Analysis of Retinal Vessel Pulsations With Electrocardiographic Gating

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.

Study Overview

• Status: Completed
• Conditions: Vessels; Anomaly
• Intervention / Treatment: Device: Retinal Vessel Analyzer recordings with electrocardiographic (ECG) gating

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 Type: Interventional
• Enrollment (Actual): 20
• Phase: Not Applicable

Contacts and Locations

Study Locations

• Switzerland
  • Baseö
    • Basel, Baseö, Switzerland, 4031
      • University Eye Hospital

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 20 years to 35 years (Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

Description

Inclusion Criteria:

-

Exclusion Criteria:

Known ophthalmological disease, in particular vascular disease.

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Diagnostic
• Allocation: N/A
• Interventional Model: Single Group Assignment
• Masking: None (Open Label)

Number of Arms

1

Arms and Interventions

Participant Group / 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.

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Phase shift between pulsations	No phase shift versus phase shift between the venous amplitude maximum and the IOP pulsation maximum.	day 1

Collaborators and Investigators

• Sponsor: University Hospital, Basel, Switzerland

Study record dates

Study Major Dates

• Study Start (Actual): July 1, 2017
• Primary Completion (Actual): June 30, 2019
• Study Completion (Actual): June 30, 2019

Study Registration Dates

• First Submitted: January 11, 2021
• First Submitted That Met QC Criteria: January 13, 2021
• First Posted (Actual): January 14, 2021

Study Record Updates

• Last Update Posted (Actual): January 14, 2021
• Last Update Submitted That Met QC Criteria: January 13, 2021
• Last Verified: January 1, 2021

More Information

Terms related to this study

• Other Study ID Numbers: 2017-01036

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: No

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No