Brilliant Blue Versus Indocyanine Green | NCT01083004

Studies
Brilliant Blue Versus Indocyanine Green

NCT01083004

Sponsor

University of Cologne

Status

Unknown status

Last Update Posted

Apr 18, 2011Estimated

Enrollment

50Estimated

Phase

Phase 3

Conditions

Macular Pucker
Macular Hole
Vitreoretinal Surgery

Interventions

Indocyanine green
Brilliant blue arm

Countries

Germany

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

Oct 2007

Overall Recruitment Status or Expanded Access Status

Unknown status

Last Known Status

Recruiting

Delayed Posting

Not provided

Why Stopped

Not provided

Expanded Access Info

Start Date

Jan 2008

Primary Completion Date

May 2011Estimated

Completion Date

Not provided

First Submitted Date

Mar 8, 2010

First Submission Date that Met QC Criteria

Mar 8, 2010

First Posted Date

Mar 9, 2010Estimated

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

Apr 15, 2011

Last Update Posted Date

Apr 18, 2011Estimated

Description Module

Brief Summary

A study of non-inferiority design comparing brilliant blue and indocyanine green as intraoperative dye in macular pucker and macular hole.

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

Phase 3

Interventional Study Design

Allocation

Biospecimen

No data available

No data is available for this block.

Enrollment

50Estimated

Arms/Interventions Module

Arm Groups

Label	Type	Description	Intervention Names
Indocyanine green arm	Active Comparator		Procedure: Indocyanine green
Brilliant blue	Active Comparator		Procedure: Brilliant blue arm

Interventions

Name	Type	Description	Arm Group Labels	Other Names
Indocyanine green	Procedure	Using indocyanine green as intraoperative dye	Indocyanine green arm

Outcomes Module

Primary Outcomes

Measure	Description	Time Frame
Best corrected far visual acuity (ETDRS)		1 year postoperative

Secondary Outcomes

Measure	Description	Time Frame
Reading ability (Radner)		1 Year
Optical coherence tomography		1 year

Other Outcomes

Not provided

Eligibility Module

Eligibility Criteria

Inclusion Criteria:

age over 50
macular pucker or macular hole with subjective disturbances
All phakic or pseudophakic patients
far visual acuity better than 20/400
able to read, understand, and willing to sign the informed consent form

Exclusion Criteria:

any other ocular disease or conditions compromising the visual acuity other than macular hole or macular pucker
prior vitreoretinal surgery in the study eye

Accepts Healthy Volunteers

Sex

All

Sex/Gender Based

Not provided

Sex/Gender Description

Not provided

Minimum Age

50 Years

Maximum Age

Not provided

Standard Ages

AdultOlder Adult

Study Population

Not provided

Sampling Method

Not provided

Contacts/Locations Module

Central Contacts

Name	Role	Phone	Extension	Email
Albert Caramoy, MD	Contact	004902214784308		acaramoy@yahoo.co.uk

Overall Officials

Name	Affiliation	Role
Bernd Kirchhof, MD	University of Cologne, Center of Ophthalmology, 50924 Cologne, Germany	Principal Investigator

Locations

Facility	Status	City	State	ZIP	Country	Contacts
Center of Ophthalmology, University of Cologne	Recruiting	Cologne	North Rhine-Westphalia	50924	Germany

Condition Browse Module

MeSH Terms

ID	Term
D019773	Epiretinal Membrane
D012167	Retinal Perforations

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
D007208	Indocyanine Green

Ancestor Terms

ID	Term
D007211	Indoles
D006574	Heterocyclic Compounds, 2-Ring
D000072471	Heterocyclic Compounds, Fused-Ring
D006571	Heterocyclic Compounds

Browse Leaves

Not provided

Browse Branches

Not provided