Visual ImpairmentNCT05135195
A Virtual Reality Platform Simulating Visual Impairment for Testing of Electronic Travel Aids and Performing Orientation and Mobility Training
A study testing In-House Developed VR Platform - AMD, DR, Glaucoma and In-House Developed VR Platform - Glaucoma in people with Visual Impairment and Age-Related Macular Degeneration, run by NYU Langone Health at 1 site in United States.
Trial summary
In this study, the study team utilize virtual reality (VR) to simulate visual impairments of different types and severity in healthy subjects. The platform implements three of the most widespread forms of visual impairment in the United States (US): age-related macular degeneration (AMD), diabetic retinopathy (DR)… Read more about this study
- Who is it for?
- Ages 18 to 80 yearsHealthy volunteers can take part
- Conditions the study is for
- Visual Impairment, Age-Related Macular Degeneration, Diabetic Retinopathy
- What is being tested?
- In-House Developed VR Platform - AMD, DR, Glaucoma and In-House Developed VR Platform - Glaucoma
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 98 participants
- Where
- 1 siteUnited States
- Study dates
- 24 Oct 2021to 20 Oct 2022
- Phase
- Interventional
- 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 to 80 years
- All sexes
- Healthy volunteers accepted
- Adult, Older adult
Who may be able to join
- Aged 18-80;
- People with glaucoma of all different levels and etiologies.
- Aged 18-80;
- Gender neutral: male or female.
- Exclusion Criteria (patients with visual impairment \& healthy controls)
- Significant cognitive dysfunction (score <24 on Folsteins' Mini Mental Status Examination)
Show all 12Show fewer
- Previous neurological illness or psychiatric disorders, or suffer from a heart condition or other serious medical conditions
- Significant mobility restrictions; people using walkers and wheelchairs
- Pregnancy
- Elderly
- Seizures (people who previously have had a seizure, loss of awareness, or other symptom linked to an epileptic condition)
- Interference with medical devices (the headset and controller(s) may contain magnets or components that emit radio waves, which could affect the operation of nearby electronics, including cardiac pacemakers, hearing aids, and defibrillators)
Who cannot join
None listed.
Trial locations and contacts
1 site in 1 country.
About this study
In this study, the study team utilize virtual reality (VR) to simulate visual impairments of different types and severity in healthy subjects. The platform implements three of the most widespread forms of visual impairment in the United States (US): age-related macular degeneration (AMD), diabetic retinopathy (DR), and glaucoma, each with three levels of severity, (mild, moderate, and severe). At present, glaucoma is further developed toward a multidimensional visual impairment simulation.
The platform is utilized: i) to provide a safe, controllable, and repeatable set of environments for development and preliminary testing of electronic travel aids (ETAs) in a variety of conditions (i.e., using the ETA to navigate in the immersed environment); and ii) to equip blind and low vision (BVI) professionals, inclusive of orientation and mobility (O\&M) instructors, with a controlled, tunable training platform for skill/capacity building, assessment, and refinement of O\&M techniques, as well as visually impaired trainees with a safe and immersive environment to improve their O\&M skills and learn novel techniques. Two sets of hypothesis-driven experiments are proposed to assess the feasibility of the platform with respect to these two objectives.
- Being tested
- In-House Developed VR Platform - AMD, DR, Glaucoma, In-House Developed VR Platform - Glaucoma
- Medical subject headings
- Vision Disorders, Macular Degeneration, Diabetic Retinopathy, Glaucoma
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
In-House Developed VR Platform - AMD, DR, GlaucomaOther
Participants will conduct experiments using commercial VR headsets and controllers. Visual impairments will be systematically simulated in VR. There are three visual impairment simulations (AMD, DR, and glaucoma) at three levels of severity (mild, moderate, or severe). Symptoms' simulation tools include a gaussian blur shader, distortion shader, and a culling mask with a gray spot in the middle.
In-House Developed VR Platform - GlaucomaOther
In the second set of experiments, a multidimensional visual impairment simulation of a single pathology (glaucoma) will be used at three levels of severity (mild, moderate, or severe). The post-processing package to simulate includes glare, difficulty in light, change adaptation, ambient occlusion, visual clutter, and overall blurred effect. The shader graph package will be used to create a distortion localized on assets surfaces only.
| Study group | Role | What they receive |
|---|---|---|
| First Set of Experiments | Experimental | The anticipated number of participants is 336. All participants have healthy vision. Receives: Other: In-House Developed VR Platform - AMD, DR, Glaucoma |
| Second Set of Experiments | Experimental | The anticipated number of participants is 100. Of these, 80 participants have healthy vision, and 20 have glaucoma. Receives: Other: In-House Developed VR Platform - Glaucoma |
What is being measured
The primary outcome is the main question the study is designed to answer.
Average time to complete the trial
Measured: 1 Day of Intervention
Average number of obstacle collisions during the trial
Measured: 1 Day of Intervention
Average travel time
Measured: 1 Day of Intervention
Average distance traveled by the participant
Measured: 1 Day of Intervention
Preferred walking speed
Measured: 1 Day of Intervention
Orientation
Orientation is measured through the time average of a polarization index, measured as the cosin of the angle between the direction of the instantaneous velocity vector and the straight line linking the instantaneous position of the participant and the following waypoint.
Measured: 1 Day of Intervention
Number of instances in which the participant stop for more than 2 seconds
Measured: 1 Day of Intervention
Total time spent during stops of more than 2 seconds
Measured: 1 Day of Intervention
Average time it takes to understand how to interact with the system and run the simulation of the bus ride
Measured: 1 Day of Intervention
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted26 Nov 2021
- Study start24 Oct 2021
- 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 Visual ImpairmentStudies of the same condition, open and under way.
- More trials run by NYU Langone HealthThe 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
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Screening
- Allocation
- Non-randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 98 participants (actual)
Sponsor and investigators
- Lead sponsor
- NYU Langone Health
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- John-Ross Rizzo, MD, Principal investigator, NYU Langone Health
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05135195
- Sponsor's protocol ID
- 21-00925
- Status last verified
- Jun 2023
- First submitted
- 17 Nov 2021
- Last updated
- 3 Jul 2023
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Yes: Individual participant data that underlie the results reported in this article, after deidentification (text, tables, figures, and appendices) will be available upon reasonable request.
Study at a glance
From the registry record, last updated by the sponsor on 3 Jul 2023. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Virtual Reality Platform Simulating Visual Impairment for Testing of Electronic Travel Aids and Performing Orientation and Mobility Training
- ClinicalTrials.gov ID
- NCT05135195
- Acronym / sponsor ID
- 21-00925
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 98 participants (actual)
- Lead sponsor
- NYU Langone HealthUniversity, hospital or other
- Study start
- 24 Oct 2021 (actual)
- Primary completion
- 20 Oct 2022 (actual)
- Study completion
- 20 Oct 2022 (actual)
- First posted
- 26 Nov 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.
In this study, the study team utilize virtual reality (VR) to simulate visual impairments of different types and severity in healthy subjects. The platform implements three of the most widespread forms of visual impairment in the United States (US): age-related macular degeneration (AMD), diabetic retinopathy (DR), and glaucoma, each with three levels of severity, (mild, moderate, and severe). At present, glaucoma is further developed toward a multidimensional visual impairment simulation.
The platform is utilized: i) to provide a safe, controllable, and repeatable set of environments for development and preliminary testing of electronic travel aids (ETAs) in a variety of conditions (i.e., using the ETA to navigate in the immersed environment); and ii) to equip blind and low vision (BVI) professionals, inclusive of orientation and mobility (O\&M) instructors, with a controlled, tunable training platform for skill/capacity building, assessment, and refinement of O\&M techniques, as well as visually impaired trainees with a safe and immersive environment to improve their O\&M skills and learn novel techniques. Two sets of hypothesis-driven experiments are proposed to assess the feasibility of the platform with respect to these two objectives.
Study design
- Primary purpose
- Screening
- Allocation
- Non-randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| First Set of Experiments | Experimental | Other: In-House Developed VR Platform - AMD, DR, GlaucomaThe anticipated number of participants is 336. All participants have healthy vision. |
| Second Set of Experiments | Experimental | Other: In-House Developed VR Platform - GlaucomaThe anticipated number of participants is 100. Of these, 80 participants have healthy vision, and 20 have glaucoma. |
Who may qualify
- Ages
- 18 to 80 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (12 listed)
- Aged 18-80;
- People with glaucoma of all different levels and etiologies.
- Aged 18-80;
- Gender neutral: male or female.
- Exclusion Criteria (patients with visual impairment \& healthy controls)
Key exclusion criteria (0 listed)
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 |
|---|---|---|
| In-House Developed VR Platform - AMD, DR, GlaucomaParticipants will conduct experiments using commercial VR headsets and controllers. Visual impairments will be systematically simulated in VR. There are three visual impairment simulations (AMD, DR, and glaucoma) at three levels of severity (mild, moderate, or severe). Symptoms' simulation tools include a gaussian blur shader, distortion shader, and a culling mask with a gray spot in the middle. | Other | First Set of Experiments |
| In-House Developed VR Platform - GlaucomaIn the second set of experiments, a multidimensional visual impairment simulation of a single pathology (glaucoma) will be used at three levels of severity (mild, moderate, or severe). The post-processing package to simulate includes glare, difficulty in light, change adaptation, ambient occlusion, visual clutter, and overall blurred effect. The shader graph package will be used to create a distortion localized on assets surfaces only. | Other | Second Set of Experiments |
Primary outcome
Average time to complete the trial
Time frame: 1 Day of Intervention
Average number of obstacle collisions during the trial
Time frame: 1 Day of Intervention
Average travel time
Time frame: 1 Day of Intervention
Average distance traveled by the participant
Time frame: 1 Day of Intervention
Preferred walking speed
Time frame: 1 Day of Intervention
Orientation
Time frame: 1 Day of Intervention
Orientation is measured through the time average of a polarization index, measured as the cosin of the angle between the direction of the instantaneous velocity vector and the straight line linking the instantaneous position of the participant and the following waypoint.
Number of instances in which the participant stop for more than 2 seconds
Time frame: 1 Day of Intervention
Total time spent during stops of more than 2 seconds
Time frame: 1 Day of Intervention
Average time it takes to understand how to interact with the system and run the simulation of the bus ride
Time frame: 1 Day of Intervention
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 3 Jul 2023.
- Individual participant dataSharing planned: Yes. Individual participant data that underlie the results reported in this article, after deidentification (text, tables, figures, and appendices) will be available upon reasonable request.
Related trials for Visual Impairment
Not yet recruiting
joyVision: The Superiority of Co-design in the Development of a Serious Game for Children With Cerebral Visual Impairment
Cerebral Visual Impairment
Not yet recruitingPhase 4
Iopidine to Decrease Intraocular Pressure Rise After Injections
Macular Degeneration, Diabetic Retinopathy
RecruitingPhase 1
A Study About the Safety of a Single ASP2020 Eye Injection and if it Helps People With Vision Loss From Stargardt-type Eye Conditions
Stargardt Disease, Stargardt Macular Dystrophy
RecruitingPhase 3
Intravitreal Faricimab Injections or Fluocinolone Acetonide (0.19 mg) Intravitreal Implants vs Observation for Prevention of VA Loss Due to Radiation Retinopathy
Radiation Retinopathy, Visual Impairment
Recruiting
Leveraging Artificial Intelligence to Prevent Vision Loss From Diabetes
Diabetic Retinopathy, Diabetes Mellitus
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.
John-Ross Rizzo, MD principal investigator
NYU Langone Health
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing In-House Developed VR Platform - AMD, DR, Glaucoma and In-House Developed VR Platform - Glaucoma in people with Visual Impairment and Age-Related Macular Degeneration, run by NYU Langone Health 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 12 inclusion and 0 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 3 Jul 2023. 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?
Average time to complete the trial (time frame: 1 Day of Intervention). The study lists 9 primary outcomes in all. 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 3 Jul 2023.