Health TrialsbyHealthPanel

Virtual Reality Mobility Assessment of Functional Vision in Retinal Disease

ConditionsCone-Rod DegenerationRod-Cone Degeneration
Trial statusRecruiting
Trial phasePhase 1
Trial typeInterventional
Biological sexAll
Age5-120
SponsorNational Eye Institute (NEI)

About this trial

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 or sit in front of a screen 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....

Eligibility criteria

This trial accepts healthy volunteers

Qualifiers

For the NEI site: Participant must be five years of age or older.

For the USyd site: Participant must be thirteen (13) years of age or older.

Participant (or legal guardian) must understand and be willing to sign the protocol s informed consent document.

Participant must be able to cooperate with the testing required for this study.

Disqualifiers

Participant is in another investigational study and actively receiving study therapy.

Participant is unable to comply with study procedures.

Healthy Volunteers Only

Participants with Retinal Disease Only

Trial design

Design model

Single group

Treatments tested in this trial

  • VR Mobility Tool

    Diagnostic test

    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.

Treatment groups

165 Participants
are divided into 1 treatment group
Group A: ParticipantsExperimental treatment 1 intervention

Trial outcomes

Primary outcomes

1

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

Examine the correlation between VR mobility test parameters(e.g., accuracy, task time) and the mobility score from a PRO questionnaire/s.

Time frame
Three months

Secondary outcomes

1

Determination of the brightest background at which participants who experience photoaversion can navigate the VR maze.

Determining the brightest background at which participants who experience photoaversion can navigate the VR maze.

Time frame
Three months
2

Sensitivity of VR mobility test parameters to the presence and severity of retinal disease.

Determining the sensitivity of VR mobility test parameters to the presence and severity of retinal disease.

Time frame
Three Months
3

Learning effect on and test-retest variability of the VR test parameters.

Quantifying the learning effect on and testretest variability of the VR test parameters.

Time frame
Three Months
4

Effect of prior game play

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.

Time frame
Three Months

Other outcomes

Sponsors and contacts

Click on the lead sponsor to view all of their trials.

National Eye Institute (NEI)

Lead sponsor

Source ClinicalTrials.gov
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