Comparing Vision Tests in a Virtual Reality Headset to Existing Analogues

NCT ID: NCT04714424

Last Updated: 2024-08-28

Basic Information

• Recruitment Status: COMPLETED
• Total Enrollment: 84 participants
• Study Classification: OBSERVATIONAL
• Study Start Date: 2020-01-13
• Study Completion Date: 2022-10-24

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 N=1,000 participants.

Conditions

Ptosis; Macular Degeneration; Ametropia

Study Design

• Observational Model Type: OTHER
• Study Time Perspective: CROSS_SECTIONAL

Study Groups

Participants undergoing vision exams

Virtual Reality Headset

Intervention Type: DEVICE

Virtual reality (VR) - a 3-D reality right in a headset

Interventions

Virtual Reality Headset

Virtual reality (VR) - a 3-D reality right in a headset

Intervention Type: DEVICE

Other Intervention Names

Vive Pro

Eligibility Criteria

Inclusion Criteria

• Male and female patients of any race who are at least 18 years of age and can understand and provide verbal and written informed consent are eligible for this study.

Exclusion Criteria

• Patients who have had intraocular surgery less than six months ago,
• Potential contraindication for visual field test that include anxiety disorder, pregnancy, seizure disorder,cardiac pacemaker or another implantable device, severe vertigo or balance issues.

• Minimum Eligible Age: 18 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: Yes

Sponsors

Icahn School of Medicine at Mount Sinai

OTHER

Sponsor Role: lead

Responsible Party

James Chelnis

Assistant Clinical Professor, MD

Responsibility Role: PRINCIPAL_INVESTIGATOR

Principal Investigators

James Chelnis, MD

Role: PRINCIPAL_INVESTIGATOR

New York Eye and Ear Infirmary of Mount Sinai

Locations

New York Eye & Ear Infirmary of Mount Sinai

New York, New York, United States

Countries

United States

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Other Identifiers

GCO 19-03280

Identifier Type: -

Identifier Source: org_study_id