UHR-OCT and HD-OCT for Preretinal Membranes: ICG Versus Membrane Blue - Full Text View

Sponsor:	The Ludwig Boltzmann Institute of Retinology and Biomicroscopic Laser Surgery
Information provided by:	The Ludwig Boltzmann Institute of Retinology and Biomicroscopic Laser Surgery
ClinicalTrials.gov Identifier:	NCT00437593

Purpose

Using the UHR-OCT and HD-OCT to evaluate early postoperative changes in patients with diagnosis preretinal membrane after successfully performed pars-plana vitrectomy and membrane peeling with two different types of dyes.

Condition	Intervention
Retinal Diseases	Procedure: ppVE, MP, ICG Procedure: ppVE, MP, MB

Study Type:	Interventional
Study Design:	Diagnostic, Randomized, Open Label, Active Control, Parallel Assignment, Safety/Efficacy Study
Official Title:	UHR-OCT and HD-OCT for Preretinal Membranes: Is There a Difference Between ICG and Membrane Blue? A Randomized Clinical Trial

Resource links provided by NLM:

MedlinePlus related topics: Retinal Disorders

U.S. FDA Resources

Further study details as provided by The Ludwig Boltzmann Institute of Retinology and Biomicroscopic Laser Surgery:

Primary Outcome Measures:

UHR-OCT HD-OCT [ Time Frame: 12 months ] [ Designated as safety issue: Yes ]
Distance Visual acuity [ Time Frame: 12 months ] [ Designated as safety issue: Yes ]
Near Visual acuity [ Time Frame: 12 months ] [ Designated as safety issue: Yes ]
Contrast sensitivtiy [ Time Frame: 12 months ] [ Designated as safety issue: Yes ]

Secondary Outcome Measures:

OCT Stratus 3000 [ Time Frame: 12 months ] [ Designated as safety issue: Yes ]
Visual Field [ Time Frame: 12 months ] [ Designated as safety issue: Yes ]

Estimated Enrollment:	20
Study Start Date:	September 2005
Study Completion Date:	May 2008
Primary Completion Date:	May 2008 (Final data collection date for primary outcome measure)

Intervention Details:

surgery with ILM staining

Surgery with ERM staining

Detailed Description:

Surgical procedures performed are pars-plana vitrectomy and membrane peeling with or without cataract extraction and IOL implantation. The type of the dyes is randomized. The study is designed to include a total of tweny cases (10 cases with ICG and 10 cases with Membrane blue)

Main outcome measures are:

UHR-OCT, HD-OCT distance and near visual acuity and contrast sensitivity amsler grid secondary outcome measures are: OCT Stratus 3000 and visual field. Clinical examinations: preoperative, and follow-up examinations after 1 week, 1 months, 3 months, 6 months and 12 months.

Eligibility

Ages Eligible for Study:	18 Years to 85 Years
Genders Eligible for Study:	Both
Accepts Healthy Volunteers:	Yes

Criteria

Inclusion Criteria:

Preretinal membrane
Age between 18 and 85 years
Combined surgery possible(phacoemulsification and vitreoretinal procedure)

Exclusion Criteria:

Age-related macular degeneration
Previous retinal detachment surgery
Previous laser treatment

Contacts and Locations

Please refer to this study by its ClinicalTrials.gov identifier: NCT00437593

Locations

Austria
Rudolf Foundation Clinic
Vienna, Austria, 1030

Sponsors and Collaborators

The Ludwig Boltzmann Institute of Retinology and Biomicroscopic Laser Surgery

Investigators

Study Chair:

Susanne Binder, MD

Ludwig Boltzmann Institue for Retinology and Biomicroscopic Lasersurgery

More Information

No publications provided

Responsible Party:	The Ludwig Boltzmann Institute of Retinology and Biomicroscopic Laser Surgery ( Binder Susanne, Univ. Prof. Dr )
Study ID Numbers:	FR-2-CI-2007
Study First Received:	February 19, 2007
Last Updated:	September 21, 2008
ClinicalTrials.gov Identifier:	NCT00437593 History of Changes
Health Authority:	Austria: Ethikkommission

Keywords provided by The Ludwig Boltzmann Institute of Retinology and Biomicroscopic Laser Surgery:

preretinal membrane
vitrectomy
uhr-oct
hd-oct

Additional relevant MeSH terms:

Eye Diseases
Epiretinal Membrane
Retinal Diseases

ClinicalTrials.gov processed this record on February 08, 2010