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Trypan Blue Versus Brillant Blue for Epiretinal Membranes

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
ClinicalTrials.gov Identifier: NCT00757380
Recruitment Status : Completed
First Posted : September 23, 2008
Last Update Posted : January 26, 2016
Sponsor:
Information provided by (Responsible Party):

Study Description
Brief Summary:
Membraneppeling alone versus Membranepeeling with Membrane Limitans Interna Pelling using two different Dyes for Epiretinal Membrane Surgery.

Condition or disease Intervention/treatment
Idiopathic Epiretinal Membranes Procedure: Trypan Blue Procedure: Brillant Blue

Study Design

Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 60 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Single (Outcomes Assessor)
Primary Purpose: Treatment
Official Title: Membranepeeling With Trypan Blue Versus Membranpeeling With Brillant Blue for Patients With Idiopathic Epiretinal Membranes
Study Start Date : July 2008
Primary Completion Date : August 2015
Study Completion Date : August 2015

Resource links provided by the National Library of Medicine

U.S. FDA Resources

Arms and Interventions

Arm Intervention/treatment
Active Comparator: Group 1
Trypan Blue
Procedure: Trypan Blue
Membranepeeling with TB
Active Comparator: Group 2
Brillant Blue
Procedure: Brillant Blue
Membranepeeling and membrana limitans interna peeling with BB


Outcome Measures

Primary Outcome Measures :
  1. Visual acuity [ Time Frame: 3 months ]

Secondary Outcome Measures :
  1. Microperimetry optical coherence tomographie questionnaire (metamorphopsien) [ Time Frame: 3 months ]

Eligibility Criteria

Information from the National Library of Medicine

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Ages Eligible for Study:   60 Years and older   (Adult, Senior)
Sexes Eligible for Study:   All
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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT00757380


Locations
Austria
The Ludwig Boltzmann Institute of Retinology and Biomicroscopic Laser Surgery
Vienna, Austria, 1030
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

Responsible Party: Dr. Christiane I. Falkner-Radler, MD, The Ludwig Boltzmann Institute of Retinology and Biomicroscopic Laser Surgery
ClinicalTrials.gov Identifier: NCT00757380     History of Changes
Other Study ID Numbers: FR-4-CI-2008
First Posted: September 23, 2008    Key Record Dates
Last Update Posted: January 26, 2016
Last Verified: January 2016

Keywords provided by Dr. Christiane I. Falkner-Radler, The Ludwig Boltzmann Institute of Retinology and Biomicroscopic Laser Surgery:
epiretinal membranes
vitreoretinal dyes
membranepeeling

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