NCT04980430

Brief Summary

Virtual reality (VR) is a relatively new, emerging field within healthcare. Studies have analyzed public perceptions of virtual reality in healthcare using social media, but few have actually demonstrated and educated these modalities to communities. Because vision care can be costly and inaccessible, especially in communities with few physicians, this study aims to evaluate whether communities would be open to new technology. For example, it has been determined that 80% of vision loss is preventable with adequate screening technology, a key factor in ameliorating the economic and emotional burden of eye disease. Therefore, through demonstrations and educational presentations by medical students, gaps in understanding perceptions, willingness to adopt, and general demographics of those seeking better eye care will be understood.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
1,000

participants targeted

Target at P75+ for all trials

Timeline
Completed

Started Oct 2020

Typical duration for all trials

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

October 1, 2020

Completed
10 months until next milestone

First Submitted

Initial submission to the registry

July 18, 2021

Completed
10 days until next milestone

First Posted

Study publicly available on registry

July 28, 2021

Completed
1.2 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

October 20, 2022

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

October 20, 2022

Completed
Last Updated

August 28, 2024

Status Verified

August 1, 2024

Enrollment Period

2.1 years

First QC Date

July 18, 2021

Last Update Submit

August 27, 2024

Conditions

Keywords

OphthalmologyVirtual RealityCommunityVision

Outcome Measures

Primary Outcomes (1)

  • Virtual Reality Assessment

    Participant assessment of VR technology. Items scored on a likert-scale format from 1 (strongly disagree) to 5 (strongly agree). Full scale from 13 to 65, with higher score indicating more favorable responses.

    Day 1

Secondary Outcomes (1)

  • Demographics Assessment

    Day 1

Study Arms (1)

Primary Care and Ophthalmology clinic patients

Participants will be recruited from primary care and ophthalmology clinics in New York City

Device: Virtual Reality

Interventions

Virtual Reality Demonstration

Primary Care and Ophthalmology clinic patients

Eligibility Criteria

Age18 Years+
Sexall
Healthy VolunteersYes
Age GroupsAdult (18-64), Older Adult (65+)
Sampling MethodNon-Probability Sample
Study Population

Subjects will be recruited from primary care and ophthalmology clinics in New York City. Participants can schedule a time to participate in the study on their own or may be recruited by a student at their appointment.

You may qualify if:

  • Males and females of any race
  • At least 18 years of age
  • Participants must be able to understand and provide verbal and written consent. Only participants who undergo the demonstration of the technology and consent to the study after full explanation will be included in research.

You may not qualify if:

  • \- People who have undergone intraocular surgery less than six months ago, and potential contraindication for visual field test that include anxiety disorder, pregnancy, seizure disorder, cardiac pacemaker or another implantable device, severe vertigo or balance.

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Mount Sinai Ophthalmology Faculty Practice Associates

New York, New York, 10029, United States

Location

Study Officials

  • James Chelnis, MD

    Icahn School of Medicine at Mount Sinai

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
observational
Observational Model
OTHER
Time Perspective
PROSPECTIVE
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Assistant Clinical Professor

Study Record Dates

First Submitted

July 18, 2021

First Posted

July 28, 2021

Study Start

October 1, 2020

Primary Completion

October 20, 2022

Study Completion

October 20, 2022

Last Updated

August 28, 2024

Record last verified: 2024-08

Data Sharing

IPD Sharing
Will share

All of the individual participant data collected during the trial, after deidentification.

Shared Documents
STUDY PROTOCOL, SAP
Time Frame
Immediately following publication. No end date.
Access Criteria
Investigators whose proposed use of the data has been approved by an independent review committee ('learned intermediary') identified for this purpose. Any purpose. Data available on specific request and will be shared securely as CSV

Locations