NCT01083004

Brief Summary

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

Trial Health

55
Monitor

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
50

participants targeted

Target at below P25 for phase_3

Geographic Reach
1 country

1 active site

Status
unknown

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

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Study Timeline

Key milestones and dates

Study Start

First participant enrolled

January 1, 2008

Completed
2.2 years until next milestone

First Submitted

Initial submission to the registry

March 8, 2010

Completed
1 day until next milestone

First Posted

Study publicly available on registry

March 9, 2010

Completed
1.1 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

May 1, 2011

Completed
Last Updated

April 18, 2011

Status Verified

October 1, 2007

Enrollment Period

3.3 years

First QC Date

March 8, 2010

Last Update Submit

April 15, 2011

Conditions

Macular PuckerMacular HoleVitreoretinal Surgery

Keywords

dyeinternal limiting membranemacular holemacular pucker

Outcome Measures

Primary Outcomes (1)

  • Best corrected far visual acuity (ETDRS)

    1 year postoperative

Secondary Outcomes (2)

  • Reading ability (Radner)

    1 Year

  • Optical coherence tomography

    1 year

Study Arms (2)

Indocyanine green arm

ACTIVE COMPARATOR
Procedure: Indocyanine green

Brilliant blue

ACTIVE COMPARATOR
Procedure: Brilliant blue arm

Interventions

Indocyanine greenPROCEDURE

Using indocyanine green as intraoperative dye

Indocyanine green arm
Brilliant blue armPROCEDURE

Using brilliant blue as intraoperative dye

Brilliant blue

Eligibility Criteria

Age50 Years+
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • 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

You may not qualify if:

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

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Center of Ophthalmology, University of Cologne

Cologne, North Rhine-Westphalia, 50924, Germany

RECRUITING

MeSH Terms

Conditions

Epiretinal MembraneRetinal Perforations

Interventions

Indocyanine Green

Condition Hierarchy (Ancestors)

Retinal DiseasesEye Diseases

Intervention Hierarchy (Ancestors)

IndolesHeterocyclic Compounds, 2-RingHeterocyclic Compounds, Fused-RingHeterocyclic Compounds

Study Officials

  • Bernd Kirchhof, MD

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

    PRINCIPAL INVESTIGATOR

Central Study Contacts

Albert Caramoy, MD

CONTACT

004902214784308acaramoy@yahoo.co.uk

Study Design

Study Type
interventional
Phase
phase 3
Allocation
RANDOMIZED
Masking
NONE
Purpose
TREATMENT
Intervention Model
PARALLEL
Sponsor Type
OTHER

Study Record Dates

First Submitted

March 8, 2010

First Posted

March 9, 2010

Study Start

January 1, 2008

Primary Completion

May 1, 2011

Last Updated

April 18, 2011

Record last verified: 2007-10

Locations

DE(1)