The Effects of Visior on Ocular Hemodynamics

Not Applicable

Completed

• Conditions: Primary Open Angle Glaucoma
• Interventions: Device: VISIOR video goggles

• Registration Number: NCT02959593
• Lead Sponsor: 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.

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 Timeline

• Study First Submitted: 2016-11-01
• Study First Submitted QC: 2016-11-07
• Study First Posted: 2016-11-09
• Study Start: 2017-01
• Primary Completion: 2017-06
• Study Completion: 2017-06
• Status Verified: 2018-08
• Last Update Submitted: 2018-08-11
• Last Update Posted: 2018-08-14

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 35

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

• Study Type: INTERVENTIONAL
• Study Design: SINGLE_GROUP

Arm && Interventions

Group	Intervention	Description
Glaucoma patients	VISIOR video goggles	To view commercially available content through the VISIOR video goggles for thirty minutes
Healthy subjects	VISIOR video goggles	To view commercially available content through the VISIOR video goggles for thirty minutes.

Primary Outcome Measures

Name	Time	Method
retinal capillary blood flow	1 day	retinal capillary blood flow in arbitrary units

Trial Locations

Locations (1)

Eugene and Marilyn Glick Eye Institute, Department of Ophthalmology, Indiana School of Medicine; 🇺🇸 Indianapolis, Indiana, United States