaltrials.gov/study/NCT04289571
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