Agreement of the Heidelberg Retina Tomograph II macula edema module with fundus biomicroscopy in diabetic maculopathy.

OBJECTIVES To estimate the agreement between the macular edema maps (MEMs) of the Retina Module of the Heidelberg Retina Tomograph II (Heidelberg Engineering, Heidelberg, Germany) and contact lens fundus biomicroscopy (FB) and to assess the influence of combining MEM data with the results of short-wavelength automated perimetry (SWAP) and fluorescein angiography (FA) on diagnostic test performance. DESIGN Prospective, observational case series. METHODS Twenty patients (20 eyes) with diabetic retinopathy with or without clinically manifest macular edema (11 and 9 eyes, respectively) were enrolled. All patients underwent full ophthalmologic examination and also MEM assessment, SWAP, and FA. RESULTS Using FB as the "gold standard," the agreement between the MEMs and FB was very good (Kendall coefficient of concordance, 0.80). Macular edema maps showed good agreement with FA and SWAP (Kendall coefficient, 0.64 and 0.65). Virtually all of the edematous areas detected with MEM but not seen clinically had decreased sensitivity on SWAP and/or fluorescein leakage. CONCLUSIONS Macular edema maps demonstrated very good agreement with FB. Combining the results of FA and SWAP with those of the MEMs provided supporting evidence of concomitant blood-retinal barrier leakage and visual dysfunction, respectively, in areas of early retinal thickening. Prospective studies are ongoing to fully assess the diagnostic test performance of MEMs in the detection of early and progressive diabetic macular edema.