In order to evaluate the clinical and confocal microscopic features of amiodarone keratopathy, we examined 12 eyes of six patients receiving amiodarone and 12 eyes of six healthy control subjects. The duration of amiodarone therapy ranged from 6 to 24 months (16 +/- 5.9 months). According to slit-lamp findings, seven eyes were graded as grade 1 and five as having grade 2 amiodarone keratopathy. In the basal cell layer there were highly reflective, bright, intracellular inclusions in the epithelial layer of all patients on amiodarone. In advanced cases, there were bright intracellular inclusions even in the endothelial cell layer, as well as the anterior and posterior stroma. The keratocyte density of the anterior stroma was reduced in cases with amiodarone keratopathy compared to the control group, and irregularity in stromal nerve fibers was significant in advanced cases (p < 0.001). Ultrasonic pachimetry showed a corneal thickness of 538 +/- 17.9 mum in the amiodarone group and 519 +/- 16.7 mum in the controls (ns). We suggest that in amiodarone-induced keratopathy, confocal microscopy is a useful, noninvasive technique for detecting deposits in the epithelial basal membrane early on, and which later appear in deeper layers.