Virtual Reality Based Vision Test in Patients With AMD

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Description

To assess the usability, tolerability, and repeatability of the set of VR headset-based tasks.

Study Overview

Start Date
October 20, 2022
Completion Date
July 1, 2024
Enrollment
50
Date Posted
February 5, 2024
Accepts Healthy Volunteers?
No
Gender
All

Locations

Full Address
Augenklinik Zurich West
Zürich, Zurich 8047, Switzerland

Eligibility

Minimum Age (years)
50
Maximum Age (years)
105
Eligibility Criteria
Inclusion Criteria:

Subjects ≥18 years of age diagnosed with AMD
Subject Snellen BCVA score is 20/100 or better
Ability to undergo quality optical coherence tomography (OCT) imaging
Willing and able to give written informed consent

Exclusion Criteria:

Unwilling to use headset
Previous negative experience with a VR headset (eg, motion sickness, discomfort)
Any known oculomotor impairment that would impact the ability of the subject to perform the tasks (eg, nystagmus, proptosis, apraxia of eyelid opening)
Any manifest neurological or cognitive condition that would impair the subject's understanding or performance on the test (eg, Alzheimer's disease, Parkinson's disease)
Any physical limitations that would prohibit the use of the VR headset (eg, neck problems)

Study Contact Info

Study Contact Name
Stephan Michels, MD
Study Contact Email
Study Contact Phone

Contact Listings Owner Form

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Other Details

FDA Regulated Drug?
No
FDA Regulated Device?
No
Detailed Description
In order to bridge the gap between the existing functional measures and AMD lesions, researchers are considering the use of VR tools.

This study is designed to assess the contrast sensitivity function mapping test (CSF radial sweep) in an elderly population with AMD.

The primary objective of this study is to assess the usability, tolerability, and repeatability of the set of VR headset-based tasks.

The secondary objective of this study is to assess the relationship between the metrics generated by VR-based functional tasks and the metrics derived from conventional clinical measurements of retinal anatomy and visual function.

The primary efficacy endpoint is the Contrast sensitivity function (CSF) area under curve (AUC) correlation to Snellen BCVA.
NCTid (if applicable)
NCT06241625