Brillant Blue Versus Indocyanine Green for Macular Hole Surgery
January 24, 2016 updated by: Dr. Christiane I. Falkner-Radler, The Ludwig Boltzmann Institute of Retinology and Biomicroscopic Laser Surgery
Membranepeeling With Brillant Blue Versus Membranepeeling With Indocyanine Green for Patients With Idiopathic Macular Holes.
Macular Hole Surgery with two different Dyes
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
No
Genders Eligible for Study
All
Description
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
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 Assignment
- Masking: Single
Arms and Interventions
Participant Group / Arm |
Intervention / Treatment |
|---|---|
|
Active Comparator: Group 1
Brillant Blue
|
Membrane Peeling with Brillant Blue
|
|
Active Comparator: Group 2
Indocyanine Green
|
Membrane Peeling with indocyanine Green
|
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Time Frame |
|---|---|
|
Macular Hole Closure Rate
Time Frame: 12 Months
|
12 Months
|
Secondary Outcome Measures
Outcome Measure |
Time Frame |
|---|---|
|
Visual Acuity Microperimetry Optical Coherence Tomography
Time Frame: 12 Months
|
12 Months
|
Collaborators and Investigators
This is where you will find people and organizations involved with this study.
Investigators
- Study Chair: Katharina Kreppler, MD, The Ludwig Boltzmann Institute of Retinology and Biomicroscopic Laser Surgery
- Principal Investigator: Christiane I Falkner-Radler, MD, 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
August 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-5-CI-2008
Drug and device information, study documents
Studies a U.S. FDA-regulated drug product
No
Studies a U.S. FDA-regulated device product
No
product manufactured in and exported from the U.S.
No
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.