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Trypan Blue Versus Brillant Blue for Epiretinal Membranes
This study is currently recruiting participants.
Verified by The Ludwig Boltzmann Institute of Retinology and Biomicroscopic Laser Surgery, September 2008
First Received: September 21, 2008   Last Updated: September 22, 2008   History of Changes
Sponsored by: The Ludwig Boltzmann Institute of Retinology and Biomicroscopic Laser Surgery
Information provided by: The Ludwig Boltzmann Institute of Retinology and Biomicroscopic Laser Surgery
ClinicalTrials.gov Identifier: NCT00757380
  Purpose

Membraneppeling alone versus Membranepeeling with Membrane Limitans Interna Pelling using two different Dyes for Epiretinal Membrane Surgery.


Condition Intervention
Idiopathic Epiretinal Membranes
Procedure: Trypan Blue
Procedure: Brillant Blue

MedlinePlus related topics: Surgery
U.S. FDA Resources
Study Type: Interventional
Study Design: Treatment, Randomized, Single Blind (Outcomes Assessor), Active Control, Parallel Assignment
Official Title: Membranepeeling With Trypan Blue Versus Membranpeeling With Brillant Blue for Patients With Idiopathic Epiretinal Membranes

Further study details as provided by The Ludwig Boltzmann Institute of Retinology and Biomicroscopic Laser Surgery:

Primary Outcome Measures:
  • Visual acuity [ Time Frame: 3 months ] [ Designated as safety issue: Yes ]

Secondary Outcome Measures:
  • Microperimetry optical coherence tomographie questionnaire (metamorphopsien) [ Time Frame: 3 months ] [ Designated as safety issue: Yes ]

Estimated Enrollment: 60
Study Start Date: July 2008
Estimated Study Completion Date: December 2010
Estimated Primary Completion Date: December 2010 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Group 1: Active Comparator
Trypan Blue
Procedure: Trypan Blue
Membranepeeling with TB
Group 2: Active Comparator
Brillant Blue
Procedure: Brillant Blue
Membranepeeling and membrana limitans interna peeling with BB

  Eligibility

Ages Eligible for Study:   60 Years and older
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   Yes
Criteria

Inclusion Criteria:

  • Idiopathic eperetinal membranes
  • Phakic or pseudophakic eyes
  • Age over 60 years

Exclusion Criteria:

  • Secondary epiretinal membranes
  • Severe ocular pathologies
  Contacts and Locations
Please refer to this study by its ClinicalTrials.gov identifier: NCT00757380

Contacts
Contact: Susanne Binder, Univ. Prof. Dr. +431711654607 susanne.binder@wienkav.at
Contact: Christiane I Falkner-Radler, Dr. +431711654607 christiane.falkner-radler@wienkav.at

Locations
Austria
The Ludwig Boltzmann Institute of Retinology and Biomicroscopic Laser Surgery Recruiting
Vienna, Austria, 1030
Contact: Christiane I Falkner-Radler, Dr.     +431711654607     christiane.falkner-radler@wienkav.at    
Principal Investigator: Christiane I Falkner-Radler, Dr.            
Sponsors and Collaborators
The Ludwig Boltzmann Institute of Retinology and Biomicroscopic Laser Surgery
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
  More Information

No publications provided

Responsible Party: The Ludwig Boltzmann Institute of Retinology and Biomicroscopic Laser Surgery ( The Ludwig Boltzmann Institute of Retinology and Biomicroscopic Laser Surgery )
Study ID Numbers: FR-4-CI-2008
Study First Received: September 21, 2008
Last Updated: September 22, 2008
ClinicalTrials.gov Identifier: NCT00757380     History of Changes
Health Authority: Austria: Ethikkommission

Keywords provided by The Ludwig Boltzmann Institute of Retinology and Biomicroscopic Laser Surgery:
epiretinal membranes
vitreoretinal dyes
membranepeeling

Study placed in the following topic categories:
Eye Diseases
Epiretinal Membrane
Diminazene aceturate
Retinal Diseases

Additional relevant MeSH terms:
Anti-Infective Agents
Trypanocidal Agents
Antiparasitic Agents
Antiprotozoal Agents
Therapeutic Uses
Eye Diseases
Epiretinal Membrane
Diminazene aceturate
Pharmacologic Actions
Retinal Diseases

ClinicalTrials.gov processed this record on May 07, 2009