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Brilliant Blue Versus Indocyanine Green

Primary Purpose

Macular Pucker, Macular Hole, Vitreoretinal Surgery

Status

Unknown status

Phase

Phase 3

Locations

Germany

Study Type

Interventional

Intervention

Indocyanine green

Brilliant blue arm

About this trial

This is an interventional treatment trial for Macular Pucker focused on measuring dye, internal limiting membrane, macular hole, macular pucker

Eligibility Criteria

50 Years - undefined (Adult, Older Adult)All SexesDoes not accept healthy volunteers

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

Sites / Locations

Center of Ophthalmology, University of CologneRecruiting

Arms of the Study

Arm 1

Arm 2

Arm Type

Active Comparator

Arm Label

Indocyanine green arm

Brilliant blue

Arm Description

Outcomes

Primary Outcome Measures

Best corrected far visual acuity (ETDRS)

Secondary Outcome Measures

Reading ability (Radner)

Optical coherence tomography

Full Information

NCT ID

NCT01083004

First Posted

March 8, 2010

Last Updated

April 15, 2011

Sponsor

University of Cologne

1. Study Identification

Unique Protocol Identification Number

NCT01083004

Brief Title

Brilliant Blue Versus Indocyanine Green

Official Title

A Randomized Study Comparing Brilliant Blue and Indocyanine Green as Intravitreal Dye in Macular Pucker and Macular Hole

Study Type

Interventional

2. Study Status

Record Verification Date

October 2007

Overall Recruitment Status

Unknown status

Study Start Date

January 2008 (undefined)

Primary Completion Date

May 2011 (Anticipated)

Study Completion Date

undefined (undefined)

3. Sponsor/Collaborators

Name of the Sponsor

University of Cologne

4. Oversight

5. Study Description

Brief Summary

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

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study

Macular Pucker, Macular Hole, Vitreoretinal Surgery

Keywords

dye, internal limiting membrane, macular hole, macular pucker

7. Study Design

Primary Purpose

Treatment

Study Phase

Phase 3

Interventional Study Model

Parallel Assignment

Masking

None (Open Label)

Allocation

Randomized

Enrollment

50 (Anticipated)

8. Arms, Groups, and Interventions

Arm Title

Indocyanine green arm

Arm Type

Active Comparator

Arm Title

Brilliant blue

Arm Type

Active Comparator

Intervention Type

Procedure

Intervention Name(s)

Indocyanine green

Intervention Description

Using indocyanine green as intraoperative dye

Intervention Type

Procedure

Intervention Name(s)

Brilliant blue arm

Intervention Description

Using brilliant blue as intraoperative dye

Primary Outcome Measure Information:

Title

Best corrected far visual acuity (ETDRS)

Time Frame

1 year postoperative

Secondary Outcome Measure Information:

Title

Reading ability (Radner)

Time Frame

1 Year

Title

Optical coherence tomography

Time Frame

1 year

10. Eligibility

Sex

All

Minimum Age & Unit of Time

50 Years

Accepts Healthy Volunteers

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

Central Contact Person:

First Name & Middle Initial & Last Name or Official Title & Degree

Albert Caramoy, MD

Phone

004902214784308

acaramoy@yahoo.co.uk

Overall Study Officials:

First Name & Middle Initial & Last Name & Degree

Bernd Kirchhof, MD

Organizational Affiliation

University of Cologne, Center of Ophthalmology, 50924 Cologne, Germany

Official's Role

Principal Investigator

Facility Information:

Facility Name

Center of Ophthalmology, University of Cologne

City

Cologne

State/Province

NRW

ZIP/Postal Code

50924

Country

Germany

Individual Site Status

Recruiting

Facility Contact:

First Name & Middle Initial & Last Name & Degree

Albert Caramoy, MD

Phone

004902214784308

acaramoy@yahoo.co.uk

First Name & Middle Initial & Last Name & Degree

Albert Caramoy, MD

First Name & Middle Initial & Last Name & Degree

Bernd Kirchhof, MD

12. IPD Sharing Statement

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Brilliant Blue Versus Indocyanine Green

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