Abstract
INTRODUCTION: To evaluate the short-term safety and efficacy of the EVO implantable collamer lens (ICL) using a customized implanting orientation design based on ultrasound biomicroscope (UBM) measurement. METHODS: The prospective case series included 310 eyes of 158 patients treated with ICL. To achieve an optimal vault, an ICL of specific size was chosen and implanted in a customized orientation according to assessment of sulcus-to-sulcus (STS) diameters, distance between STS plane and crystalline lens (STSL), the morphology of ciliary sulcus (MCS), anterior chamber depth (ACD), and white-to-white (WTW). With the new design, there were 138 eyes with a non-horizontal orientation and 172 eyes with a horizontal orientation of the ICL. Refractive and ICL vault statuses were followed up for 1 day and 1 month postoperatively. RESULTS: The safety index at 1 month was 1.34 ± 0.17 for the non-horizontally implanted group and 1.33 ± 0.16 for the horizontally implanted group; the efficacy index was 1.21 ± 0.18 for the non-horizontally implanted group and 1.18 ± 0.16 for the horizontally implanted group. All eyes achieved an uncorrected distance visual acuity of 0.10 logMAR or better. No significant difference in endothelial cell density was observed between the preoperative value (2792.6 ± 247.6 cells/mm(2)) and value at 1 month postoperatively (2744.2 ± 243.3 cells/mm(2)), and no cataract or anterior subcapsular opacification was observed. Ideal vault (250-750 μm) was achieved in 84% of eyes (260/310). CONCLUSION: The customized ICL design of implanting orientation based on UBM measurement provides good safety, efficacy, and vault predictability.