One year results of European Multicenter Study of intrastromal corneal ring segments. Part 1: refractive outcomes

PURPOSE: To assess the efficacy, predictability, stability, and safety of correcting myopia with intrastromal corneal ring segments (ICRS, KeraVision, Inc.). SETTING: Twelve European investigational sites. METHODS: Patients with myopia of -1.0 to -6.0 diopters (D) and best spectacle-corrected visual acuity (BSCVA) of 20/20 or better (except in 3 eyes) were assigned to receive 1 of 5 ICRS thicknesses (0.25, 0.30, 0.35, 0.40, or 0.45 mm). Efficacy was assessed by postoperative uncorrected visual acuity (UCVA), predictability of refractive outcome (deviation from predicted cycloplegic refraction spherical equivalent), and stability of refractive effect (manifest refraction spherical equivalent MRSE]). Safety was assessed by maintenance or loss of preoperative BSCVA and induced manifest refraction cylinder. Measurements were made preoperatively and 1 and 7 days and 1, 2, 3, 6, and 12 months postoperatively. RESULTS: One hundred fifty-nine ICRSs were implanted in the eyes of 107 patients (52 patients had bilateral implantation). Preoperatively, UCVA was worse than 20/40 in 98% of eyes (155/159); 12 months postoperatively, it was 20/20 or better in 63% of eyes (83/132) and 20/40 or better in 96% (127/132). Predicted refractive corrections for each ICRS thickness generally correlated with achieved corrections. At 12 months postoperatively, 90% of eyes (124/138) were within +/-1.00 D of plano (MRSE). Two or more lines of BSCVA were lost in 6% of eyes (8/135); all 8 eyes had BSCVAs of 20/25 or better. CONCLUSION: The ICRS safely, effectively, and predictably reduced or eliminated low to moderate myopia. Refractive correction was stable through the 12 month follow-up.