Virtual Reality Based Vision Test in Patients With AMD

Age-Related Macular Degeneration Clinical Trial

— GA-001  

Official title:

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

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT06241625
• Other study ID #: APL-GA-001
• Status: Recruiting
• Phase: N/A
• Start date: October 20, 2022
• Est. completion date: July 2024

Study information

• Verified date: August 2023
• Source: Augenklinik Zurich West
• Contact: Stephan Michels, MD
• Phone: +414454517
• Email: info[@]augenklinik-zh.ch
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial Summary

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

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.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 50
• Est. completion date: July 2024
• Est. primary completion date: February 2024
• Accepts healthy volunteers: No
• Gender: All
• Age group: 50 Years to 105 Years

Eligibility

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)

Related Conditions & MeSH terms

• Age-Related Macular Degeneration
• Macular Degeneration

Intervention

Diagnostic Test:
• Virtual Reality (VR) Contrast Function Test
Patients perform a new Virtual Reality (VR) Contrast Function Test

Locations

Country	Name	City	State
Switzerland	Augenklinik Zurich West	Zürich	Zurich

Sponsors (2)

Lead Sponsor	Collaborator
Augenklinik Zurich West	Apellis Pharmaceuticals, Inc.

Country where clinical trial is conducted

Switzerland, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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	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