Virtual Reality Based Vision Test in Patients With AMD (GA-001)

Augenklinik Zurich West

Status: Enrolling

Conditions: Age-Related Macular Degeneration

Treatments: Diagnostic Test: Virtual Reality (VR) Contrast Function Test

Study type: Interventional

Funder types: Other; Industry

Identifiers

NCT06241625

APL-GA-001

Details and patient eligibility

About

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

Full 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.

Enrollment: 50 estimated patients

Sex: All

Ages: 50 to 105 years old

Volunteers: No Healthy Volunteers

Inclusion criteria

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

Exclusion criteria

1. Unwilling to use headset
2. Previous negative experience with a VR headset (eg, motion sickness, discomfort)
3. Any known oculomotor impairment that would impact the ability of the subject to perform the tasks (eg, nystagmus, proptosis, apraxia of eyelid opening)
4. 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)
5. Any physical limitations that would prohibit the use of the VR headset (eg, neck problems)

Trial design

Primary purpose: Diagnostic

Allocation: N/A

Interventional model: Single Group Assignment

Masking: None (Open label)

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50 participants in 1 patient group

VR-Visual Function Test

Experimental group

Description:

Assessment of virtual reality based vision function in Patients with AMD

Treatment:

Diagnostic Test: Virtual Reality (VR) Contrast Function Test