ClinicalTrials.gov
ClinicalTrials.gov Menu

The Effects of Visior on Ocular Hemodynamics

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
ClinicalTrials.gov Identifier: NCT02959593
Recruitment Status : Completed
First Posted : November 9, 2016
Last Update Posted : August 14, 2018
Sponsor:
Collaborator:
Indiana University School of Medicine
Information provided by (Responsible Party):
Visior Technologies Ltd.

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.

Condition or disease Intervention/treatment Phase
Primary Open Angle Glaucoma Device: VISIOR video goggles Not Applicable

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 Type : Interventional  (Clinical Trial)
Actual Enrollment : 35 participants
Allocation: Randomized
Intervention Model: Single Group Assignment
Masking: Single (Outcomes Assessor)
Primary Purpose: Other
Official Title: The Effects of Visior on Ocular Hemodynamics
Study Start Date : January 2017
Actual Primary Completion Date : June 2017
Actual Study Completion Date : June 2017

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Glaucoma

Arm Intervention/treatment
Experimental: Glaucoma patients
To view commercially available content through the VISIOR video goggles for thirty minutes
Device: VISIOR video goggles
View commercially available content through the VISIOR video goggles continuously for thirty minutes.

Experimental: Healthy subjects
To view commercially available content through the VISIOR video goggles for thirty minutes.
Device: VISIOR video goggles
View commercially available content through the VISIOR video goggles continuously for thirty minutes.




Primary Outcome Measures :
  1. retinal capillary blood flow [ Time Frame: 1 day ]
    retinal capillary blood flow in arbitrary units



Information from the National Library of Medicine

Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the contacts provided below. For general information, Learn About Clinical Studies.


Ages Eligible for Study:   30 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   Yes
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.

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT02959593


Locations
United States, Indiana
Eugene and Marilyn Glick Eye Institute, Department of Ophthalmology, Indiana School of Medicine
Indianapolis, Indiana, United States, 46202
Sponsors and Collaborators
Visior Technologies Ltd.
Indiana University School of Medicine
Investigators
Principal Investigator: Alon Harris, PhD Indiana University School of Medicine

Publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):
Responsible Party: Visior Technologies Ltd.
ClinicalTrials.gov Identifier: NCT02959593     History of Changes
Other Study ID Numbers: 1602760177
First Posted: November 9, 2016    Key Record Dates
Last Update Posted: August 14, 2018
Last Verified: August 2018
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No

Keywords provided by Visior Technologies Ltd.:
Primary open-angle glaucoma
retinal capillary blood flow
visual stimulation

Additional relevant MeSH terms:
Glaucoma
Glaucoma, Open-Angle
Ocular Hypertension
Eye Diseases