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Clinical Trials |

Internal Limiting Membrane Peeling With Indocyanine Green or Trypan Blue in Macular Hole Surgery:  A Randomized Trial

Julia Beutel, MD; Gerlinde Dahmen, MSc; Andreas Ziegler, PhD; Hans Hoerauf, MD
Arch Ophthalmol. 2007;125(3):326-332. doi:10.1001/archopht.125.3.326.
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Objective  To report on anatomical and visual outcomes after vitrectomy and internal limiting membrane peeling for idiopathic macular hole repair.

Methods  Forty patients with stage II to IV idiopathic macular holes were randomly assigned (1:1) in a 2-arm, single-center, randomized controlled . Internal limiting membrane delamination was performed using indocyanine green (ICG) solution (n = 20) or trypan blue (TB) (n = 20). Two patients did not complete the study, for a total of 19 in each group. Follow-up examinations included Early Treatment of Diabetic Retinopathy Study visual acuity, scanning laser ophthalmoscope microperimetry, optical coherence tomography, and fluorescein angiography.

Main Outcome Measure  Visual acuity 3 months after surgery.

Results  Visual acuity did not show a significant difference between study groups (95% confidence interval [CI], −2 to 1 lines). The rate of macular hole closures was identical (84%; 95% CI, 60% to 97%). Within-group visual recovery was significant only in the TB group. Central scotomata despite hole closure persisted in 8 patients (42%) in the ICG group and in 5 (26%) in the TB group.

Conclusion  Although no statistically significant difference was detected for the primary end point, the better visual recovery in the TB group and the higher rate of persistent central scotomata in the ICG group justify a larger clinical trial.

Application to Clinical Practice  No statistically significant difference in visual acuity between ICG and TB in the used concentrations and application method could be proved in macular hole surgery.

Trial Registration  clinicaltrials.gov Identifier: "http://clinicaltrials.gov/show/NCT00419185"

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Figure 1.

Participant flowchart for each treatment group. ICG indicates indocyanine green; TB, trypan blue.

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Figure 2.

Visual acuity (VA) results for each treatment group at 3 and 6 months compared with preoperative values. Horizontal bars represent median values; boxes, 25th and 75th percentiles; and whiskers, minimum and maximum values. ETDRS indicates Early Treatment of Diabetic Retinopathy Study; ICG, indocyanine green; TB, trypan blue.

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Figure 3.

Fluorescein angiograms (late phase) of a patient in the indocyanine green group before surgery showing central hyperfluorescence due to a stage II macular hole (A) and 6 months after successful macular hole closure revealing perimacular cystoid changes (arrow) (B).

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Figure 4.

Optical coherence tomographs of a patient in the trypan blue group before surgery showing a stage III macular hole with an operculum (A) and 3 months after surgery showing a small dehiscence between the retinal pigment epithelium and the retinal layers (arrow) (B).

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