Trypan Blue Versus Brillant Blue for Epiretinal Membranes
Primary Purpose
Idiopathic Epiretinal Membranes
Status
Completed
Phase
Not Applicable
Locations
Austria
Study Type
Interventional
Intervention
Trypan Blue
Brillant Blue
Sponsored by
About this trial
This is an interventional treatment trial for Idiopathic Epiretinal Membranes focused on measuring epiretinal membranes, vitreoretinal dyes, membranepeeling
Eligibility Criteria
Inclusion Criteria:
- Idiopathic eperetinal membranes
- Phakic or pseudophakic eyes
- Age over 60 years
Exclusion Criteria:
- Secondary epiretinal membranes
- Severe ocular pathologies
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
Trypan Blue
Brillant Blue
Outcomes
Primary Outcome Measures
Visual acuity
Secondary Outcome Measures
Microperimetry optical coherence tomographie questionnaire (metamorphopsien)
Full Information
NCT ID
NCT00757380
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
NCT00757380
Brief Title
Trypan Blue Versus Brillant Blue for Epiretinal Membranes
Official Title
Membranepeeling With Trypan Blue Versus Membranpeeling With Brillant Blue for Patients With Idiopathic Epiretinal Membranes
Study Type
Interventional
2. Study Status
Record Verification Date
January 2016
Overall Recruitment Status
Completed
Study Start Date
July 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
Membraneppeling alone versus Membranepeeling with Membrane Limitans Interna Pelling using two different Dyes for Epiretinal Membrane Surgery.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Idiopathic Epiretinal Membranes
Keywords
epiretinal membranes, vitreoretinal dyes, membranepeeling
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
Trypan Blue
Arm Title
Group 2
Arm Type
Active Comparator
Arm Description
Brillant Blue
Intervention Type
Procedure
Intervention Name(s)
Trypan Blue
Intervention Description
Membranepeeling with TB
Intervention Type
Procedure
Intervention Name(s)
Brillant Blue
Intervention Description
Membranepeeling and membrana limitans interna peeling with BB
Primary Outcome Measure Information:
Title
Visual acuity
Time Frame
3 months
Secondary Outcome Measure Information:
Title
Microperimetry optical coherence tomographie questionnaire (metamorphopsien)
Time Frame
3 months
10. Eligibility
Sex
All
Minimum Age & Unit of Time
60 Years
Accepts Healthy Volunteers
Accepts Healthy Volunteers
Eligibility Criteria
Inclusion Criteria:
Idiopathic eperetinal membranes
Phakic or pseudophakic eyes
Age over 60 years
Exclusion Criteria:
Secondary epiretinal membranes
Severe ocular pathologies
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Katharina Kreppler, Univ. Doz. Dr.
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, Dr.
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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Trypan Blue Versus Brillant Blue for Epiretinal Membranes
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