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

NCT03646682 — Not applicable, Completed, 40 participants, Vienna Institute for Research in Ocular Surgery

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RegistryNCT03646682
StatusCompleted
PhaseNot applicable
Study typeInterventional; non randomized, parallel, masking: none, diagnostic
Enrollment40 (Actual)
SponsorVienna Institute for Research in Ocular Surgery (Other)
ConditionsEpiretinal Membrane
Interventionsvitrectomy with membrane peeling (Procedure)
Datesstart 2018-08-13, primary completion 2019-12-01, completion 2019-12-01, first posted 2018-08-24, last updated 2020-03-10
Locations1 site in Austria

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-Summary

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

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+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

+Arms and interventions

ArmTypeInterventionsDescription
caffeine groupExperimentalProcedure: vitrectomy with membrane peeling180mg of caffeine will be given orally one jour before vitrectomy with membrane peeling
control groupActive comparatorProcedure: vitrectomy with membrane peelingno caffeine will be given before vitrectomy with membrane peeling, patients are drinking no coffee in general
  • vitrectomy with membrane peeling (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

+Outcome measures

Primary outcomes

  • 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

Sex: All, ages: 18 Years to any

Inclusion Criteria:

* epiretinale membrane

Exclusion Criteria:

* none

+Locations (1)

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

+Investigators

My Notes