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

February 19, 2007
September 21, 2008
September 2005
May 2008   (final data collection date for primary outcome measure)
  • 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 ]
  • UHR-OCT
  • Distance Visual acuity
  • Near Visual acuity
  • Contrast sensitivtiy
Complete list of historical versions of study NCT00437593 on ClinicalTrials.gov Archive Site
  • OCT Stratus 3000 [ Time Frame: 12 months ] [ Designated as safety issue: Yes ]
  • Visual Field [ Time Frame: 12 months ] [ Designated as safety issue: Yes ]
  • OCT Stratus 3000
  • Visual Field
Not Provided
Not Provided
 
UHR-OCT and HD-OCT for Preretinal Membranes: ICG Versus Membrane Blue
UHR-OCT and HD-OCT for Preretinal Membranes: Is There a Difference Between ICG and Membrane Blue? A Randomized Clinical Trial

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.

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.

Interventional
Not Provided
Allocation: Randomized
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Parallel Assignment
Masking: Open Label
Primary Purpose: Diagnostic
Retinal Diseases
  • Procedure: ppVE, MP, ICG
    surgery with ILM staining
  • Procedure: ppVE, MP, MB
    Surgery with ERM staining
Not Provided
Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Completed
20
May 2008
May 2008   (final data collection date for primary outcome measure)

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
Both
18 Years to 85 Years
Yes
Contact information is only displayed when the study is recruiting subjects
Austria
 
NCT00437593
FR-2-CI-2007
No
Binder Susanne, Univ. Prof. Dr, The Ludwig Boltzmann Institute of Retinology and Biomicroscopic Laser Surgery
The Ludwig Boltzmann Institute of Retinology and Biomicroscopic Laser Surgery
Not Provided
Study Chair: Susanne Binder, MD Ludwig Boltzmann Institue for Retinology and Biomicroscopic Lasersurgery
The Ludwig Boltzmann Institute of Retinology and Biomicroscopic Laser Surgery
December 2007

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