RTS2: Community Interest in Vision Screening Technology

Sponsor
Icahn School of Medicine at Mount Sinai (Other)
Overall Status
Recruiting
CT.gov ID
NCT04980430
Collaborator
(none)
1,000
1
26
38.5

Study Details

Study Description

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.

Condition or Disease Intervention/Treatment Phase
  • Device: Virtual Reality

Detailed Description

This study is critical to show healthcare leaders that communities seek new, lower cost, and more accessible technologies for vision care. This study will also be used to expand use of the technology in other communities and prove a use case for it. Ultimately, this can help benefit communities to ensure that all are receiving proper vision care and to address common conditions in a timely manner.

If participants agree to participate, individuals will be educated about vision care and the use of virtual reality technology by a medical student or trained volunteer using a VR headset. This entire process will take about 5 minutes. Participants will be allowed to take breaks and medical students and/or volunteers will be nearby to answer any questions they may have throughout the study. There will be no results given to patients during the study nor will they be advised to use any information to inform future healthcare decisions. The purpose of the study is demonstrative.

After the demonstration, a survey will be given to each participant about their experience with the VR technology along with demographic information. This will be kept confidential and will only be accessed by those approved. The survey will take approximately 5 minutes. In addition, we will offer educational materials on the conditions that the vision tests are used to screen for.

Study Design

Study Type:
Observational
Anticipated Enrollment :
1000 participants
Observational Model:
Other
Time Perspective:
Prospective
Official Title:
Evaluating Community Interest in Virtual Reality Vision Screening Technology
Actual Study Start Date :
Jun 1, 2021
Anticipated Primary Completion Date :
Aug 1, 2023
Anticipated Study Completion Date :
Aug 1, 2023

Arms and Interventions

Arm Intervention/Treatment
Primary Care and Ophthalmology clinic patients

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

Device: Virtual Reality
Virtual Reality Demonstration

Outcome Measures

Primary Outcome Measures

  1. Virtual Reality Assessment [Day 1]

    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.

Secondary Outcome Measures

  1. Demographics Assessment [Day 1]

    Survey to evaluate participant demographics and vision care needs. This is not a scored or scaled survey.

Eligibility Criteria

Criteria

Ages Eligible for Study:
18 Years and Older
Sexes Eligible for Study:
All
Accepts Healthy Volunteers:
Yes
Inclusion Criteria:
  • 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.

Exclusion Criteria:
  • 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.

Contacts and Locations

Locations

Site City State Country Postal Code
1 Mount Sinai Ophthalmology Faculty Practice Associates New York New York United States 10029

Sponsors and Collaborators

  • Icahn School of Medicine at Mount Sinai

Investigators

  • Principal Investigator: James Chelnis, MD, Icahn School of Medicine at Mount Sinai

Study Documents (Full-Text)

None provided.

More Information

Publications

None provided.
Responsible Party:
James Chelnis, Assistant Clinical Professor, Icahn School of Medicine at Mount Sinai
ClinicalTrials.gov Identifier:
NCT04980430
Other Study ID Numbers:
  • Study-20-00358
First Posted:
Jul 28, 2021
Last Update Posted:
Jun 24, 2022
Last Verified:
Jun 1, 2022
Individual Participant Data (IPD) Sharing Statement:
Yes
Plan to Share IPD:
Yes
Studies a U.S. FDA-regulated Drug Product:
No
Studies a U.S. FDA-regulated Device Product:
No
Keywords provided by James Chelnis, Assistant Clinical Professor, Icahn School of Medicine at Mount Sinai

Study Results

No Results Posted as of Jun 24, 2022