Back to resultsBrillant Blue Versus Indocyanine Green for Macular Hole Surgery
Primary Purpose
Idiopathic Macular Holes
Status
Completed
Phase
Not Applicable
Locations
Austria
Study Type
Interventional
Intervention
Brillant Blue
Indocyanine Green
Sponsored by
About this trial
This is an interventional treatment trial for Idiopathic Macular Holes focused on measuring Macular hole surgery, membranepeeling, closure rate, vitreoretinal dyes
Eligibility 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
Sites / Locations
- The Ludwig Boltzmann Institute of Retinology and Biomicroscopic Laser surgery
Arms of the Study
Arm 1
Arm 2
Arm Type
Active Comparator
Active Comparator
Arm Label
Group 1
Group 2
Arm Description
Brillant Blue
Indocyanine Green
Outcomes
Primary Outcome Measures
Macular Hole Closure Rate
Secondary Outcome Measures
Visual Acuity Microperimetry Optical Coherence Tomography
Full Information
NCT ID
NCT00757471
First Posted
September 21, 2008
Last Updated
January 24, 2016
Sponsor
The Ludwig Boltzmann Institute of Retinology and Biomicroscopic Laser Surgery
1. Study Identification
Unique Protocol Identification Number
NCT00757471
Brief Title
Brillant Blue Versus Indocyanine Green for Macular Hole Surgery
Official Title
Membranepeeling With Brillant Blue Versus Membranepeeling With Indocyanine Green for Patients With Idiopathic Macular Holes.
Study Type
Interventional
2. Study Status
Record Verification Date
January 2016
Overall Recruitment Status
Completed
Study Start Date
August 2008 (undefined)
Primary Completion Date
August 2015 (Actual)
Study Completion Date
August 2015 (Actual)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
The Ludwig Boltzmann Institute of Retinology and Biomicroscopic Laser Surgery
4. Oversight
Data Monitoring Committee
No
5. Study Description
Brief Summary
Macular Hole Surgery with two different Dyes
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Idiopathic Macular Holes
Keywords
Macular hole surgery, membranepeeling, closure rate, vitreoretinal dyes
7. Study Design
Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
Outcomes Assessor
Allocation
Randomized
Enrollment
60 (Actual)
8. Arms, Groups, and Interventions
Arm Title
Group 1
Arm Type
Active Comparator
Arm Description
Brillant Blue
Arm Title
Group 2
Arm Type
Active Comparator
Arm Description
Indocyanine Green
Intervention Type
Procedure
Intervention Name(s)
Brillant Blue
Intervention Description
Membrane Peeling with Brillant Blue
Intervention Type
Procedure
Intervention Name(s)
Indocyanine Green
Intervention Description
Membrane Peeling with indocyanine Green
Primary Outcome Measure Information:
Title
Macular Hole Closure Rate
Time Frame
12 Months
Secondary Outcome Measure Information:
Title
Visual Acuity Microperimetry Optical Coherence Tomography
Time Frame
12 Months
10. Eligibility
Sex
All
Minimum Age & Unit of Time
60 Years
Accepts Healthy Volunteers
Accepts Healthy Volunteers
Eligibility 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
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Katharina Kreppler, MD
Organizational Affiliation
The Ludwig Boltzmann Institute of Retinology and Biomicroscopic Laser Surgery
Official's Role
Study Chair
First Name & Middle Initial & Last Name & Degree
Christiane I Falkner-Radler, MD
Organizational Affiliation
The Ludwig Boltzmann Institute of Retinology and Biomicroscopic Laser Surgery
Official's Role
Principal Investigator
Facility Information:
Facility Name
The Ludwig Boltzmann Institute of Retinology and Biomicroscopic Laser surgery
City
Vienna
ZIP/Postal Code
1030
Country
Austria
12. IPD Sharing Statement
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Brillant Blue Versus Indocyanine Green for Macular Hole Surgery
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