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NCT02959593 Clinical Trial

The Effects of Visior on Ocular Hemodynamics

Primary Open Angle Glaucoma Clinical Trial

Official title:
The Effects of Visior on Ocular Hemodynamics

Clinical Trial Details — Status: Completed

Administrative data
NCT number NCT02959593
Other study ID # 1602760177
Secondary ID
Status Completed
Phase N/A
First received
Last updated
Start date January 2017
Est. completion date June 2017

Study information
Verified date August 2018
Source Visior Technologies Ltd.
Contact n/a
Is FDA regulated No
Health authority
Study type Interventional

Clinical 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.

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.

Recruitment information / eligibility
Status Completed
Enrollment 35
Est. completion date June 2017
Est. primary completion date June 2017
Accepts healthy volunteers Accepts Healthy Volunteers
Gender All
Age group 30 Years and older
Eligibility 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.

Study Design

Related Conditions & MeSH terms

Intervention

Device:
• VISIOR video goggles
View commercially available content through the VISIOR video goggles continuously for thirty minutes.

Locations
Country Name City State
United States Eugene and Marilyn Glick Eye Institute, Department of Ophthalmology, Indiana School of Medicine Indianapolis Indiana

Sponsors (2)
Lead Sponsor Collaborator
Visior Technologies Ltd. Indiana University School of Medicine

Country where clinical trial is conducted

United States, 

Outcome
Type Measure Description Time frame Safety issue
Primary retinal capillary blood flow retinal capillary blood flow in arbitrary units 1 day
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