OphthalmologyRTS2NCT04980430
Community Interest in Vision Screening Technology
An observational study of Ophthalmology and Vision Screening, run by Icahn School of Medicine at Mount Sinai at 1 site in United States.
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. Read more about this study
- Who is it for?
- Ages 18 years and olderHealthy volunteers can take part
- Conditions the study is for
- Ophthalmology, Vision Screening
- What is being tested?
- Virtual Reality
- Type of treatment
- Medical device
- How many people
- 1,000 participants
- Where
- 1 siteUnited States
- Study dates
- 1 Oct 2020to 20 Oct 2022
- Phase
- Observational
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- Healthy volunteers accepted
- Adult, Older adult
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.
Who may be able to join
- 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.
Who cannot join
- 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.
Trial locations and contacts
1 site in 1 country.
United States1 site
Mount Sinai Ophthalmology Faculty Practice Associates
New York, New York, 10029
About this study
Official title: Evaluating Community Interest in Virtual Reality Vision Screening Technology
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.
Read the 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.
- Conditions
- Ophthalmology, Vision Screening
- Being tested
- Virtual Reality
- Keywords
- Ophthalmology, Virtual Reality, Community, Vision
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Virtual RealityDevice
Virtual Reality Demonstration
| Study group | Role | What they receive |
|---|---|---|
| Primary Care and Ophthalmology clinic patients | Participants will be recruited from primary care and ophthalmology clinics in New York City Receives: Device: Virtual Reality |
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: Day 1
Secondary outcomes (1)
Demographics Assessment
Survey to evaluate participant demographics and vision care needs. This is not a scored or scaled survey.
Measured: Day 1
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted28 Jul 2021
- Study start1 Oct 2020
- Primary completion20 Oct 2022
- Study completion20 Oct 2022
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for OphthalmologyStudies of the same condition, open and under way.
- More trials run by Icahn School of Medicine at Mount SinaiThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Other
- Time perspective
- Prospective
- Enrolment
- 1,000 participants (actual)
Sponsor and investigators
- Lead sponsor
- Icahn School of Medicine at Mount Sinai
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, James Chelnis, Icahn School of Medicine at Mount Sinai
- Investigators
- James Chelnis, MD, Principal investigator, Icahn School of Medicine at Mount Sinai
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04980430
- Sponsor's protocol ID
- Study-20-00358
- Acronym
- RTS2
- Status last verified
- Aug 2024
- First submitted
- 18 Jul 2021
- Last updated
- 28 Aug 2024
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Yes: All of the individual participant data collected during the trial, after deidentification.
Study at a glance
From the registry record, last updated by the sponsor on 28 Aug 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Evaluating Community Interest in Virtual Reality Vision Screening Technology
- ClinicalTrials.gov ID
- NCT04980430
- Acronym / sponsor ID
- RTS2 / Study-20-00358
- Conditions
- Ophthalmology, Vision Screening
- Keywords
- Ophthalmology, Virtual Reality, Community, Vision
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 1,000 participants (actual)
- Lead sponsor
- Icahn School of Medicine at Mount SinaiUniversity, hospital or other
- Study start
- 1 Oct 2020 (actual)
- Primary completion
- 20 Oct 2022 (actual)
- Study completion
- 20 Oct 2022 (actual)
- First posted
- 28 Jul 2021 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Observational model
- Other
- Time perspective
- Prospective
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Primary Care and Ophthalmology clinic patients | – | Device: Virtual RealityParticipants will be recruited from primary care and ophthalmology clinics in New York City |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
- 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.
Key inclusion criteria (3 listed)
- 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.
Key exclusion criteria (1 listed)
- 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.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Virtual RealityVirtual Reality Demonstration | Device | Primary Care and Ophthalmology clinic patients |
Primary outcome
Virtual Reality Assessment
Time frame: 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.
1 secondary outcome
Demographics Assessment
Time frame: Day 1
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 28 Aug 2024.
- Individual participant dataSharing planned: Yes. All of the individual participant data collected during the trial, after deidentification.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
James Chelnis, MD principal investigator
Icahn School of Medicine at Mount Sinai
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Ophthalmology and Vision Screening, run by Icahn School of Medicine at Mount Sinai at 1 site in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 3 inclusion and 1 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 28 Aug 2024. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Virtual Reality Assessment (time frame: Day 1). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 28 Aug 2024.