Indocyanine Green or Trypan Blue for Delamination of the Internal Limiting Membrane in Macular Hole Surgery
Idiopathic Macular Hole
Procedure: Delamination of the Internal limiting membrane
|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|
- 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 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.
|Study Start Date:||April 2003|
|Estimated Study Completion Date:||January 2005|
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.
Please refer to this study by its ClinicalTrials.gov identifier: NCT00419185
|Eye Clinic, University Schleswig-Holstein, Campus Lübeck|
|Lübeck, Schleswig-Holstein, Germany, 23538|
|Principal Investigator:||Hans M Hoerauf, Prof.||Eye Clinic, University Schleswig Holstein, Campus Lübeck|