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Trypan Blue Versus Brillant Blue for Epiretinal Membranes

This study has been completed.
Sponsor:
Information provided by (Responsible Party):
Dr. Christiane I. Falkner-Radler, The Ludwig Boltzmann Institute of Retinology and Biomicroscopic Laser Surgery
ClinicalTrials.gov Identifier:
NCT00757380
First received: September 21, 2008
Last updated: January 24, 2016
Last verified: January 2016
  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

Study Type: Interventional
Study Design: Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Single Blind (Outcomes Assessor)
Primary Purpose: Treatment
Official Title: Membranepeeling With Trypan Blue Versus Membranpeeling With Brillant Blue for Patients With Idiopathic Epiretinal Membranes

Resource links provided by NLM:


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 ]

Enrollment: 60
Study Start Date: July 2008
Study Completion Date: August 2015
Primary Completion Date: August 2015 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
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

  Eligibility

Ages Eligible for Study:   60 Years and older   (Adult, Senior)
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
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: 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 
Study First Received: September 21, 2008
Last Updated: January 24, 2016
Health Authority: Austria: Ethikkommission

Keywords provided by 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

ClinicalTrials.gov processed this record on September 26, 2016