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Albert Caramoy, Bernd Kirchhof, Moritz Hahn, Sabine Schröder, Sascha Fauser, Philipp S. Muether; Randomized Staining with Brilliant Blue or Indocyanine Green in Macular Hole and Pucker Surgery. Invest. Ophthalmol. Vis. Sci. 2011;52(14):4500.
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© ARVO (1962-2015); The Authors (2016-present)
To report visual outcome after vitrectomy and internal limiting membrane (ILM) peeling using either indocyanine green (ICG) or brilliant blue (BB).
Patients with idiopathic macular hole or macular pucker were randomly assigned (1:1) into a single center, single surgeon, non-inferiority study assessing ICG or BB as intravitreal ILM-dye. Follow up examination included Early Treatment Diabetic Retinopathy Study (ETDRS) visual acuity, reading (Radner) visual acuity, clinical examinations, and optical coherence tomography. Main outcome measure was 1 year far and reading visual acuity. Non-inferiority margin was set at Δ=0.3.
47 eyes were included in the analysis. In macular hole both far visual acuity (VA) and reading VA changes after 1 year do not show relevant differences (95% confidence interval (CI) -0.16 to 0,1 LogMAR and CI -0.33 to 0.11 LogRAD, respectively). In macular pucker VA changes for BB are inferior for reading VA, but not for far VA (CI -0.27 to 0.07 LogMAR and CI -0.29 to 0.38 LogRAD). Adverse events included macular hole persistence in 1 case and macular edema in 3 cases.
No relevant difference between BB and ICG was detected for eyes with macular hole. For eyes with macular pucker BB was inferior to ICG in this study. The results justify a larger clinical trial.
Clinical Trial: :
http://www.clinicaltrials.gov NCT 01083004
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