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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
The Ludwig Boltzmann Institute of Retinology and Biomicroscopic Laser Surgery
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Idiopathic Epiretinal Membranes focused on measuring epiretinal membranes, vitreoretinal dyes, membranepeeling

Eligibility Criteria

60 Years - undefined (Adult, Older Adult)All SexesAccepts Healthy Volunteers

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

First Posted
September 21, 2008
Last Updated
January 24, 2016
Sponsor
The Ludwig Boltzmann Institute of Retinology and Biomicroscopic Laser Surgery
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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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