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

This study has been completed.
Sponsor:
ClinicalTrials.gov Identifier:
NCT00437593
First Posted: February 21, 2007
Last Update Posted: September 23, 2008
The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
Information provided by:
The Ludwig Boltzmann Institute of Retinology and Biomicroscopic Laser Surgery
  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: Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)
Primary Purpose: Diagnostic
Official Title: UHR-OCT and HD-OCT for Preretinal Membranes: Is There a Difference Between ICG and Membrane Blue? A Randomized Clinical Trial

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 ]
  • Distance Visual acuity [ Time Frame: 12 months ]
  • Near Visual acuity [ Time Frame: 12 months ]
  • Contrast sensitivtiy [ Time Frame: 12 months ]

Secondary Outcome Measures:
  • OCT Stratus 3000 [ Time Frame: 12 months ]
  • Visual Field [ Time Frame: 12 months ]

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:
    Procedure: ppVE, MP, ICG
    surgery with ILM staining
    Procedure: ppVE, MP, MB
    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

Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years to 85 Years   (Adult, Senior)
Sexes Eligible for Study:   All
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
Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): 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

Responsible Party: Binder Susanne, Univ. Prof. Dr, The Ludwig Boltzmann Institute of Retinology and Biomicroscopic Laser Surgery
ClinicalTrials.gov Identifier: NCT00437593     History of Changes
Other Study ID Numbers: FR-2-CI-2007
First Submitted: February 19, 2007
First Posted: February 21, 2007
Last Update Posted: September 23, 2008
Last Verified: December 2007

Keywords provided by The Ludwig Boltzmann Institute of Retinology and Biomicroscopic Laser Surgery:
preretinal membrane
vitrectomy
uhr-oct
hd-oct

Additional relevant MeSH terms:
Retinal Diseases
Epiretinal Membrane
Eye Diseases