Clinical trial NCT00419185: Indocyanine Green or Trypan Blue for Delamination of the Internal Limiting Membrane in Macular Hole Surgery
Official title: Internal Limiting Membrane (ILM)- Peeling With Indocyanine Green or Trypan Blue in Macular Hole Surgery: A Prospective Randomized Trial
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Idiopathic Macular Hole
Keywords: macular hole surgery
indocyanine green
trypan blue
internal limiting membrane
Lead sponsor: University of Luebeck
Sponsor class: OTHER
First posted: 2007-01-08
Enrollment: 40
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief summary: 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.

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 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.

Primary outcomes:
measure: Primary outcome was ETDRS visual acuity (VA: snellen equivalent) at two meters 3 months after surgery.
measure: 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 outcomes:
measure: Secondary outcome measures were successful hole closure defined only as complete closure of the inner retinal dehiscence determined by OCT,
measure: cystoid macular edema as revealed by fluorescein angiography (FLA) and
measure: postoperative scotoma shown by SLO-microperimetry.
Other outcomes:
Locations:
city: Lübeck
country: Germany
facility: Eye Clinic, University Schleswig-Holstein, Campus Lübeck
state: Schleswig-Holstein
Study officials:
affiliation: Eye Clinic, University Schleswig Holstein, Campus Lübeck
name: Hans M Hoerauf, Prof.
role: PRINCIPAL_INVESTIGATOR
References:
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