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Trial details imported from ClinicalTrials.gov

For full trial details, please see the original record at https://clinicaltrials.gov/show/NCT04289571




Registration number
NCT04289571
Ethics application status
Date submitted
27/02/2020
Date registered
28/02/2020
Date last updated
2/12/2020

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 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.

Intervention code [1] 0 0
Diagnosis / Prognosis
Comparator / control treatment
Control group

Outcomes
Primary outcome [1] 0 0
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.
Timepoint [1] 0 0
Life of the protocol
Secondary outcome [1] 0 0
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.
Timepoint [1] 0 0
Variable
Secondary outcome [2] 0 0
Feasibility of the tool - Feasibility of the tool based on age and presence of physical disabilities.
Timepoint [2] 0 0
Variable
Secondary outcome [3] 0 0
Effect of prior game play - Effect of prior or present computer game playing on baseline performance on the VR mobility tool.
Timepoint [3] 0 0
Variable

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 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.
Minimum age
5 Years
Maximum age
No limit
Gender
Both males and females
Can healthy volunteers participate?
Yes
Key exclusion criteria

Study design
Purpose of the study
Diagnosis
Allocation to intervention
N/A
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
Date of last participant enrolment
Anticipated
Actual
Date of last data collection
Anticipated
Actual
Sample size
Target
Accrual to date
Final
Recruitment in Australia
Recruitment state(s)
Recruitment hospital [1] 0 0
Sydney Eye Hospital at the 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)
Address
Country

Ethics approval
Ethics application status

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 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....
Trial website
https://clinicaltrials.gov/show/NCT04289571
Trial related presentations / publications
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
Fax 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) 496-9058
Fax 0 0
Email 0 0
daniel.claus@nih.gov
Contact person for scientific queries

Summary results
For IPD and results data, please see https://clinicaltrials.gov/show/NCT04289571