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
  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:


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
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

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 August 28, 2014