Back to resultsThe Effects of Visior on Ocular Hemodynamics
Primary Purpose
Primary Open Angle Glaucoma
Status
Completed
Phase
Not Applicable
Locations
United States
Study Type
Interventional
Intervention
VISIOR video goggles
Sponsored by
About this trial
This is an interventional other trial for Primary Open Angle Glaucoma focused on measuring Primary open-angle glaucoma, retinal capillary blood flow, visual stimulation
Eligibility Criteria
Inclusion Criteria:
- Patients with open-angle glaucoma 30 years or older, free from other ophthalmic disease, free from diabetes, beta agonists and uncontrolled blood pressure.
Exclusion Criteria:
- 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.
Sites / Locations
- Eugene and Marilyn Glick Eye Institute, Department of Ophthalmology, Indiana School of Medicine
Arms of the Study
Arm 1
Arm 2
Arm Type
Experimental
Experimental
Arm Label
Glaucoma patients
Healthy subjects
Arm Description
To view commercially available content through the VISIOR video goggles for thirty minutes
To view commercially available content through the VISIOR video goggles for thirty minutes.
Outcomes
Primary Outcome Measures
retinal capillary blood flow
retinal capillary blood flow in arbitrary units
Secondary Outcome Measures
Full Information
NCT ID
NCT02959593
First Posted
November 1, 2016
Last Updated
August 11, 2018
Sponsor
Visior Technologies Ltd.
Collaborators
Indiana University School of Medicine
1. Study Identification
Unique Protocol Identification Number
NCT02959593
Brief Title
The Effects of Visior on Ocular Hemodynamics
Official Title
The Effects of Visior on Ocular Hemodynamics
Study Type
Interventional
2. Study Status
Record Verification Date
August 2018
Overall Recruitment Status
Completed
Study Start Date
January 2017 (undefined)
Primary Completion Date
June 2017 (Actual)
Study Completion Date
June 2017 (Actual)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Visior Technologies Ltd.
Collaborators
Indiana University School of Medicine
4. Oversight
Data Monitoring Committee
Yes
5. Study Description
Brief 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.
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.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Primary Open Angle Glaucoma
Keywords
Primary open-angle glaucoma, retinal capillary blood flow, visual stimulation
7. Study Design
Primary Purpose
Other
Study Phase
Not Applicable
Interventional Study Model
Single Group Assignment
Masking
Outcomes Assessor
Allocation
Randomized
Enrollment
35 (Actual)
8. Arms, Groups, and Interventions
Arm Title
Glaucoma patients
Arm Type
Experimental
Arm Description
To view commercially available content through the VISIOR video goggles for thirty minutes
Arm Title
Healthy subjects
Arm Type
Experimental
Arm Description
To view commercially available content through the VISIOR video goggles for thirty minutes.
Intervention Type
Device
Intervention Name(s)
VISIOR video goggles
Intervention Description
View commercially available content through the VISIOR video goggles continuously for thirty minutes.
Primary Outcome Measure Information:
Title
retinal capillary blood flow
Description
retinal capillary blood flow in arbitrary units
Time Frame
1 day
10. Eligibility
Sex
All
Minimum Age & Unit of Time
30 Years
Accepts Healthy Volunteers
Accepts Healthy Volunteers
Eligibility Criteria
Inclusion Criteria:
Patients with open-angle glaucoma 30 years or older, free from other ophthalmic disease, free from diabetes, beta agonists and uncontrolled blood pressure.
Exclusion Criteria:
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.
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Alon Harris, PhD
Organizational Affiliation
Indiana University School of Medicine
Official's Role
Principal Investigator
Facility Information:
Facility Name
Eugene and Marilyn Glick Eye Institute, Department of Ophthalmology, Indiana School of Medicine
City
Indianapolis
State/Province
Indiana
ZIP/Postal Code
46202
Country
United States
12. IPD Sharing Statement
Plan to Share IPD
No
Citations:
PubMed Identifier
30602450
Citation
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.
Results Reference
derived
Learn more about this trial
The Effects of Visior on Ocular Hemodynamics
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