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

Tracking Information

First Received Date ^ICMJE

February 19, 2007

Last Updated Date

September 21, 2008

Start Date ^ICMJE

September 2005

Primary Completion Date

May 2008 (final data collection date for primary outcome measure)

Current Primary Outcome Measures ^ICMJE

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 ]

Original Primary Outcome Measures ^ICMJE

UHR-OCT
Distance Visual acuity
Near Visual acuity
Contrast sensitivtiy

Change History

Complete list of historical versions of study NCT00437593 on ClinicalTrials.gov Archive Site

Current Secondary Outcome Measures ^ICMJE

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

Original Secondary Outcome Measures ^ICMJE

OCT Stratus 3000
Visual Field

Descriptive Information

Brief Title ^ICMJE

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

Official Title ^ICMJE

UHR-OCT and HD-OCT for Preretinal Membranes: Is There a Difference Between ICG and Membrane Blue? A Randomized Clinical Trial

Brief Summary

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.

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.

Study Phase

Study Type ^ICMJE

Interventional

Study Design ^ICMJE

Diagnostic, Randomized, Open Label, Active Control, Parallel Assignment, Safety/Efficacy Study

Condition ^ICMJE

Retinal Diseases

Intervention ^ICMJE

Procedure: ppVE, MP, ICG
Procedure: ppVE, MP, MB

Study Arms / Comparison Groups

Publications *

* Includes publications given by the data provider as well as publications identified by National Clinical Trials Identifier (NCT ID) in Medline.

Recruitment Information

Recruitment Status ^ICMJE

Completed

Estimated Enrollment ^ICMJE

Completion Date

May 2008

Primary Completion Date

May 2008 (final data collection date for primary outcome measure)

Eligibility Criteria ^ICMJE

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

Gender

Both

Ages

18 Years to 85 Years

Accepts Healthy Volunteers

Yes

Contacts ^ICMJE

Contact information is only displayed when the study is recruiting subjects

Location Countries ^ICMJE

Austria

Administrative Information

NCT ID ^ICMJE

NCT00437593

Responsible Party

Binder Susanne, Univ. Prof. Dr, The Ludwig Boltzmann Institute of Retinology and Biomicroscopic Laser Surgery

Study ID Numbers ^ICMJE

FR-2-CI-2007

Study Sponsor ^ICMJE

The Ludwig Boltzmann Institute of Retinology and Biomicroscopic Laser Surgery

Collaborators ^ICMJE

Investigators ^ICMJE

Study Chair:

Susanne Binder, MD

Ludwig Boltzmann Institue for Retinology and Biomicroscopic Lasersurgery

Information Provided By

The Ludwig Boltzmann Institute of Retinology and Biomicroscopic Laser Surgery

Verification Date

December 2007

^ICMJE Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP