Tomographic changes after implantation of a refractive corneal inlay in presbyopic patients

Purpose To determine the tomographic changes of the cornea over a 12-months period following the implantation of a refractive corneal inlay. Methods This prospective, non-randomized clinical study was conducted at the Department of Ophthalmology, Goethe University, Frankfurt, Germany. The patients received a refractive corneal inlay (Flexivue Microlens, Presbia, CA, USA) in the non-dominant eye. Scheimpflug tomography for assessing simulated keratometry (simK), total corneal refractive power (TCRP), changes in higher-order aberrations (HOA), changes in optical densitometry (COD) and subjective refraction were measured one day, one week, one month, three, six, and twelve months postoperatively. Vector analysis was performed with the rectangular vectors J0 and J45 for detecting changes in corneal astigmatism and analyzing corneal surgical induced astigmatism (C-SIA). Results SimK of the steep meridian (K2) was 43.17 ± 1.65 diopter (D) preoperative and 43.51 ± 1.70 D at the twelve-month visit (p = 0.003). SimK astigmatism values changed from 0.78 ± 0.38 D to 1.22 ± 0.53 D (p = 0.003). TCRP astigmatism values were 0.64 ± 0.39 D preoperative and 1.07 ± 0.45 D twelve months postoperative (p = 0.001), mean keratometry (K _m ) was 42.12 ± 1.59 D preoperative and changed to 42.49 ± 1.62 D (p = 0.007), respectively. The C-SIA was 0.57 D at 98.8° 12 months postoperative. Conclusion There was significant steepening in simK and TCRP twelve months after implantation of a refractive corneal inlay.