- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT00757380
Trypan Blue Versus Brillant Blue for Epiretinal Membranes
January 24, 2016 updated by: Dr. Christiane I. Falkner-Radler, The Ludwig Boltzmann Institute of Retinology and Biomicroscopic Laser Surgery
Membranepeeling With Trypan Blue Versus Membranpeeling With Brillant Blue for Patients With Idiopathic Epiretinal Membranes
Membraneppeling alone versus Membranepeeling with Membrane Limitans Interna Pelling using two different Dyes for Epiretinal Membrane Surgery.
Study Overview
Status
Completed
Conditions
Intervention / Treatment
Study Type
Interventional
Enrollment (Actual)
60
Phase
- Not Applicable
Contacts and Locations
This section provides the contact details for those conducting the study, and information on where this study is being conducted.
Study Locations
-
-
-
Vienna, Austria, 1030
- The Ludwig Boltzmann Institute of Retinology and Biomicroscopic Laser Surgery
-
-
Participation Criteria
Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.
Eligibility Criteria
Ages Eligible for Study
60 years and older (ADULT, OLDER_ADULT)
Accepts Healthy Volunteers
Yes
Genders Eligible for Study
All
Description
Inclusion Criteria:
- Idiopathic eperetinal membranes
- Phakic or pseudophakic eyes
- Age over 60 years
Exclusion Criteria:
- Secondary epiretinal membranes
- Severe ocular pathologies
Study Plan
This section provides details of the study plan, including how the study is designed and what the study is measuring.
How is the study designed?
Design Details
- Primary Purpose: TREATMENT
- Allocation: RANDOMIZED
- Interventional Model: PARALLEL
- Masking: SINGLE
Arms and Interventions
Participant Group / Arm |
Intervention / Treatment |
---|---|
ACTIVE_COMPARATOR: Group 1
Trypan Blue
|
Membranepeeling with TB
|
ACTIVE_COMPARATOR: Group 2
Brillant Blue
|
Membranepeeling and membrana limitans interna peeling with BB
|
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Time Frame |
---|---|
Visual acuity
Time Frame: 3 months
|
3 months
|
Secondary Outcome Measures
Outcome Measure |
Time Frame |
---|---|
Microperimetry optical coherence tomographie questionnaire (metamorphopsien)
Time Frame: 3 months
|
3 months
|
Collaborators and Investigators
This is where you will find people and organizations involved with this study.
Investigators
- Study Chair: Katharina Kreppler, Univ. Doz. Dr., The Ludwig Boltzmann Institute of Retinology and Biomicroscopic Laser Surgery
- Principal Investigator: Christiane I Falkner-Radler, Dr., The Ludwig Boltzmann Institute of Retinology and Biomicroscopic Laser Surgery
Study record dates
These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.
Study Major Dates
Study Start
July 1, 2008
Primary Completion (ACTUAL)
August 1, 2015
Study Completion (ACTUAL)
August 1, 2015
Study Registration Dates
First Submitted
September 21, 2008
First Submitted That Met QC Criteria
September 22, 2008
First Posted (ESTIMATE)
September 23, 2008
Study Record Updates
Last Update Posted (ESTIMATE)
January 26, 2016
Last Update Submitted That Met QC Criteria
January 24, 2016
Last Verified
January 1, 2016
More Information
Terms related to this study
Additional Relevant MeSH Terms
Other Study ID Numbers
- FR-4-CI-2008
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
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