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A Randomized Trial

Julia Beutel, MD; Gerlinde Dahmen, MSc; Andreas Ziegler, PhD; Hans Hoerauf, MD

Arch Ophthalmol. 2007;125(3):326-332.

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: NCT00419185

Author Affiliations: University Eye Clinic (Drs Beutel and Hoerauf) and Institute for Medical Biometry and Statistics (Drs Dahmen and Ziegler), University Hospital Schleswig-Holstein, Campus Lübeck, University at Lübeck, Lübeck, Germany. Dr Hoerauf is now at the University Eye Clinic, Georg-August-University Göttingen, Göttingen, Germany.

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