NCT00757380

Brief Summary

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

Trial Health

87
On Track

Trial Health Score

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

Enrollment
60

participants targeted

Target at P25-P50 for not_applicable

Timeline
Completed

Started Jul 2008

Longer than P75 for not_applicable

Geographic Reach
1 country

1 active site

Status
completed

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

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

July 1, 2008

Completed
3 months until next milestone

First Submitted

Initial submission to the registry

September 21, 2008

Completed
2 days until next milestone

First Posted

Study publicly available on registry

September 23, 2008

Completed
6.9 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

August 1, 2015

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

August 1, 2015

Completed
Last Updated

January 26, 2016

Status Verified

January 1, 2016

Enrollment Period

7.1 years

First QC Date

September 21, 2008

Last Update Submit

January 24, 2016

Conditions

Idiopathic Epiretinal Membranes

Keywords

epiretinal membranesvitreoretinal dyesmembranepeeling

Outcome Measures

Primary Outcomes (1)

  • Visual acuity

    3 months

Secondary Outcomes (1)

  • Microperimetry optical coherence tomographie questionnaire (metamorphopsien)

    3 months

Study Arms (2)

Group 1

ACTIVE COMPARATOR

Trypan Blue

Procedure: Trypan Blue

Group 2

ACTIVE COMPARATOR

Brillant Blue

Procedure: Brillant Blue

Interventions

Trypan BluePROCEDURE

Membranepeeling with TB

Group 1
Brillant BluePROCEDURE

Membranepeeling and membrana limitans interna peeling with BB

Group 2

Eligibility Criteria

Age60 Years+
Sexall
Healthy VolunteersYes
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • Idiopathic eperetinal membranes
  • Phakic or pseudophakic eyes
  • Age over 60 years

You may not qualify if:

  • Secondary epiretinal membranes
  • Severe ocular pathologies

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

The Ludwig Boltzmann Institute of Retinology and Biomicroscopic Laser Surgery

Vienna, Vienna, 1030, Austria

Location

MeSH Terms

Conditions

Epiretinal Membrane

Interventions

Trypan Blueprocion brilliant blue HGR

Condition Hierarchy (Ancestors)

Retinal DiseasesEye Diseases

Intervention Hierarchy (Ancestors)

Azo CompoundsOrganic ChemicalsNaphthalenesulfonatesNaphthalenesPolycyclic Aromatic HydrocarbonsHydrocarbons, AromaticHydrocarbons, CyclicHydrocarbonsArylsulfonatesArylsulfonic AcidsSulfonic AcidsSulfur AcidsSulfur CompoundsPolycyclic Compounds

Study Officials

  • 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

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
SINGLE
Who Masked
OUTCOMES ASSESSOR
Purpose
TREATMENT
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
MD

Study Record Dates

First Submitted

September 21, 2008

First Posted

September 23, 2008

Study Start

July 1, 2008

Primary Completion

August 1, 2015

Study Completion

August 1, 2015

Last Updated

January 26, 2016

Record last verified: 2016-01

Locations

AU(1)