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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

Titles & IDs
Public title
Virtual Reality Mobility Assessment of Functional Vision in Retinal Disease
Scientific title
An Observational Cross-Sectional Study of Virtual Reality Mobility Assessment of Functional Vision in Retinal Disease
Secondary ID [1] 0 0
20-EI-0026
Secondary ID [2] 0 0
200026
Universal Trial Number (UTN)
Trial acronym
Linked study record

Health condition
Health condition(s) or problem(s) studied:
Cone-Rod Degeneration 0 0
Rod-Cone Degeneration 0 0
Condition category
Condition code
Eye 0 0 0 0
Diseases / disorders of the eye
Human Genetics and Inherited Disorders 0 0 0 0
Other human genetics and inherited disorders

Intervention/exposure
Study type
Interventional
Description of intervention(s) / exposure
Diagnosis / Prognosis - VR Mobility Tool

Experimental: Participants - Participants with retinal disease, healthy volunteers


Diagnosis / Prognosis: VR Mobility 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.
Intervention code [1] 0 0
Diagnosis / Prognosis
Comparator / control treatment
Control group

Outcomes
Primary outcome [1] 0 0
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
Assessment method [1] 0 0
Examine the correlation between VR mobility test parameters(e.g., accuracy, task time) and the mobility score from a PRO questionnaire/s.
Timepoint [1] 0 0
Three months
Secondary outcome [1] 0 0
Determination of the brightest background at which participants who experience photoaversion can navigate the VR maze.
Assessment method [1] 0 0
Determining the brightest background at which participants who experience photoaversion can navigate the VR maze.
Timepoint [1] 0 0
Three months
Secondary outcome [2] 0 0
Sensitivity of VR mobility test parameters to the presence and severity of retinal disease.
Assessment method [2] 0 0
Determining the sensitivity of VR mobility test parameters to the presence and severity of retinal disease.
Timepoint [2] 0 0
Three Months
Secondary outcome [3] 0 0
Learning effect on and test-retest variability of the VR test parameters.
Assessment method [3] 0 0
Quantifying the learning effect on and testretest variability of the VR test parameters.
Timepoint [3] 0 0
Three Months
Secondary outcome [4] 0 0
Effect of prior game play
Assessment method [4] 0 0
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.
Timepoint [4] 0 0
Three Months
Secondary outcome [5] 0 0
Feasibility of the tool
Assessment method [5] 0 0
Determining the feasibility of the tool based on age and presence of physical disabilities.
Timepoint [5] 0 0
Three Months
Secondary outcome [6] 0 0
Correlation between the VR mobility test parameters and clinical measures of retinal structure and function (e.g., visual acuity, non-seeing area)
Assessment method [6] 0 0
Determining the correlation between VR mobility test parameters and clinical measures of retinal structure and function.
Timepoint [6] 0 0
Three Months

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.
Minimum age
5 Years
Maximum age
120 Years
Sex
Both males and females
Can healthy volunteers participate?
Yes
Key exclusion criteria

Study design
Purpose of the study
Diagnosis
Allocation to intervention
Not applicable
Procedure for enrolling a subject and allocating the treatment (allocation concealment procedures)
Methods used to generate the sequence in which subjects will be randomised (sequence generation)
Masking / blinding
Open (masking not used)
Who is / are masked / blinded?



Intervention assignment
Single group
Other design features
Phase
Phase 1
Type of endpoint/s
Statistical methods / analysis

Recruitment
Recruitment status
Recruiting
Data analysis
Reason for early stopping/withdrawal
Other reasons
Date of first participant enrolment
Anticipated
Actual
25/07/2023
Date of last participant enrolment
Anticipated
Actual
Date of last data collection
Anticipated
31/12/2030
Actual
Sample size
Target
165
Accrual to date
Final
Recruitment in Australia
Recruitment state(s)
Recruitment hospital [1] 0 0
University of Sydney - Sydney
Recruitment postcode(s) [1] 0 0
- Sydney
Recruitment outside Australia
Country [1] 0 0
United States of America
State/province [1] 0 0
Maryland

Funding & Sponsors
Primary sponsor type
Government body
Name
National Eye Institute (NEI)
Country

Ethics approval
Ethics application status

Summary
Brief summary
Trial website
Public notes

Contacts
Principal investigator
Name 0 0
Brett G Jeffrey, Ph.D.
Address 0 0
National Eye Institute (NEI)
Country 0 0
Phone 0 0
Email 0 0
Contact person for public queries
Name 0 0
Daniel W Claus, R.N.
Address 0 0
Country 0 0
Phone 0 0
(301) 451-1621
Email 0 0
daniel.claus@nih.gov
Contact person for scientific queries

Data sharing statement


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