Analysis of Retinal Vessel Pulsations With Electrocardiographic Gating

Not Applicable

Completed

• Conditions: Vessels; Anomaly
• Interventions: Device: Retinal Vessel Analyzer recordings with electrocardiographic (ECG) gating

• Registration Number: NCT04709809
• Lead Sponsor: University Hospital, Basel, Switzerland

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.

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 Timeline

• Study Start: 2017-07-01
• Primary Completion: 2019-06-30
• Study Completion: 2019-06-30
• Status Verified: 2021-01
• Study First Submitted: 2021-01-11
• Study First Submitted QC: 2021-01-13
• Last Update Submitted: 2021-01-13
• Study First Posted: 2021-01-14
• Last Update Posted: 2021-01-14

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 20

Inclusion Criteria

Exclusion Criteria

Known ophthalmological disease, in particular vascular disease.

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: SINGLE_GROUP

Arm && Interventions

Group	Intervention	Description
Experimental arm	Retinal Vessel Analyzer recordings with electrocardiographic (ECG) gating	Measurement RVA / IOP / with ECG gating

Primary Outcome Measures

Name	Time	Method
Phase shift between pulsations	day 1	No phase shift versus phase shift between the venous amplitude maximum and the IOP pulsation maximum.

Trial Locations

Locations (1)

University Eye Hospital; 🇨🇭 Basel, Baseö, Switzerland