Analysis of Retinal Vessel Pulsations With Electrocardiographic Gating

NCT ID: NCT04709809

Last Updated: 2021-01-14

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

NA

Total Enrollment

20 participants

Study Classification

INTERVENTIONAL

Study Start Date

2017-07-01

Study Completion Date

2019-06-30

Brief Summary

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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

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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.

Conditions

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Vessels; Anomaly

Study Design

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Allocation Method

NA

Intervention Model

SINGLE_GROUP

Data driven analysis
Primary Study Purpose

DIAGNOSTIC

Blinding Strategy

NONE

Study Groups

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Experimental arm

Measurement RVA / IOP / with ECG gating

Group Type EXPERIMENTAL

Retinal Vessel Analyzer recordings with electrocardiographic (ECG) gating

Intervention Type DEVICE

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

Interventions

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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.

Intervention Type DEVICE

Eligibility Criteria

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Inclusion Criteria

\-

Exclusion Criteria

Known ophthalmological disease, in particular vascular disease.
Minimum Eligible Age

20 Years

Maximum Eligible Age

35 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

Yes

Sponsors

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University Hospital, Basel, Switzerland

OTHER

Sponsor Role lead

Responsible Party

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Responsibility Role SPONSOR

Locations

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University Eye Hospital

Basel, Baseƶ, Switzerland

Site Status

Countries

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Switzerland

Other Identifiers

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2017-01036

Identifier Type: -

Identifier Source: org_study_id

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