Stability and Clinical Outcomes of A New One Piece Toric Intraocular Lens with Anchor-wing Haptics
Abstract Background: To evaluate the safety and efficacy of a new toric intraocular lens (IOL) with anchor-wing haptics.Methods: The new toric IOL with anchor-wing haptics (NS60YT, NIDEK Co., Ltd.) was implanted in eligible patients with age-related cataracts with preoperative corneal astigmatism of 1.0 D or greater at one university hospital and two private hospitals in Japan. Four cylinder powers of the IOL were evaluated as follows: 1.50 D (NS60YT3), 2.25 D (NS60YT4), 3.00 D (NS60YT5) and 4.50 D (NS60YT7). All patients were assessed out to 12 months postoperatively. The primary endpoint was uncorrected visual acuity (UCVA) with spherical addition 6 months postoperatively, and the primary analysis calculated the proportion of UCVA with spherical addition of 0.8 or better. The magnitude of rotation was compared to the intended axis of IOL implantation at each postoperative examination. Adverse events were evaluated for the safety analysis. Results: The study enrolled 64 eyes of 53 patients. At 6 months postoperatively, for all models, mean UCVA with spherical addition of 0.8 or better was achieved in 90% [95% confidence interval (CI): 80-96] of eyes. The mean IOL rotation was 5.3±4.3° 12 months after surgery. Between each postoperative examination from 1 day to 12 months, the mean magnitude of rotation ranged between 1.9° to 2.5°.There were no vision threatening intraoperative or postoperative complications for the duration of the study.Conclusions: The NS60YT IOL remained stable after implantation and was efficacious for treating 1.00 D or greater astigmatism in patients with senile cataracts.Trial registration: This study was registered at ClinicalTrials.gov (NCT03242486) on August 8, 2017 - Retrospectively registered. (https://clinicaltrials.gov/ct2/show/NCT03242486)