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Indocyanine Green or Trypan Blue for Delamination of the Internal Limiting Membrane in Macular Hole Surgery

This study has been completed.
Sponsor:
Information provided by:
University of Luebeck
ClinicalTrials.gov Identifier:
NCT00419185
First received: January 5, 2007
Last updated: NA
Last verified: January 2007
History: No changes posted
  Purpose

To evaluate the anatomical and visual outcomes after vitrectomy and internal limiting membrane (ILM) peeling with indocyanine green (ICG) or trypan blue (TB) for idiopathic macular hole repair in a prospective randomized trial.


Condition Intervention
Idiopathic Macular Hole
Procedure: Delamination of the Internal limiting membrane

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Efficacy Study
Intervention Model: Parallel Assignment
Masking: Single Blind
Primary Purpose: Treatment
Official Title: Internal Limiting Membrane (ILM)- Peeling With Indocyanine Green or Trypan Blue in Macular Hole Surgery: A Prospective Randomized Trial

Resource links provided by NLM:


Further study details as provided by University of Luebeck:

Primary Outcome Measures:
  • Primary outcome was ETDRS visual acuity (VA: snellen equivalent) at two meters 3 months after surgery.
  • Assignment to ICG or TB dye was performed by the Institute of Medical Biometry and Statistics of the University Luebeck per telephone immediately before surgery. Allocation to treatment arms was done with a permuted block randomization with block size 20

Secondary Outcome Measures:
  • Secondary outcome measures were successful hole closure defined only as complete closure of the inner retinal dehiscence determined by OCT,
  • cystoid macular edema as revealed by fluorescein angiography (FLA) and
  • postoperative scotoma shown by SLO-microperimetry.

Estimated Enrollment: 40
Study Start Date: April 2003
Estimated Study Completion Date: January 2005
Detailed Description:

In several clinical trials the positive effect of inner limiting membrane peeling (ILM) on anatomical and functional outcome in macular hole surgery has been reported. Controversies, however, exist regarding the application and possible toxicity of dyes, facilitating the surgical procedure. Since dyes were introduced for ILM peeling several authors reported on the use of indocyanine green and trypan blue (TB) for membrane peeling or ILM removal. Recent experimental and clinical reports raise concern about the safety of ICG-assisted membrane peeling. Morphological and functional damage was described in an animal model, in human donor eyes, in cultured human pigment epithelial cells and in clinical studies using ICG in macular surgery. The intraocular tolerance of TB has been demonstrated in rabbit eyes and in retinal pigment epithelium cell viability studies. Higher concentrations of TB (0.6 or 4 mg/ml) lead to toxicity on cultured RPE cells, but the application of lower clinically relevant levels did not show any significant effect. A recent retrospective comparative analysis indicates that TB may be the safer dye. They found better anatomical and functional results than with the use of ICG.

Therefore, the aim of this study was to compare the anatomical and functional outcome after dye-assisted peeling of the ILM in patients with idiopathic macular holes using ICG or TB in a prospective and randomized trial.

  Eligibility

Ages Eligible for Study:   18 Years and older
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

  • Patients with idiopathic macular holes stage II-IV according to the classification proposed by Gass and a visual acuity of at least 20/200 entered this study.

Exclusion Criteria:

  • Patients with secondary macular holes, previous intraocular surgery, except for uneventful cataract extraction and patients with ocular disorders that might interfere with vision such as severe cataract, exudative age-related macular degeneration or diabetic retinopathy.
  Contacts and Locations
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Please refer to this study by its ClinicalTrials.gov identifier: NCT00419185

Locations
Germany
Eye Clinic, University Schleswig-Holstein, Campus Lübeck
Lübeck, Schleswig-Holstein, Germany, 23538
Sponsors and Collaborators
University of Luebeck
Investigators
Principal Investigator: Hans M Hoerauf, Prof. Eye Clinic, University Schleswig Holstein, Campus Lübeck
  More Information

Publications:

Additional publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):
ClinicalTrials.gov Identifier: NCT00419185     History of Changes
Other Study ID Numbers: UKSH
Study First Received: January 5, 2007
Last Updated: January 5, 2007
Health Authority: Germany: Ethics Commission

Keywords provided by University of Luebeck:
macular hole surgery
indocyanine green
trypan blue
internal limiting membrane

Additional relevant MeSH terms:
Retinal Perforations
Eye Diseases
Retinal Diseases

ClinicalTrials.gov processed this record on November 25, 2014