Ignite Creation Date:
2024-05-06 @ 3:41 PM
Last Modification Date:
2024-10-26 @ 1:54 PM
Study NCT ID:
NCT04714424
Status:
COMPLETED
Last Update Posted:
2022-06-24
First Post:
2021-01-14
Brief Title:
Comparing Vision Tests in a Virtual Reality Headset to Existing Analogues
Sponsor:
Icahn School of Medicine at Mount Sinai
Organization:
Icahn School of Medicine at Mount Sinai
Study Overview
Official Title:
Comparing Vision Tests Integrated Into a Virtual Reality Technology Against Its Currently Used Analogues
Status:
COMPLETED
Status Verified Date:
2024-08
Last Known Status:
RECRUITING
Delayed Posting:
No
If Stopped, Why?:
Not Stopped
Has Expanded Access:
False
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
RTS1
Brief Summary:
The purpose of this study is to compare the results of vision tests that are algorithmically derived and delivered through a virtual reality headset with those delivered through the existing technology standards eg Humphrey for field tests Tests that the researchers will be conducting include vision field perimetry Amsler acuity chart contrast- sensitivity and currently used office tests
Detailed Description:
Virtual reality VR constructs a 3-D reality right in a headset and the researchers are studying with what degree of accuracy it can be use to recreate vision tests that are used by eye doctors to screen and diagnose patients VR provides advantages that could be used to improve eye care once the technology is tested and compared to the currently used vision tests - such as limiting the costs duration and tedium associated with existing forms of vision screening tests By doing so the researchers hope to expand access to eye care by lowering the cost burden associated with vision tests In this study the research team will have subjects go through the VR versions of the test that are used in practice and analyze their results in comparison to one another After informed consent is obtained the research team will collect subject demographic information date of birth gender ethnicity race and clinically relevant medical history Afterward the research team will proceed to the virtual reality tests vision field perimetry Amsler Snellen chart contrast- sensitivity and currently used office tests The participants will undergo all the tests VR and non-VR which will be delivered in a randomized order The entire sequence will last 30 minutes to one hour for a single test The VR component will last about 5 minutes this being the only addition to the scheduled vision tests The sequence of VR non VR testing will be randomized Based on the previous studies that compared Humphrey MATRIX visual field and Swedish Interactive algorithm the effect size is determined to be at least 30 subjects and the goal is to reach N1000 participants
Study Oversight
Has Oversight DMC:
None
Is a FDA Regulated Drug?:
False
Is a FDA Regulated Device?:
True
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
None
Is an FDA AA801 Violation?:
None