Back to resultsPharmakokinetik of Caffeine in Epiretinal Membranes After Oral Intake: a Pilot Study
Primary Purpose
Epiretinal Membrane
Status
Completed
Phase
Not Applicable
Locations
Austria
Study Type
Interventional
Intervention
vitrectomy with membrane peeling
Sponsored by
About this trial
This is an interventional diagnostic trial for Epiretinal Membrane
Eligibility Criteria
Inclusion Criteria:
- epiretinale membrane
Exclusion Criteria:
- none
Sites / Locations
- Vienna Institute for Research in Ocular Surgery (VIROS), Hanusch Hospital Vienna
Arms of the Study
Arm 1
Arm 2
Arm Type
Experimental
Active Comparator
Arm Label
caffeine group
control group
Arm Description
180mg of caffeine will be given orally one jour before vitrectomy with membrane peeling
no caffeine will be given before vitrectomy with membrane peeling, patients are drinking no coffee in general
Outcomes
Primary Outcome Measures
concentration of caffeine in vitreous probes and epiretinal membranes
concentration of caffeine in the probes will be measuread by gas-chromatography/mass spectrometry
Secondary Outcome Measures
Full Information
NCT ID
NCT03646682
First Posted
August 23, 2018
Last Updated
March 9, 2020
Sponsor
Vienna Institute for Research in Ocular Surgery
1. Study Identification
Unique Protocol Identification Number
NCT03646682
Brief Title
Pharmakokinetik of Caffeine in Epiretinal Membranes After Oral Intake: a Pilot Study
Official Title
Pharmakokinetik of Caffeine in Epiretinal Membranes After Oral Intake: a Pilot Study
Study Type
Interventional
2. Study Status
Record Verification Date
March 2020
Overall Recruitment Status
Completed
Study Start Date
August 13, 2018 (Actual)
Primary Completion Date
December 1, 2019 (Actual)
Study Completion Date
December 1, 2019 (Actual)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
Vienna Institute for Research in Ocular Surgery
4. Oversight
Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
5. Study Description
Brief Summary
Caffeine concentrations in the vitreous Body and exzised epiretinal membranes are measured by gas-chromatography/mass spectrometry.
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
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Epiretinal Membrane
7. Study Design
Primary Purpose
Diagnostic
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
None (Open Label)
Allocation
Non-Randomized
Enrollment
40 (Actual)
8. Arms, Groups, and Interventions
Arm Title
caffeine group
Arm Type
Experimental
Arm Description
180mg of caffeine will be given orally one jour before vitrectomy with membrane peeling
Arm Title
control group
Arm Type
Active Comparator
Arm Description
no caffeine will be given before vitrectomy with membrane peeling, patients are drinking no coffee in general
Intervention Type
Procedure
Intervention Name(s)
vitrectomy with membrane peeling
Intervention Description
during vitrectomy with membrane peeling a prob of the vitreous body and the excised epiretinal membrane will be harvested for gas-chromatography/mass spectrometry
Primary Outcome Measure Information:
Title
concentration of caffeine in vitreous probes and epiretinal membranes
Description
concentration of caffeine in the probes will be measuread by gas-chromatography/mass spectrometry
Time Frame
one hour
10. Eligibility
Sex
All
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria:
epiretinale membrane
Exclusion Criteria:
none
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Oliver Findl, Professor
Organizational Affiliation
Vienna Institute for Research in Ocular Surgery
Official's Role
Principal Investigator
Facility Information:
Facility Name
Vienna Institute for Research in Ocular Surgery (VIROS), Hanusch Hospital Vienna
City
Vienna
ZIP/Postal Code
1140
Country
Austria
12. IPD Sharing Statement
Learn more about this trial
Pharmakokinetik of Caffeine in Epiretinal Membranes After Oral Intake: a Pilot Study
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