Trypan Blue Versus Brillant Blue for Epiretinal Membranes

• Sponsor: The Ludwig Boltzmann Institute of Retinology and Biomicroscopic Laser Surgery (Other)
• Overall Status: Completed
• CT.gov ID: NCT00757380
• Collaborator: (none)
• Enrollment: 60
• Location: 1
• Arms: 2
• Duration (Months): 85
• Patients Per Site Per Month: 0.7

Study Details

Study Description

Brief Summary

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

Condition or Disease	Intervention/Treatment	Phase
Idiopathic Epiretinal Membranes	Procedure: Trypan Blue; Procedure: Brillant Blue	N/A

Study Design

• Study Type: Interventional
• Actual Enrollment: 60 participants
• Allocation: Randomized
• Intervention Model: Parallel Assignment
• Masking: Single (Outcomes Assessor)
• Primary Purpose: Treatment
• Official Title: Membranepeeling With Trypan Blue Versus Membranpeeling With Brillant Blue for Patients With Idiopathic Epiretinal Membranes
• Study Start Date: Jul 1, 2008
• Actual Primary Completion Date: Aug 1, 2015
• Actual Study Completion Date: Aug 1, 2015

Arms and Interventions

Arm	Intervention/Treatment
Active Comparator: Group 1 Trypan Blue	Procedure: Trypan Blue; Membranepeeling with TB
Active Comparator: Group 2 Brillant Blue	Procedure: Brillant Blue; Membranepeeling and membrana limitans interna peeling with BB

Outcome Measures

Primary Outcome Measures

1. Visual acuity [3 months]

Secondary Outcome Measures

1. Microperimetry optical coherence tomographie questionnaire (metamorphopsien) [3 months]

Eligibility Criteria

Criteria

• Ages Eligible for Study: 60 Years and Older
• Sexes Eligible for Study: All
• Accepts Healthy Volunteers: Yes

Inclusion Criteria:

• Idiopathic eperetinal membranes

• Phakic or pseudophakic eyes

• Age over 60 years

Exclusion Criteria:

• Secondary epiretinal membranes

• Severe ocular pathologies

Contacts and Locations

Locations

	Site	City	State	Country	Postal Code
1	The Ludwig Boltzmann Institute of Retinology and Biomicroscopic Laser Surgery	Vienna		Austria	1030

Sponsors and Collaborators

• The Ludwig Boltzmann Institute of Retinology and Biomicroscopic Laser Surgery

Investigators

• Study Chair: Katharina Kreppler, Univ. Doz. Dr., The Ludwig Boltzmann Institute of Retinology and Biomicroscopic Laser Surgery
• Principal Investigator: Christiane I Falkner-Radler, Dr., The Ludwig Boltzmann Institute of Retinology and Biomicroscopic Laser Surgery

Study Documents (Full-Text)

None provided.

More Information

Publications

None provided.

• Responsible Party: Dr. Christiane I. Falkner-Radler, MD, The Ludwig Boltzmann Institute of Retinology and Biomicroscopic Laser Surgery
• ClinicalTrials.gov Identifier: NCT00757380
• Other Study ID Numbers: FR-4-CI-2008
• First Posted: Sep 23, 2008
• Last Update Posted: Jan 26, 2016
• Last Verified: Jan 1, 2016

• Keywords provided by Dr. Christiane I. Falkner-Radler, MD, The Ludwig Boltzmann Institute of Retinology and Biomicroscopic Laser Surgery: epiretinal membranes; vitreoretinal dyes; membranepeeling
• Additional relevant MeSH terms: Epiretinal Membrane; Diminazene aceturate

Study Results

No Results Posted as of Jan 26, 2016