NCT04709809

Brief Summary

Analysis of Retinal Vessel Analyzer (RVA) recordings of retinal vessel pulsations, and putting them in context of intraocular pressure (IOP) pulsations by means of electrocardiographic (ECG) gating, in order to determine the lead source for pulsations of retinal veins.

Trial Health

87
On Track

Trial Health Score

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

Enrollment
20

participants targeted

Target at below P25 for not_applicable

Timeline
Completed

Started Jul 2017

Typical duration 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

Study Start

First participant enrolled

July 1, 2017

Completed
2 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

June 30, 2019

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

June 30, 2019

Completed
1.5 years until next milestone

First Submitted

Initial submission to the registry

January 11, 2021

Completed
3 days until next milestone

First Posted

Study publicly available on registry

January 14, 2021

Completed
Last Updated

January 14, 2021

Status Verified

January 1, 2021

Enrollment Period

2 years

First QC Date

January 11, 2021

Last Update Submit

January 13, 2021

Conditions

Vessels; Anomaly

Outcome Measures

Primary Outcomes (1)

  • Phase shift between pulsations

    No phase shift versus phase shift between the venous amplitude maximum and the IOP pulsation maximum.

    day 1

Study Arms (1)

Experimental arm

EXPERIMENTAL

Measurement RVA / IOP / with ECG gating

Device: Retinal Vessel Analyzer recordings with electrocardiographic (ECG) gating

Interventions

Retinal Vessel Analyzer recordings with electrocardiographic (ECG) gatingDEVICE

Video recordings of ocular fundus, an analysis of dynamic vessel diameters and putting them in ECG context.

Experimental arm

Eligibility Criteria

Age20 Years - 35 Years
Sexall
Healthy VolunteersYes
Age GroupsAdult (18-64)

You may not qualify if:

  • Known ophthalmological disease, in particular vascular disease.

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

University Eye Hospital

Basel, Baseö, 4031, Switzerland

Location

MeSH Terms

Conditions

Congenital Abnormalities

Interventions

Electrocardiography

Condition Hierarchy (Ancestors)

Congenital, Hereditary, and Neonatal Diseases and Abnormalities

Intervention Hierarchy (Ancestors)

Heart Function TestsDiagnostic Techniques, CardiovascularDiagnostic Techniques and ProceduresDiagnosisElectrodiagnosis

Study Design

Study Type
interventional
Phase
not applicable
Allocation
NA
Masking
NONE
Purpose
DIAGNOSTIC
Intervention Model
SINGLE GROUP
Model Details: Data driven analysis
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

January 11, 2021

First Posted

January 14, 2021

Study Start

July 1, 2017

Primary Completion

June 30, 2019

Study Completion

June 30, 2019

Last Updated

January 14, 2021

Record last verified: 2021-01

Data Sharing

IPD Sharing
Will not share

Locations

CH(1)