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

Sponsor
Vienna Institute for Research in Ocular Surgery (Other)
Overall Status
Completed
CT.gov ID
NCT03646682
Collaborator
(none)
40
Enrollment
1
Location
2
Arms
15.6
Actual Duration (Months)
2.6
Patients Per Site Per Month

Study Details

Study Description

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
  • Procedure: vitrectomy with membrane peeling
 N/A

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

Study Type:
Interventional
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 :
Aug 13, 2018
Actual Primary Completion Date :
Dec 1, 2019
Actual Study Completion Date :
Dec 1, 2019

Arms and Interventions

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

Primary Outcome Measures

  1. concentration of caffeine in vitreous probes and epiretinal membranes [one hour]

    concentration of caffeine in the probes will be measuread by gas-chromatography/mass spectrometry

Eligibility Criteria

Criteria

Ages Eligible for Study:
18 Years and Older
Sexes Eligible for Study:
All
Accepts Healthy Volunteers:
No
Inclusion Criteria:
  • epiretinale membrane
Exclusion Criteria:
  • none

Contacts and Locations

Locations

Site City State Country Postal Code
1 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

  • Principal Investigator: Oliver Findl, Professor, Vienna Institute for Research in Ocular Surgery

Study Documents (Full-Text)

None provided.

More Information

Publications

None provided.
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:
Aug 24, 2018
Last Update Posted:
Mar 10, 2020
Last Verified:
Mar 1, 2020
Studies a U.S. FDA-regulated Drug Product:
No
Studies a U.S. FDA-regulated Device Product:
No
Additional relevant MeSH terms:
Epiretinal Membrane

Study Results

No Results Posted as of Mar 10, 2020