NCT02959593

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.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
35

participants targeted

Target at P25-P50 for not_applicable

Timeline
Completed

Started Jan 2017

Shorter than P25 for not_applicable

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

November 1, 2016

Completed
8 days until next milestone

First Posted

Study publicly available on registry

November 9, 2016

Completed
2 months until next milestone

Study Start

First participant enrolled

January 1, 2017

Completed
5 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

June 1, 2017

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

June 1, 2017

Completed
Last Updated

August 14, 2018

Status Verified

August 1, 2018

Enrollment Period

5 months

First QC Date

November 1, 2016

Last Update Submit

August 11, 2018

Conditions

Keywords

Primary open-angle glaucomaretinal capillary blood flowvisual stimulation

Outcome Measures

Primary Outcomes (1)

  • retinal capillary blood flow

    retinal capillary blood flow in arbitrary units

    1 day

Study Arms (2)

Glaucoma patients

EXPERIMENTAL

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

Device: VISIOR video goggles

Healthy subjects

EXPERIMENTAL

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

Device: VISIOR video goggles

Interventions

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

Glaucoma patientsHealthy subjects

Eligibility Criteria

Age30 Years+
Sexall
Healthy VolunteersYes
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • Patients with open-angle glaucoma 30 years or older, free from other ophthalmic disease, free from diabetes, beta agonists and uncontrolled blood pressure.

You may not qualify if:

  • 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.

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

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

Indianapolis, Indiana, 46202, United States

Location

Related Publications (1)

  • 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.

MeSH Terms

Conditions

Glaucoma, Open-Angle

Condition Hierarchy (Ancestors)

GlaucomaOcular HypertensionEye Diseases

Study Officials

  • Alon Harris, PhD

    Indiana University School of Medicine

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
SINGLE
Who Masked
OUTCOMES ASSESSOR
Purpose
OTHER
Intervention Model
SINGLE GROUP
Sponsor Type
INDUSTRY
Responsible Party
SPONSOR

Study Record Dates

First Submitted

November 1, 2016

First Posted

November 9, 2016

Study Start

January 1, 2017

Primary Completion

June 1, 2017

Study Completion

June 1, 2017

Last Updated

August 14, 2018

Record last verified: 2018-08

Data Sharing

IPD Sharing
Will not share

Locations