Analysis of Retinal Vessel Pulsations With Electrocardiographic Gating

Sponsor

University Hospital, Basel, Switzerland (Other)

Overall Status

Completed

CT.gov ID

NCT04709809

Collaborator

(none)

Enrollment

Location

Arm

Actual Duration (Months)

0.8

Patients Per Site Per Month

Study Details

Study Description

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.

Condition or Disease	Intervention/Treatment	Phase
Vessels; Anomaly	Device: Retinal Vessel Analyzer recordings with electrocardiographic (ECG) gating	N/A

Detailed Description

Rationale / Objective is to construct the retinal vessels wall pulsation cycle using an electrocardiographic gating, and to analyse it in comparison with an analogue intraocular pressure (IOP) cycle.

Based on the amplitude and on the phase shift of pulsations of retinal vessel wall, the goal is to identify a lead source of the retinal venous pulsations (IOP pulsations, or alternative sources, e.g. cerebrospinal fluid pulsations).

Subjects will be recruited from the environment of the master thesis medical students, colleagues and friends and the informed consent will be handed to them personally. Exclusion criteria will be addressed. One random eye per subject will be selected. On the study day, first the mydriasis drops - phenylephrine + tropicamide - will be applied, then ECG electrodes attached; 20 minutes after the mydriasis drops, the first set of measurements will be performed: RVA recording with ECG gating, and Pascal Dynamic Contour Tonometry (DCT) recording with ECG gating. Ten minutes after this measurements, 100% oxygen 5 liters/min through nasal cannula will be applied for 2 minutes and then the same measurements repeated. Approximate time needed for the whole run - around 60 minutes per subject, including (dis)mounting the ECG electrodes and the mydriasis time.

Study Design

Study Type:

Interventional

Actual Enrollment :

20 participants

Allocation:

N/A

Intervention Model:

Single Group Assignment

Intervention Model Description:

Data driven analysisData driven analysis

Masking:

None (Open Label)

Primary Purpose:

Diagnostic

Official Title:

Analysis of Retinal Vessel Pulsations With Electrocardiographic Gating

Actual Study Start Date :

Jul 1, 2017

Actual Primary Completion Date :

Jun 30, 2019

Actual Study Completion Date :

Jun 30, 2019

Arms and Interventions

Arm	Intervention/Treatment
Experimental: Experimental arm Measurement RVA / IOP / with ECG gating	Device: Retinal Vessel Analyzer recordings with electrocardiographic (ECG) gating Video recordings of ocular fundus, an analysis of dynamic vessel diameters and putting them in ECG context.

Arm

Intervention/Treatment

Experimental: Experimental arm

Measurement RVA / IOP / with ECG gating

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

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

Outcome Measures

Primary Outcome Measures

Phase shift between pulsations [day 1]
No phase shift versus phase shift between the venous amplitude maximum and the IOP pulsation maximum.

Eligibility Criteria

Criteria

Ages Eligible for Study:

20 Years to 35 Years

Sexes Eligible for Study:

All

Accepts Healthy Volunteers:

Yes

Inclusion Criteria:

Exclusion Criteria:

Known ophthalmological disease, in particular vascular disease.

Contacts and Locations

Locations

	Site	City	State	Country	Postal Code
1	University Eye Hospital	Basel	Baseö	Switzerland	4031

Sponsors and Collaborators

University Hospital, Basel, Switzerland

Investigators

None specified.

Study Documents (Full-Text)

None provided.

More Information

Publications

None provided.

Responsible Party:

University Hospital, Basel, Switzerland

ClinicalTrials.gov Identifier:

NCT04709809

Other Study ID Numbers:

2017-01036

First Posted:

Jan 14, 2021

Last Update Posted:

Jan 14, 2021

Last Verified:

Jan 1, 2021

Individual Participant Data (IPD) Sharing Statement:

Plan to Share IPD:

Studies a U.S. FDA-regulated Drug Product:

Studies a U.S. FDA-regulated Device Product:

Study Results

No Results Posted as of Jan 14, 2021