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OpenTrials
Completed

NCT Number: NCT04714424

Comparing Vision Tests in a Virtual Reality Headset to Existing Analogues

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.

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Key information

Age range

18 year and older

Sex eligibility

All sexes

Study type

Observational

Primary location

New York Eye & Ear Infirmary of Mount Sinai

New York, 10003, United States

About this study

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.

Who can participate

Healthy volunteers accepted: Yes

Only the study team can determine whether someone qualifies for participation.

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.

Treatment and study plan

Virtual Reality Headset

Device

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

Other names: Vive Pro

Primary outcomes

  1. Vision Field Perimetry

    Time frame: Day 1

    Vision field perimetry will me measured using Humphrey Vision Field Analyzer and a VR equivalent software.

  2. Acuity

    Time frame: Day 1

    Acuity will be measured using Tumbling E and LogMAR tests and a VR version of those tests.

  3. Contrast

    Time frame: Day 1

    Contrast sensitivity will be measured using the Pelli-Robson test and a VR version of the test.

  4. Color vision

    Time frame: Day 1

    Color vision will be measured by Ishihara plates and a VR version of the test.

Secondary outcomes

  1. Patient Satisfaction Survey

    Time frame: 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.

Sponsors and collaborators

Lead sponsor

Icahn School of Medicine at Mount Sinai

Other

Registry information

Official study title

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

Acronym: RTS1

Important dates

Study start
2020
Primary completion
2022
Study completion
2022
First posted
Jan 19, 2021
Registry last updated
Aug 28, 2024

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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