Efficacy, Safety, And Satisfaction In Patients With A 5-Foci Pseudophakic Lens, Two Years After Surgery

To evaluate the safety, visual performance, and patient satisfaction of a new presbyopic pseudophakic intraocular lens (IOL), two years after surgery.

Clínica de Ojos Dr. Nano, Olivos (Buenos Aires), Argentina.

An ambispective single-arm, single-center, study, was performed, including patients bilaterally implanted with a 5-foci pseudophakic IOL (Intensity SL, Hanita Lenses), who underwent femtosecond laser-assisted cataract surgery (FLACS) between October 2020 and September 2021, with follow-up visits of two years after the second eye surgery. Uncorrected distance, intermediate, and near visual acuity (UDVA/UIVA/UNVA), and defocus curve, as well as safety parameters (endothelial cell density (ECD), central corneal thickness (CCT), and intraocular pressure (IOP), and patient satisfaction (VF-14 QOL questionnaire) were evaluated. Posterior capsular opacifications (PCO), ocular surface, and macular thickness were also evaluated.

A total of 120 eyes of 60 patients aged 68.32 ±8.9 years were included. The mean UDVA was 0.01 ±0.07 logMAR. For 80 cm: 0.07 ±0.07; for 66 cm: 0.05 ±0.07; for 40 cm: 0.09 ±0.08. The mean binocular UDVA was -0.05 ±0.05 logMAR. Posterior capsular opacifications were not observed. Two patients (4 eyes) developed postoperatively a mild dry eye symptom. When examining the fundus, no relevant condition was detected in the patient group during follow-up, no patient developed retinal detachment. The retinal OCT showed normal macular thickness in all eyes after surgery. ECD, CCT, and IOP remained stable (without statistical significance differences). The mean score value of the VF-14 QOL questionnaire 21 to 24 months postoperatively was 98.6.

The present study has shown that the far, intermediate, and near vision obtained by the patients operated with a 5-foci presbyopic pseudophakic IOL allows most of them not to use spectacles, reporting a high level of satisfaction, without having detected relevant complications, two years after surgery.