Study Results
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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UNKNOWN
NA
50 participants
INTERVENTIONAL
2022-10-20
2024-07-31
Brief Summary
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Detailed Description
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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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Study Design
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NA
SINGLE_GROUP
DIAGNOSTIC
NONE
Study Groups
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VR-Visual Function Test
Assessment of virtual reality based vision function in Patients with AMD
Virtual Reality (VR) Contrast Function 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
Eligibility Criteria
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Inclusion Criteria
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
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)
50 Years
105 Years
ALL
No
Sponsors
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Apellis Pharmaceuticals, Inc.
INDUSTRY
Augenklinik Zurich West
OTHER
Responsible Party
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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
Countries
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Central Contacts
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Facility Contacts
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Other Identifiers
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APL-GA-001
Identifier Type: -
Identifier Source: org_study_id
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