Brillant Blue Versus Indocyanine Green for Macular Hole Surgery

The recruitment status of this study is unknown because the information has not been verified recently.
Verified August 2011 by The Ludwig Boltzmann Institute of Retinology and Biomicroscopic Laser Surgery.
Recruitment status was  Recruiting
Sponsor:
Information provided by:
The Ludwig Boltzmann Institute of Retinology and Biomicroscopic Laser Surgery
ClinicalTrials.gov Identifier:
NCT00757471
First received: September 21, 2008
Last updated: August 8, 2011
Last verified: August 2011
  Purpose

Macular Hole Surgery with two different Dyes


Condition Intervention
Idiopathic Macular Holes
Procedure: Brillant Blue
Procedure: Indocyanine Green

Study Type: Interventional
Study Design: Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Single Blind (Outcomes Assessor)
Primary Purpose: Treatment
Official Title: Membranepeeling With Brillant Blue Versus Membranepeeling With Indocyanine Green for Patients With Idiopathic Macular Holes.

Resource links provided by NLM:


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

Primary Outcome Measures:
  • Macular Hole Closure Rate [ Time Frame: 12 Months ] [ Designated as safety issue: Yes ]

Secondary Outcome Measures:
  • Visual Acuity Microperimetry Optical Coherence Tomography [ Time Frame: 12 Months ] [ Designated as safety issue: Yes ]

Estimated Enrollment: 60
Study Start Date: August 2008
Estimated Study Completion Date: August 2013
Estimated Primary Completion Date: August 2013 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Active Comparator: Group 1
Brillant Blue
Procedure: Brillant Blue
Membrane Peeling with Brillant Blue
Active Comparator: Group 2
Indocyanine Green
Procedure: Indocyanine Green
Membrane Peeling with indocyanine Green

  Eligibility

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

Inclusion Criteria:

  • Idiopathic stage 3 and 4 macular holes
  • Stage 2 macular holes, followed up for at least 6 months
  • Pseudophakic and phakic eyes
  • Age over 60 years

Exclusion Criteria:

  • Traumatic macular holes
  • Secondary macular holes
  • Severe ocular diseases
  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: NCT00757471

Contacts
Contact: Susanne Binder, Univ. Prof. Dr. +431711654607 susanne.binder@wienkav.at
Contact: Christiane I Falkner-Radler, Dr. +43711654607 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
ClinicalTrials.gov Identifier: NCT00757471     History of Changes
Other Study ID Numbers: FR-5-CI-2008
Study First Received: September 21, 2008
Last Updated: August 8, 2011
Health Authority: Austria: Ethikkommission

Keywords provided by The Ludwig Boltzmann Institute of Retinology and Biomicroscopic Laser Surgery:
Macular hole surgery
membranepeeling
closure rate
vitreoretinal dyes

Additional relevant MeSH terms:
Retinal Perforations
Eye Diseases
Retinal Diseases

ClinicalTrials.gov processed this record on October 23, 2014