Primary Open Angle GlaucomaNCT02959593
The Effects of Visior on Ocular Hemodynamics
A study testing VISIOR video goggles in people with Primary Open Angle Glaucoma, run by Visior Technologies Ltd. at 1 site in United States.
Trial summary
To determine the relationship between the affects of viewing commercially available content through the VISIOR video goggles and ocular blood flow in glaucoma patients and healthy subjects. Read more about this study
- Who is it for?
- Ages 30 years and olderHealthy volunteers can take part
- Conditions the study is for
- Primary Open Angle Glaucoma
- What is being tested?
- VISIOR video goggles
- Type of treatment
- Medical device
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 35 participants
- Where
- 1 siteUnited States
- Study dates
- Jan 2017to Jun 2017
- 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 30 years and older
- All sexes
- Healthy volunteers accepted
- Adult, Older adult
Who may be able to join
- Patients with open-angle glaucoma 30 years or older, free from other ophthalmic disease, free from diabetes, beta agonists and uncontrolled blood pressure.
Who cannot join
- Women who are pregnant or lactating or who plan to become pregnant (self reporting); smoker during last ten years (self reporting); systemic diseases that may interfere with blood flow measurements or wearing the goggles.
- In addition, 10 healthy subjects, age 18 or older, free from eye disease will be enrolled. Identical exclusion criteria apply to this healthy group. Identical procedures apply to this group, which only differs by ocular health status.
Trial locations and contacts
1 site in 1 country.
United States1 site
Eugene and Marilyn Glick Eye Institute, Department of Ophthalmology, Indiana School of Medicine
Indianapolis, Indiana, 46202
About this study
To determine the relationship between the affects of viewing commercially available content through the VISIOR video goggles and ocular blood flow in glaucoma patients and healthy subjects.
Read the detailed description
To determine if glaucoma patients and healthy subject experience any alteration in localized retinal blood flow after retinal stimulation by viewing commercially available content through the VISIOR video goggles.
Both groups will undergo measurements of arterial blood pressure, cardiac pulse (heart rate), intraocular pressure, and retinal blood flow using Heidelberg retinal flowmetry (Heidelberg Engineering, Heidelberg, Germany) at baseline and then ten minutes, thirty minutes, and sixty minutes after viewing commercially available content through the VISIOR video goggles for thirty minutes.
- Conditions
- Primary Open Angle Glaucoma
- Being tested
- VISIOR video goggles
- Keywords
- Primary open-angle glaucoma, retinal capillary blood flow, visual stimulation
- Medical subject headings
- Glaucoma, Open-Angle
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
VISIOR video gogglesDevice
View commercially available content through the VISIOR video goggles continuously for thirty minutes.
| Study group | Role | What they receive |
|---|---|---|
| Glaucoma patients | Experimental | To view commercially available content through the VISIOR video goggles for thirty minutes Receives: Device: VISIOR video goggles |
| Healthy subjects | Experimental | To view commercially available content through the VISIOR video goggles for thirty minutes. Receives: Device: VISIOR video goggles |
What is being measured
The primary outcome is the main question the study is designed to answer.
retinal capillary blood flow
retinal capillary blood flow in arbitrary units
Measured: 1 day
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted9 Nov 2016 (estimated)
- Study startJan 2017
- Primary completionJun 2017
- Study completionJun 2017
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for Primary Open Angle GlaucomaStudies of the same condition, open and under way.
- 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
- Other
- Allocation
- Randomised
- Intervention model
- Single group
- Masking
- Single blind
- Who is masked
- Outcomes assessor
- Enrolment
- 35 participants (actual)
Sponsor and investigators
- Lead sponsor
- Visior Technologies Ltd.
- Sponsor type
- Industry (pharma, biotech, devices)
- Collaborators
- Indiana University
- Responsible party
- Sponsor
- Investigators
- Alon Harris, PhD, Principal investigator, Indiana University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02959593
- Sponsor's protocol ID
- 1602760177
- Status last verified
- Aug 2018
- First submitted
- 1 Nov 2016
- Last updated
- 14 Aug 2018
- Results posted
- No
- Data monitoring committee
- Yes
- Individual data sharing
- No
Publications
Siesky B, Harris A, Gross J, Sechrist E, Camp D, Cardenas A, Patel P, Hasnain F, Kawiecki R, Shah A, Verticchio Vercellin AC. Effects of image brightness and contrast dynamic altering stimuli (DAS) when viewing video content on ocular blood flow. Br J Ophthalmol. 2019 Oct;103(10):1511-1517. doi: 10.1136/bjophthalmol-2018-312561. Epub 2019 Jan 2.
PubMed 30602450
Study at a glance
From the registry record, last updated by the sponsor on 14 Aug 2018. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- The Effects of Visior on Ocular Hemodynamics
- ClinicalTrials.gov ID
- NCT02959593
- Acronym / sponsor ID
- 1602760177
- Conditions
- Primary Open Angle Glaucoma
- Keywords
- Primary open-angle glaucoma, retinal capillary blood flow, visual stimulation
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 35 participants (actual)
- Lead sponsor
- Visior Technologies Ltd.Industry (pharma, biotech, devices)
- Collaborators
- Indiana University
- Study start
- Jan 2017
- Primary completion
- Jun 2017 (actual)
- Study completion
- Jun 2017 (actual)
- First posted
- 9 Nov 2016 (estimated)
- 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.
To determine the relationship between the affects of viewing commercially available content through the VISIOR video goggles and ocular blood flow in glaucoma patients and healthy subjects.
Detailed description
To determine if glaucoma patients and healthy subject experience any alteration in localized retinal blood flow after retinal stimulation by viewing commercially available content through the VISIOR video goggles.
Both groups will undergo measurements of arterial blood pressure, cardiac pulse (heart rate), intraocular pressure, and retinal blood flow using Heidelberg retinal flowmetry (Heidelberg Engineering, Heidelberg, Germany) at baseline and then ten minutes, thirty minutes, and sixty minutes after viewing commercially available content through the VISIOR video goggles for thirty minutes.
Study design
- Primary purpose
- Other
- Allocation
- Randomised
- Intervention model
- Single group
- Masking
- Single blind (outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Glaucoma patients | Experimental | Device: VISIOR video gogglesTo view commercially available content through the VISIOR video goggles for thirty minutes |
| Healthy subjects | Experimental | Device: VISIOR video gogglesTo view commercially available content through the VISIOR video goggles for thirty minutes. |
Who may qualify
- Ages
- 30 years and older
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (1 listed)
- Patients with open-angle glaucoma 30 years or older, free from other ophthalmic disease, free from diabetes, beta agonists and uncontrolled blood pressure.
Key exclusion criteria (2 listed)
- Women who are pregnant or lactating or who plan to become pregnant (self reporting); smoker during last ten years (self reporting); systemic diseases that may interfere with blood flow measurements or wearing the goggles.
- In addition, 10 healthy subjects, age 18 or older, free from eye disease will be enrolled. Identical exclusion criteria apply to this healthy group. Identical procedures apply to this group, which only differs by ocular health status.
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 |
|---|---|---|
| VISIOR video gogglesView commercially available content through the VISIOR video goggles continuously for thirty minutes. | Device | Glaucoma patients, Healthy subjects |
Primary outcome
retinal capillary blood flow
Time frame: 1 day
retinal capillary blood flow in arbitrary units
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 14 Aug 2018.
- Derived from this study: PubMed 30602450Siesky B, Harris A, Gross J, Sechrist E, Camp D, Cardenas A, Patel P, Hasnain F, Kawiecki R, Shah A, Verticchio Vercellin AC. Effects of image brightness and contrast dynamic altering stimuli (DAS) when viewing video content on ocular blood flow. Br J Ophthalmol. 2019 Oct;103(10):1511-1517. doi: 10.1136/bjophthalmol-2018-312561. Epub 2019 Jan 2.
- Individual participant dataSharing planned: No
Related trials for Primary Open Angle Glaucoma
RecruitingPhase 2
A Phase 2a Study Comparing the Efficacy, Safety and Tolerability of Pregabalin Eye Drops Comparing With Timolol Eye Drops in Adults With Glaucoma or High Eye Pressure.
Primary Open - Angle Glaucoma (POAG), Ocular Hypertension (OHT)
Recruiting
The Acute Effect of Exercise Type And Timing on Ambulatory Blood Pressure and Intra-Ocular Pressure in Individuals With Glaucoma (The ACHIEVE-project).
Glaucoma Open-Angle Primary, Hypertension
RecruitingObservational study
PRESERFLO™ MicroShunt XI Observational PMCF Study With no Control Group
Primary Open Angle Glaucoma
Active, not recruitingObservational study
Glaucoma, Visual Field Loss, and Their Association With Life Space in Older Adults
Primary Open Angle Glaucoma
Active, not recruitingObservational study
Impact of Glaucoma and Visual Field Loss on Life Space
Primary Open-angle Glaucoma
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.
Alon Harris, PhD principal investigator
Indiana University
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing VISIOR video goggles in people with Primary Open Angle Glaucoma, run by Visior Technologies Ltd. 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 1 inclusion and 2 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 14 Aug 2018. 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?
retinal capillary blood flow (time frame: 1 day). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT02959593, which also lists 1 linked publication.
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 14 Aug 2018.