An observational study in Ptosis, Macular Degeneration and Ametropia, sponsored by Icahn School of Medicine at Mount Sinai. Completed at 1 site in United States. Open to participants aged 18 Years and older, including healthy volunteers. Per ClinicalTrials.gov, last updated 2024-08-28.
Sponsored by Icahn School of Medicine at Mount Sinai · Observational
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.
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 N=1,000 participants.
1,474 studies on the registry are indexed under Macular Degeneration; 206 are open to participants now.
This study's enrollment of 84 is below the median of 106 across 421 observational studies indexed under Macular Degeneration.
Browse Macular Degeneration studies →Icahn School of Medicine at Mount Sinai is the lead sponsor of 764 studies on the registry; 181 are open to participants now.
Of its 121 completed or terminated interventional studies of FDA-regulated products, 82 (68%) have results posted.
Counted across the registry records on this site, refreshed daily.
Patients will be recruited from New York Eye and Ear Infirmary.
Exclusion Criteria:
Device: Virtual Reality Headset
Virtual reality (VR) - a 3-D reality right in a headset
Also known as: Vive Pro
Vision Field Perimetry
Vision field perimetry will me measured using Humphrey Vision Field Analyzer and a VR equivalent software.
Time frame: Day 1
Acuity
Acuity will be measured using Tumbling E and LogMAR tests and a VR version of those tests.
Time frame: Day 1
Contrast
Contrast sensitivity will be measured using the Pelli-Robson test and a VR version of the test.
Time frame: Day 1
Color vision
Color vision will be measured by Ishihara plates and a VR version of the test.
Time frame: Day 1
Patient Satisfaction Survey
The survey consists of Likert scale questions to understand the patient's experience with the VR and analogues. The scale is evaluated from 1 to 5, with 1 meaning "very poor" and 5 meaning "very good". Score for each section (HVFA and VR) is 3 to 15. Total scale is 6 to 30, with higher score indicating more satisfaction.
Time frame: Day 1
Plan to share: Yes — All of the individual participant data collected during the trial, after deidentification.
Supporting information: Study protocol, Sap, Icf, Csr, Analytic code
This study is completed, as verified in Aug 2024. You cannot join it, but the record below documents what was studied.
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Icahn School of Medicine at Mount Sinai