NCT00757471

Brief Summary

Macular Hole Surgery with two different Dyes

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 Aug 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

August 1, 2008

Completed
2 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 years

First QC Date

September 21, 2008

Last Update Submit

January 24, 2016

Conditions

Idiopathic Macular Holes

Keywords

Macular hole surgerymembranepeelingclosure ratevitreoretinal dyes

Outcome Measures

Primary Outcomes (1)

  • Macular Hole Closure Rate

    12 Months

Secondary Outcomes (1)

  • Visual Acuity Microperimetry Optical Coherence Tomography

    12 Months

Study Arms (2)

Group 1

ACTIVE COMPARATOR

Brillant Blue

Procedure: Brillant Blue

Group 2

ACTIVE COMPARATOR

Indocyanine Green

Procedure: Indocyanine Green

Interventions

Brillant BluePROCEDURE

Membrane Peeling with Brillant Blue

Group 1
Indocyanine GreenPROCEDURE

Membrane Peeling with indocyanine Green

Group 2

Eligibility Criteria

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

You may qualify if:

  • Idiopathic stage 3 and 4 macular holes
  • Stage 2 macular holes, followed up for at least 6 months
  • Pseudophakic and phakic eyes
  • Age over 60 years

You may not qualify if:

  • Traumatic macular holes
  • Secondary macular holes
  • Severe ocular diseases

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

Interventions

procion brilliant blue HGRIndocyanine Green

Intervention Hierarchy (Ancestors)

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

Study Officials

  • Katharina Kreppler, MD

    The Ludwig Boltzmann Institute of Retinology and Biomicroscopic Laser Surgery

    STUDY CHAIR

  • Christiane I Falkner-Radler, MD

    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

August 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)