Clinical trial NCT04980430: Community Interest in Vision Screening Technology
Official title: Evaluating Community Interest in Virtual Reality Vision Screening Technology
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Ophthalmology
Vision Screening
Keywords: Ophthalmology
Virtual Reality
Community
Vision
Lead sponsor: Icahn School of Medicine at Mount Sinai
Sponsor class: OTHER
First posted: 2021-07-28
Enrollment: 1000
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Observational model: OTHER
Time perspective: PROSPECTIVE
Sampling method: NON_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.

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.

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.

Eligibility criteria: 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.

Primary outcomes:
measure: Virtual Reality Assessment
timeFrame: Day 1
Secondary outcomes:
measure: Demographics Assessment
timeFrame: Day 1
Other outcomes:
Locations:
city: New York
country: United States
facility: Mount Sinai Ophthalmology Faculty Practice Associates
state: New York
Study officials:
affiliation: Icahn School of Medicine at Mount Sinai
name: James Chelnis, MD
role: PRINCIPAL_INVESTIGATOR
References: