Pharmakokinetik of Caffeine in Epiretinal Membranes After Oral Intake: a Pilot Study

NCT ID: NCT03646682

Last Updated: 2020-03-10

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

40 participants

Study Classification

INTERVENTIONAL

Study Start Date

2018-08-13

Study Completion Date

2019-12-01

Brief Summary

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Caffeine concentrations in the vitreous Body and exzised epiretinal membranes are measured by gas-chromatography/mass spectrometry.

Detailed Description

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Caffeine concentrations in the vitreous Body and exzised epiretinal membranes are measured by gas-chromatography/mass spectrometry. One hour before surgery patients in the caffeine Group will receive 180mg of caffeine. in all patients vitrectomy with Membrane Peeling will be performed, due to epiretinal membranes

Conditions

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Epiretinal Membrane

Study Design

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Allocation Method

NON_RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

DIAGNOSTIC

Blinding Strategy

NONE

Study Groups

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caffeine group

180mg of caffeine will be given orally one jour before vitrectomy with membrane peeling

Group Type EXPERIMENTAL

vitrectomy with membrane peeling

Intervention Type PROCEDURE

during vitrectomy with membrane peeling a prob of the vitreous body and the excised epiretinal membrane will be harvested for gas-chromatography/mass spectrometry

control group

no caffeine will be given before vitrectomy with membrane peeling, patients are drinking no coffee in general

Group Type ACTIVE_COMPARATOR

vitrectomy with membrane peeling

Intervention Type PROCEDURE

during vitrectomy with membrane peeling a prob of the vitreous body and the excised epiretinal membrane will be harvested for gas-chromatography/mass spectrometry

Interventions

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vitrectomy with membrane peeling

during vitrectomy with membrane peeling a prob of the vitreous body and the excised epiretinal membrane will be harvested for gas-chromatography/mass spectrometry

Intervention Type PROCEDURE

Eligibility Criteria

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Inclusion Criteria

* epiretinale membrane

Exclusion Criteria

* none
Minimum Eligible Age

18 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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Vienna Institute for Research in Ocular Surgery

OTHER

Sponsor Role lead

Responsible Party

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Prim. Prof. Dr. Oliver Findl, MBA

Head of Department of Ophthalmology, Professor, MBA

Responsibility Role PRINCIPAL_INVESTIGATOR

Principal Investigators

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Oliver Findl, Professor

Role: PRINCIPAL_INVESTIGATOR

Vienna Institute for Research in Ocular Surgery

Locations

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Vienna Institute for Research in Ocular Surgery (VIROS), Hanusch Hospital Vienna

Vienna, , Austria

Site Status

Countries

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Austria

Other Identifiers

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CaffERM

Identifier Type: -

Identifier Source: org_study_id

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