The Effects of Visior on Ocular Hemodynamics

NCT ID: NCT02959593

Last Updated: 2018-08-14

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

NA

Total Enrollment

35 participants

Study Classification

INTERVENTIONAL

Study Start Date

2017-01-31

Study Completion Date

2017-06-30

Brief Summary

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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

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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

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Primary Open Angle Glaucoma

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

SINGLE_GROUP

Primary Study Purpose

OTHER

Blinding Strategy

SINGLE

Outcome Assessors

Study Groups

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Glaucoma patients

To view commercially available content through the VISIOR video goggles for thirty minutes

Group Type EXPERIMENTAL

VISIOR video goggles

Intervention Type DEVICE

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

Healthy subjects

To view commercially available content through the VISIOR video goggles for thirty minutes.

Group Type EXPERIMENTAL

VISIOR video goggles

Intervention Type DEVICE

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

Interventions

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VISIOR video goggles

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

Intervention Type DEVICE

Eligibility Criteria

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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.
Minimum Eligible Age

30 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

Yes

Sponsors

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Indiana University School of Medicine

OTHER

Sponsor Role collaborator

Visior Technologies Ltd.

INDUSTRY

Sponsor Role lead

Responsible Party

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Responsibility Role SPONSOR

Principal Investigators

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Alon Harris, PhD

Role: PRINCIPAL_INVESTIGATOR

Indiana University School of Medicine

Locations

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Eugene and Marilyn Glick Eye Institute, Department of Ophthalmology, Indiana School of Medicine

Indianapolis, Indiana, United States

Site Status

Countries

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United States

References

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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.

Reference Type DERIVED
PMID: 30602450 (View on PubMed)

Other Identifiers

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1602760177

Identifier Type: -

Identifier Source: org_study_id

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