Brilliant Blue Versus Indocyanine Green

NCT ID: NCT01083004

Last Updated: 2011-04-18

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

UNKNOWN

Clinical Phase

PHASE3

Total Enrollment

50 participants

Study Classification

INTERVENTIONAL

Study Start Date

2008-01-31

Brief Summary

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

Detailed Description

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Conditions

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Macular Pucker Macular Hole Vitreoretinal Surgery

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

TREATMENT

Blinding Strategy

NONE

Study Groups

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Indocyanine green arm

Group Type ACTIVE_COMPARATOR

Indocyanine green

Intervention Type PROCEDURE

Using indocyanine green as intraoperative dye

Brilliant blue

Group Type ACTIVE_COMPARATOR

Brilliant blue arm

Intervention Type PROCEDURE

Using brilliant blue as intraoperative dye

Interventions

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Indocyanine green

Using indocyanine green as intraoperative dye

Intervention Type PROCEDURE

Brilliant blue arm

Using brilliant blue as intraoperative dye

Intervention Type PROCEDURE

Eligibility Criteria

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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
Minimum Eligible Age

50 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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University of Cologne

OTHER

Sponsor Role lead

Responsible Party

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University of Cologne

Principal Investigators

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Bernd Kirchhof, MD

Role: PRINCIPAL_INVESTIGATOR

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

Locations

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Center of Ophthalmology, University of Cologne

Cologne, North Rhine-Westphalia, Germany

Site Status RECRUITING

Countries

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Germany

Central Contacts

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Albert Caramoy, MD

Role: CONTACT

004902214784308

Facility Contacts

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Albert Caramoy, MD

Role: primary

004902214784308

Other Identifiers

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BlueIce001

Identifier Type: -

Identifier Source: org_study_id

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