Community Interest in Vision Screening Technology

Ophthalmology Clinical Trial

— RTS2  

Official title:

Evaluating Community Interest in Virtual Reality Vision Screening Technology

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT04980430
• Other study ID #: Study-20-00358
• Status: Recruiting
• Start date: June 1, 2021
• Est. completion date: August 2023

Study information

• Verified date: June 2022
• Source: Icahn School of Medicine at Mount Sinai
• Contact: Margarita Labkovich, BA
• Phone: 929-464-6970
• Email: VReyecare[@]gmail.com
• Is FDA regulated: No
• Study type: Observational

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 1000
• Est. completion date: August 2023
• Est. primary completion date: August 2023
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: All
• Age group: 18 Years and older

Eligibility

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.

Related Conditions & MeSH terms

• Ophthalmology

Intervention

Device:
• Virtual Reality
Virtual Reality Demonstration

Locations

Country	Name	City	State
United States	Mount Sinai Ophthalmology Faculty Practice Associates	New York	New York

Sponsors (1)

Lead Sponsor	Collaborator
Icahn School of Medicine at Mount Sinai

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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	Demographics Assessment	Survey to evaluate participant demographics and vision care needs. This is not a scored or scaled survey.	Day 1