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

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ClinicalTrials.gov Identifier: NCT00437593
Recruitment Status : Completed
First Posted : February 21, 2007
Last Update Posted : September 23, 2008
Sponsor:
Information provided by:
The Ludwig Boltzmann Institute of Retinology and Biomicroscopic Laser Surgery

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.

Condition or disease Intervention/treatment Phase
Retinal Diseases Procedure: ppVE, MP, ICG Procedure: ppVE, MP, MB Not Applicable

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 Type : Interventional  (Clinical Trial)
Estimated Enrollment : 20 participants
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
Study Start Date : September 2005
Actual Primary Completion Date : May 2008
Actual Study Completion Date : May 2008

Intervention Details:
  • Procedure: ppVE, MP, ICG
    surgery with ILM staining
  • Procedure: ppVE, MP, MB
    Surgery with ERM staining


Primary Outcome Measures :
  1. UHR-OCT HD-OCT [ Time Frame: 12 months ]
  2. Distance Visual acuity [ Time Frame: 12 months ]
  3. Near Visual acuity [ Time Frame: 12 months ]
  4. Contrast sensitivtiy [ Time Frame: 12 months ]

Secondary Outcome Measures :
  1. OCT Stratus 3000 [ Time Frame: 12 months ]
  2. Visual Field [ Time Frame: 12 months ]


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Ages Eligible for Study:   18 Years to 85 Years   (Adult, Older Adult)
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

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

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 Posted: February 21, 2007    Key Record Dates
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