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

This study has been completed.
Sponsor:
Information provided by:
The Ludwig Boltzmann Institute of Retinology and Biomicroscopic Laser Surgery
ClinicalTrials.gov Identifier:
NCT00437593
First received: February 19, 2007
Last updated: September 21, 2008
Last verified: December 2007
History of Changes
  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
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Parallel Assignment
Masking: 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

Resource links provided by NLM:

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:
    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

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: 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
Study First Received: February 19, 2007
Last Updated: September 21, 2008
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:
Retinal Diseases
Epiretinal Membrane
Eye Diseases

ClinicalTrials.gov processed this record on May 23, 2013