NCT03646682

Brief Summary

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

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
40

participants targeted

Target at P25-P50 for not_applicable

Timeline
Completed

Started Aug 2018

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

August 13, 2018

Completed
10 days until next milestone

First Submitted

Initial submission to the registry

August 23, 2018

Completed
1 day until next milestone

First Posted

Study publicly available on registry

August 24, 2018

Completed
1.3 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

December 1, 2019

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

December 1, 2019

Completed
Last Updated

March 10, 2020

Status Verified

March 1, 2020

Enrollment Period

1.3 years

First QC Date

August 23, 2018

Last Update Submit

March 9, 2020

Conditions

Epiretinal Membrane

Outcome Measures

Primary Outcomes (1)

  • concentration of caffeine in vitreous probes and epiretinal membranes

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

    one hour

Study Arms (2)

caffeine group

EXPERIMENTAL

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

Procedure: vitrectomy with membrane peeling

control group

ACTIVE COMPARATOR

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

Procedure: vitrectomy with membrane peeling

Interventions

vitrectomy with membrane peelingPROCEDURE

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

caffeine groupcontrol group

Eligibility Criteria

Age18 Years+
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • epiretinale membrane

You may not qualify if:

  • none

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

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

Vienna, 1140, Austria

Location

MeSH Terms

Conditions

Epiretinal Membrane

Interventions

Vitrectomy

Condition Hierarchy (Ancestors)

Retinal DiseasesEye Diseases

Intervention Hierarchy (Ancestors)

Ophthalmologic Surgical ProceduresSurgical Procedures, Operative

Study Officials

  • Oliver Findl, Professor

    Vienna Institute for Research in Ocular Surgery

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
interventional
Phase
not applicable
Allocation
NON RANDOMIZED
Masking
NONE
Purpose
DIAGNOSTIC
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Head of Department of Ophthalmology, Professor, MBA

Study Record Dates

First Submitted

August 23, 2018

First Posted

August 24, 2018

Study Start

August 13, 2018

Primary Completion

December 1, 2019

Study Completion

December 1, 2019

Last Updated

March 10, 2020

Record last verified: 2020-03

Locations

AU(1)