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Protocol Details

An Observational Cross-Sectional Study of Virtual Reality Mobility Assessment of Functional Vision in Retinal Disease

This study is currently recruiting participants.

Summary | Eligibility | Citations | Contacts

Summary

Number

20-EI-0026

Sponsoring Institute

National Eye Institute (NEI)

Recruitment Detail

Type: Participants currently recruited/enrolled
Gender: Male & Female
Min Age: 5
Max Age: N/A

Referral Letter Required

No

Population Exclusion(s)

None

Keywords

Cone-Rod Degeneration;
Rod-Cone Degeneration;
Eye;
BCVA;
OCT

Recruitment Keyword(s)

None

Condition(s)

Cone-Rod Degeneration;
Rod-Cone Degeneration

Investigational Drug(s)

None

Investigational Device(s)

None

Intervention(s)

Diagnostic Test: VR Motility Tool

Supporting Site

National Eye Institute

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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Eligibility

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:

a. 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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Citations:

Not Provided

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Contacts:

Principal Investigator

Referral Contact

For more information:

Brett G. Jeffrey, Ph.D.
National Eye Institute (NEI)
National Institutes of Health
Building 10
Room 10C442
10 Center Drive
Bethesda, Maryland 20892
(301) 402-2391
jeffreybg@mail.nih.gov

Daniel W. Claus, R.N.
National Eye Institute (NEI)
National Institutes of Health
Building 10
Room 10D45
10 Center Drive
Bethesda, Maryland 20892
(301) 451-1621
daniel.claus@nih.gov

Office of Patient Recruitment
National Institutes of Health Clinical Center (CC)
Building 61, 10 Cloister Court
Bethesda, Maryland 20892
Toll Free: 1-800-411-1222
Local Phone: 301-451-4383
TTY: TTY Users Dial 7-1-1
ccopr@nih.gov

Clinical Trials Number:

NCT04289571

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