Age-Related Macular Degeneration
Conditions
Brief summary
To assess the usability, tolerability, and repeatability of the set of VR headset-based tasks.
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.
Interventions
DIAGNOSTIC_TESTVirtual Reality (VR) Contrast Function Test
Patients perform a new Virtual Reality (VR) Contrast Function Test
Sponsors
Apellis Pharmaceuticals, Inc.
Augenklinik Zurich West
Study design
Allocation
NA
Intervention model
SINGLE_GROUP
Primary purpose
DIAGNOSTIC
Masking
NONE
Eligibility
Sex/Gender
ALL
Age
50 Years to 105 Years
Healthy volunteers
No
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)
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Usability, tolerability and repeatability | 20 minutes | 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. |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Contrast sensitivity function (CSF) | 10 minutes | Contrast sensitivity function (CSF) in decibel as area under curve (AUC). The CSF is also correlated to Snellen best corrected visual acuity (BCVA) |
Countries
Switzerland
Contacts
Primary ContactStephan Michels, MD
Outcome results
None listed