Outcomes of a multicenter U.S. clinical trial of a new monofocal single-piece hydrophobic acrylic IOL

Abstract

Purpose: To evaluate the safety and effectiveness of the CT LUCIA 611P intraocular lens (IOL) in patients with cataracts. Setting: 23 surgeons at 15 different clinical sites. Design: Prospective single-arm clinical trial. Methods: The study was conducted under an Investigational Device Exemption for premarket approval of a new hydrophobic acrylic IOL in the United States. Patients were followed for 12 months, and the main measured variables included uncorrected (UDVA) and corrected (CDVA) distance visual acuities, manifest refraction, and adverse events. Results: In total, 339 eyes of 339 patients were implanted with the study device, of which 310 (91.4%) reached the 12-month visit. The percentage of eyes within ±0.50 diopter (D) and ±1.00 D of emmetropia was 85.8% (266/310) and 96.8% (300/310), respectively. Manifest refraction spherical equivalent (MRSE) remained stable over the first year with the mean 12-month MRSE of -0.03 ± 0.45 D. The mean 12-month UDVA and CDVA were 0.09 ± 0.15 (≈20/25) and -0.02 ± 0.09 (≈20/19) logMAR, respectively. Of all patients, 99.4% (308/310) achieved postoperative CDVA ≥20/40. The incidence of Nd: YAG capsulotomy within the first year was 3.5% (11/310). Only 2 eyes had IOL tilt present at the 12-month postoperative visit with no associated visual symptoms. There were 2 cases of IOL decentration; one required removal of the IOL, whereas the other had no visual side effects related to decentration. There were no findings of glistening at any visit. Conclusions: The CT LUCIA 611P IOL demonstrated excellent safety, efficacy, and stability of refractive outcomes. No significant issues related to the biocompatibility of the IOL material were observed.