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

Virtual Reality (VR) Based Vision Test in Subjects With Age-related Macular Degeneration (AMD)

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

Study Overview

• Status: Recruiting
• Conditions: Age-Related Macular Degeneration
• Intervention / Treatment: Diagnostic test: Virtual Reality (VR) Contrast Function Test

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.

• Study Type: Interventional
• Enrollment (Estimated): 50
• Phase: Not Applicable

Contacts and Locations

• Study Contact: Name: Stephan Michels, MD; Phone Number: 00 +414454517; Email: info@augenklinik-zh.ch

Study Locations

• Switzerland
  • Zurich
    • Zürich, Zurich, Switzerland, 8047
      • Recruiting
      • Augenklinik Zurich West
      • Contact: Stephan Michels, MD; Phone Number: 00 +414454517; Email: info@augenklinik-zh.ch

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: Adult; Older Adult
• Accepts Healthy Volunteers: No

Description

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)

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Diagnostic
• Allocation: N/A
• Interventional Model: Single Group Assignment
• Masking: None (Open Label)

Number of Arms

1

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: VR-Visual Function Test; Assessment of virtual reality based vision function in Patients with AMD	Diagnostic test: Virtual Reality (VR) Contrast Function Test; Patients perform a new Virtual Reality (VR) Contrast Function Test

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Usability, tolerability and repeatability	The primary objective of this study is to assess the usability, tolerability, and repeatability of the set of VR headset-based tasks. To assess the usability and tolerability a patient survey is performed.	20 minutes

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Contrast sensitivity function (CSF)	Contrast sensitivity function (CSF) in decibel as area under curve (AUC). The CSF is also correlated to Snellen best corrected visual acuity (BCVA)	10 minutes

Collaborators and Investigators

• Sponsor: Augenklinik Zurich West
• Collaborators: Apellis Pharmaceuticals, Inc.
• Investigators: Principal Investigator: Stephan Michels, MD, Augenklinik Zurich West

Study record dates

Study Major Dates

• Study Start (Actual): October 20, 2022
• Primary Completion (Estimated): February 1, 2024
• Study Completion (Estimated): July 1, 2024

Study Registration Dates

• First Submitted: January 5, 2023
• First Submitted That Met QC Criteria: February 1, 2024
• First Posted (Estimated): February 5, 2024

Study Record Updates

• Last Update Posted (Estimated): February 5, 2024
• Last Update Submitted That Met QC Criteria: February 1, 2024
• Last Verified: August 1, 2023

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Eye Diseases; Retinal Degeneration; Retinal Diseases; Macular Degeneration
• Other Study ID Numbers: APL-GA-001

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No