Virtual Reality Based Vision Test in Patients With AMD

NCT ID: NCT06241625

Last Updated: 2024-02-05

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

UNKNOWN

Clinical Phase

NA

Total Enrollment

50 participants

Study Classification

INTERVENTIONAL

Study Start Date

2022-10-20

Study Completion Date

2024-07-31

Brief Summary

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

Detailed Description

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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.

Conditions

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Age-Related Macular Degeneration

Study Design

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Allocation Method

NA

Intervention Model

SINGLE_GROUP

Primary Study Purpose

DIAGNOSTIC

Blinding Strategy

NONE

Study Groups

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VR-Visual Function Test

Assessment of virtual reality based vision function in Patients with AMD

Group Type EXPERIMENTAL

Virtual Reality (VR) Contrast Function Test

Intervention Type DIAGNOSTIC_TEST

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

Interventions

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Virtual Reality (VR) Contrast Function Test

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

Intervention Type DIAGNOSTIC_TEST

Eligibility Criteria

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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)
Minimum Eligible Age

50 Years

Maximum Eligible Age

105 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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Apellis Pharmaceuticals, Inc.

INDUSTRY

Sponsor Role collaborator

Augenklinik Zurich West

OTHER

Sponsor Role lead

Responsible Party

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Responsibility Role SPONSOR

Principal Investigators

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Stephan Michels, MD

Role: PRINCIPAL_INVESTIGATOR

Augenklinik Zurich West

Locations

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Augenklinik Zurich West

Zurich, Canton of Zurich, Switzerland

Site Status RECRUITING

Countries

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Switzerland

Central Contacts

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Stephan Michels, MD

Role: CONTACT

+414454517 ext. 00

Facility Contacts

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Stephan Michels, MD

Role: primary

+414454517 ext. 00

Other Identifiers

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APL-GA-001

Identifier Type: -

Identifier Source: org_study_id

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