Analysis of Retinal Vessel Pulsations With Electrocardiographic Gating

Vessels; Anomaly Clinical Trial

Official title:

Analysis of Retinal Vessel Pulsations With Electrocardiographic Gating

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT04709809
• Other study ID #: 2017-01036
• Status: Completed
• Phase: N/A
• Start date: July 1, 2017
• Est. completion date: June 30, 2019

Study information

• Verified date: January 2021
• Source: University Hospital, Basel, Switzerland
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 20
• Est. completion date: June 30, 2019
• Est. primary completion date: June 30, 2019
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: All
• Age group: 20 Years to 35 Years

Eligibility

Inclusion Criteria:

-

Exclusion Criteria:

Known ophthalmological disease, in particular vascular disease.

Related Conditions & MeSH terms

• Vessels; Anomaly

Intervention

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.

Locations

Country	Name	City	State
Switzerland	University Eye Hospital	Basel	Baseö

Sponsors (1)

Lead Sponsor	Collaborator
University Hospital, Basel, Switzerland

Country where clinical trial is conducted

Switzerland, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Phase shift between pulsations	No phase shift versus phase shift between the venous amplitude maximum and the IOP pulsation maximum.	day 1