A prospective study of a new presbyopia pseudophakic intraocular lens: Safety, efficacy and satisfaction.

Abstract

To evaluate the safety, visual performance, and patient satisfaction of a new presbyopic pseudophakic intraocular lens (IOL). A prospective non-randomized case-series study was performed in Buenos Aires, Argentina. Patients included in the study underwent a programmed Femtosecond laser assisted cataract surgery (FLACS), performed between October and December 2020, with a 6-month follow-up period. The Intensity (Hanita Lenses) IOL was bilaterally implanted. Spherical equivalent (SE) refraction, uncorrected distance and near visual acuity (UDVA/UNVA), defocus curve, endothelial cell density (ECD), central corneal thickness (CCT), and a satisfaction questionnaire were evaluated. A total of 56 patients (112 eyes), aged 65 ± 6.12 years were included. The mean ± SD of preoperative SE was 1.85 ± 2.24 D (range; -4.50 to 4.75), which had decreased 6 months after surgery to -0.08 ±0.32 D (range; -0.75 to 0.63). No eyes experienced a loss of lines of vision, and 94% obtained SE values between ± 0.50 D. Defocus curve for different additions was 0.03 LogMAR (logarithm of the minimum angle of resolution) for -3.0 D, -0.005 LogMAR for -1.5 D, and -0.07 LogMAR for 0 D. The ECD, CCT remained stable (P: 0.09 and 0.58, respectively) and all patients achieved their preoperative expectations, with a 6-month follow-up period. Patients who underwent a safe bilateral implantation with Intensity IOL achieved a high degree of spectacle independence and satisfaction, 6 months after surgery.