Two-year corneal endothelial cell assessment following INTACS implantation.
PURPOSE: To evaluate the 2-year effects of intrastromal corneal ring segments (INTACS) on the corneal endothelium. METHODS: Non-contact specular microscopy was performed as a subgroup test in a Phase III clinical trial. Endothelial cell images were collected before surgery and at 6, 12, and 24 months after surgery at the central and peripheral (6 and 10 o'clock) regions. Images were recorded and analyzed later by a central reading center. Cell density, coefficient of variation, and percent hexagonal cells were determined. RESULTS: There were no clinically significant changes in the endothelial cell structure at 6, 12, and 24 months (102 eyes). There was a gain of 5 cells/mm2 (6 months) and 3 cells/mm2 (12 months) at the central region of the cornea and a loss of 28 cells/mm2 at 24 months. At the 6 o'clock region of the cornea, there was a loss of 0, 24, and 92 cells/mm2 at 6, 12, and 24 months. At the 10 o'clock region of the cornea, there was a loss of 14, 30, and 94 cells/mm2 at 6, 12, and 24 months. INTACS did not statistically affect the central cell density at 6 and 12 months, however, there was a slight loss centrally at 24 months. At 24 months, all corneal regions had a slight decrease in cell density. In all eyes, mean central and peripheral endothelial cell counts remained above 2495 cells/mm2. Coefficient of variation improved and percent hexagonal cells remained unchanged. CONCLUSION: Endothelial cell density changes at 2 years after INTACS implantation were not clinically significant and endothelial cell remodeling was present.