RTS1: Comparing Vision Tests in a Virtual Reality Headset to Existing Analogues

Sponsor

Icahn School of Medicine at Mount Sinai (Other)

Overall Status

Recruiting

CT.gov ID

NCT04714424

Collaborator

(none)

1,000

Enrollment

Location

43.6

Anticipated Duration (Months)

Patients Per Site Per Month

Study Details

Study Description

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.

Condition or Disease	Intervention/Treatment	Phase
Ptosis Macular Degeneration Ametropia	Device: Virtual Reality Headset

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.

Study Design

Study Type:

Observational [Patient Registry]

Anticipated Enrollment :

1000 participants

Observational Model:

Other

Time Perspective:

Cross-Sectional

Official Title:

Comparing Vision Tests Integrated Into a Virtual Reality Technology Against Its Currently Used Analogues

Actual Study Start Date :

Nov 13, 2019

Anticipated Primary Completion Date :

Jul 1, 2023

Anticipated Study Completion Date :

Jul 1, 2023

Arms and Interventions

Arm	Intervention/Treatment
Participants undergoing vision exams	Device: Virtual Reality Headset Virtual reality (VR) - a 3-D reality right in a headset Other Names: Vive Pro

Arm

Intervention/Treatment

Participants undergoing vision exams

Device: Virtual Reality Headset

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

Other Names:

Vive Pro

Outcome Measures

Primary Outcome Measures

Vision Field Perimetry [Day 1]
Vision field perimetry will me measured using Humphrey Vision Field Analyzer and a VR equivalent software.
Acuity [Day 1]
Acuity will be measured using Tumbling E and LogMAR tests and a VR version of those tests.
Contrast [Day 1]
Contrast sensitivity will be measured using the Pelli-Robson test and a VR version of the test.
Color vision [Day 1]
Color vision will be measured by Ishihara plates and a VR version of the test.

Secondary Outcome Measures

Patient Satisfaction Survey [Day 1]
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.

Eligibility Criteria

Criteria

Ages Eligible for Study:

18 Years and Older

Sexes Eligible for Study:

All

Accepts Healthy Volunteers:

Yes

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.