Trypan Blue Versus Brillant Blue for Epiretinal Membranes | NCT00757380

Studies
Trypan Blue Versus Brillant Blue for Epiretinal Membranes

NCT00757380

Sponsor

The Ludwig Boltzmann Institute of Retinology and Biomicroscopic Laser Surgery

Status

Completed

Last Update Posted

Jan 26, 2016Estimated

Enrollment

60Actual

Phase

Not Applicable

Conditions

Idiopathic Epiretinal Membranes

Interventions

Trypan Blue
Brillant Blue

Countries

Austria

Protocol Section

Identification Module Status Module Sponsor/Collaborators Module Oversight Module Description Module Conditions Module Design Module Arms/Interventions Module Outcomes Module Eligibility Module Contacts/Locations Module References Module IPD Sharing Statement Module

Results Section

Participant Flow Module Baseline Characteristics Module Outcome Measures Module Adverse Events Module More Info Module

Annotation Section

Annotation Module

Document Section

Large Document Module

Derived Section

Miscellaneous Info Module Condition Browse Module Intervention Browse Module

Protocol Section

Identification Module

NCT ID

Results Section

No data available

No data is available for this block.

Annotation Section

No data available

No data is available for this block.

Document Section

No data available

No data is available for this block.

Derived Section

Miscellaneous Info Module

Version Holder

Status Module

Record Verification Date

Jan 2016

Overall Recruitment Status or Expanded Access Status

Completed

Last Known Status

Not provided

Delayed Posting

Not provided

Why Stopped

Not provided

Expanded Access Info

Start Date

Jul 2008

Primary Completion Date

Aug 2015Actual

Completion Date

Aug 2015Actual

First Submitted Date

Sep 21, 2008

First Submission Date that Met QC Criteria

Sep 22, 2008

First Posted Date

Sep 23, 2008Estimated

Results Waived

Not provided

Results First Submitted Date

Not provided

Results First Submitted that Met QC Criteria

Not provided

Results First Posted Date

Not provided

Certification/Extension (aka Delayed Results) First Submitted Date

Not provided

Certification/Extension First Submitted that Passed QC Review

Not provided

Certification/Extension First Posted Date

Not provided

Last Update Submitted Date

Jan 24, 2016

Last Update Posted Date

Jan 26, 2016Estimated

Sponsor/Collaborators Module

Responsible Party, by Official Title

Dr. Christiane I. Falkner-Radler, MD, The Ludwig Boltzmann Institute of Retinology and Biomicroscopic Laser SurgeryPrincipal Investigator

Lead Sponsor

The Ludwig Boltzmann Institute of Retinology and Biomicroscopic Laser SurgeryOTHER

Collaborators

Not provided

Oversight Module

Has Data Monitoring Committee (DMC)

Is FDA Regulated Drug

Not provided

Is FDA Regulated Device

Not provided

Is Unapproved Device

Not provided

Pediatric Postmarket Surveillance of a Device Product

Not provided

Product Exported from US

Not provided

FDAAA801 Violation

Not provided

Description Module

Brief Summary

Membraneppeling alone versus Membranepeeling with Membrane Limitans Interna Pelling using two different Dyes for Epiretinal Membrane Surgery.

Detailed Description

Not provided

Design Module

Study Type

Interventional

Number of References to an Expanded Access Study

Not provided

Expanded Access Types

Not provided

Patient Registry

Not provided

Target Follow-Up Duration

Not provided

Phases

Not Applicable

Interventional Study Design

Allocation

Biospecimen

No data available

No data is available for this block.

Enrollment

60Actual

Arms/Interventions Module

Arm Groups

Label	Type	Description	Intervention Names
Group 1	Active Comparator	Trypan Blue	Procedure: Trypan Blue
Group 2	Active Comparator	Brillant Blue	Procedure: Brillant Blue

Interventions

Name	Type	Description	Arm Group Labels	Other Names
Trypan Blue	Procedure	Membranepeeling with TB	Group 1
Brillant Blue

Outcomes Module

Primary Outcomes

Measure	Description	Time Frame
Visual acuity		3 months

Secondary Outcomes

Measure	Description	Time Frame
Microperimetry optical coherence tomographie questionnaire (metamorphopsien)		3 months

Other Outcomes

Not provided

Eligibility Module

Eligibility Criteria

Inclusion Criteria:

Idiopathic eperetinal membranes
Phakic or pseudophakic eyes
Age over 60 years

Exclusion Criteria:

Secondary epiretinal membranes
Severe ocular pathologies

Accepts Healthy Volunteers

Yes

Sex

All

Sex/Gender Based

Not provided

Sex/Gender Description

Not provided

Minimum Age

60 Years

Maximum Age

Not provided

Standard Ages

AdultOlder Adult

Study Population

Not provided

Sampling Method

Not provided

Contacts/Locations Module

Central Contacts

Not provided

Overall Officials

Name	Affiliation	Role
Katharina Kreppler, Univ. Doz. Dr.	The Ludwig Boltzmann Institute of Retinology and Biomicroscopic Laser Surgery	Study Chair
Christiane I Falkner-Radler, Dr.	The Ludwig Boltzmann Institute of Retinology and Biomicroscopic Laser Surgery	Principal Investigator

Locations

Facility	Status	City	State	ZIP	Country	Contacts
The Ludwig Boltzmann Institute of Retinology and Biomicroscopic Laser Surgery		Vienna	State of Vienna	1030	Austria

Condition Browse Module

MeSH Terms

ID	Term
D019773	Epiretinal Membrane

Ancestor Terms

ID	Term
D012164	Retinal Diseases
D005128	Eye Diseases

Browse Leaves

Not provided

Browse Branches

Not provided

Intervention Browse Module

MeSH Terms

ID	Term
D014343	Trypan Blue
C032467	procion brilliant blue HGR

Ancestor Terms

ID	Term
D001391	Azo Compounds
D009930	Organic Chemicals
D009282	Naphthalenesulfonates
D009281	Naphthalenes

Browse Leaves

Not provided

Browse Branches

Not provided