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Trial details imported from

For full trial details, please see the original record at

Registration number
Ethics application status
Date submitted
Date registered
Date last updated

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
Secondary ID [2] 0 0
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

Study type
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

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
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
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

Key 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

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.


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
Both males and females
Can healthy volunteers participate?
Key exclusion criteria

Study design
Purpose of the study
Allocation to intervention
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 1
Type of endpoint(s)
Statistical methods / analysis

Recruitment status
Data analysis
Reason for early stopping/withdrawal
Other reasons
Date of first participant enrolment
Date of last participant enrolment
Date of last data collection
Sample size
Accrual to date
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

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

Ethics approval
Ethics application status

Brief summary

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.


To learn if researchers can track changes in mobility in people with retinal disease using a
new VR tool.


People aged 5 and older with retinal disease that affects their vision, and healthy


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
Trial related presentations / publications
Public notes

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
Contact person for scientific queries

Summary results
For IPD and results data, please see