Try the modernized ClinicalTrials.gov beta website. Learn more about the modernization effort.
Working…
ClinicalTrials.gov
ClinicalTrials.gov Menu

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

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT03646682
Recruitment Status : Completed
First Posted : August 24, 2018
Last Update Posted : March 10, 2020
Sponsor:
Information provided by (Responsible Party):
Prim. Prof. Dr. Oliver Findl, MBA, Vienna Institute for Research in Ocular Surgery

Study Description
Go to 
Top of Page Study Description Study Design Arms and Interventions Outcome Measures Eligibility Criteria Contacts and Locations More Information
Brief Summary:
Caffeine concentrations in the vitreous Body and exzised epiretinal membranes are measured by gas-chromatography/mass spectrometry.

Condition or disease Intervention/treatment Phase
Epiretinal Membrane Procedure: vitrectomy with membrane peeling Not Applicable

Detailed Description:
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
Study Design
Go to 
Top of Page Study Description Study Design Arms and Interventions Outcome Measures Eligibility Criteria Contacts and Locations More Information

Layout table for study information
Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 40 participants
Allocation: Non-Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)
Primary Purpose: Diagnostic
Official Title: Pharmakokinetik of Caffeine in Epiretinal Membranes After Oral Intake: a Pilot Study
Actual Study Start Date : August 13, 2018
Actual Primary Completion Date : December 1, 2019
Actual Study Completion Date : December 1, 2019

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Caffeine

Arms and Interventions
Go to 
Top of Page Study Description Study Design Arms and Interventions Outcome Measures Eligibility Criteria Contacts and Locations More Information

Arm Intervention/treatment
Experimental: caffeine group
180mg of caffeine will be given orally one jour before vitrectomy with membrane peeling
 Procedure: 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
Active Comparator: control group
no caffeine will be given before vitrectomy with membrane peeling, patients are drinking no coffee in general
 Procedure: 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


Outcome Measures
Go to 
Top of Page Study Description Study Design Arms and Interventions Outcome Measures Eligibility Criteria Contacts and Locations More Information

Primary Outcome Measures :
  1. concentration of caffeine in vitreous probes and epiretinal membranes [ Time Frame: one hour ]
    concentration of caffeine in the probes will be measuread by gas-chromatography/mass spectrometry


Eligibility Criteria
Go to 
Top of Page Study Description Study Design Arms and Interventions Outcome Measures Eligibility Criteria Contacts and Locations More Information

Information from the National Library of Medicine

Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the contacts provided below. For general information, Learn About Clinical Studies.


Layout table for eligibility information
Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

  • epiretinale membrane

Exclusion Criteria:

  • none
Contacts and Locations
Go to 
Top of Page Study Description Study Design Arms and Interventions Outcome Measures Eligibility Criteria Contacts and Locations More Information

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT03646682


Locations
Layout table for location information
Austria
Vienna Institute for Research in Ocular Surgery (VIROS), Hanusch Hospital Vienna
Vienna, Austria, 1140
Sponsors and Collaborators
Vienna Institute for Research in Ocular Surgery
Investigators
Layout table for investigator information
Principal Investigator: Oliver Findl, Professor Vienna Institute for Research in Ocular Surgery
More Information
Go to 
Top of Page Study Description Study Design Arms and Interventions Outcome Measures Eligibility Criteria Contacts and Locations More Information
Layout table for additonal information
Responsible Party: Prim. Prof. Dr. Oliver Findl, MBA, Head of Department of Ophthalmology, Professor, MBA, Vienna Institute for Research in Ocular Surgery
ClinicalTrials.gov Identifier: NCT03646682    
Other Study ID Numbers: CaffERM
First Posted: August 24, 2018    Key Record Dates
Last Update Posted: March 10, 2020
Last Verified: March 2020

Layout table for additional information
Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
Additional relevant MeSH terms:
Layout table for MeSH terms
Epiretinal Membrane
Retinal Diseases
Eye Diseases