Efficacy, safety, and satisfaction in patients with a functional 5-focus pseudophakic lens 2 years after surgery.

Abstract

Purpose: To evaluate the safety, visual performance, and patient satisfaction of a new presbyopic pseudophakic intraocular lens (IOL).

Methods: An ambispective non-randomized study was performed in Buenos Aires, Argentina. Patients included in the study underwent a programmed femtosecond laser-assisted cataract surgery (FLACS), performed between October 2020 and September 2021, with a 24-month follow-up period. The Intensity SL (Hanita Lenses) IOL was bilaterally implanted. Uncorrected distance, intermediate, and near visual acuity (UDVA/UIVA/UNVA, respectively), and defocus curve as well as safety parameters were measured, and patient satisfaction was evaluated with the VF-14 QOL questionnaire.

Results: A total of 120 eyes of 60 patients (34 women and 26 men) aged 68.32 ± 8.9 years (54-85) were included. At the last follow-up, the mean monocular UDVA in eyes (n = 120) with an Intensity SL IOL implanted was 0.01 ± 0.07 logMAR, and the corrected distance visual acuity (CDVA) was -0.05 ± 0.06 logMAR. For 120 cm, mean UIVA was 0.06 ± 0.11 logMAR; for 80 cm, mean UIVA was 0.07 ± 0.07 logMAR; for 66 cm, mean UIVA was 0.05 ± 0.07 logMAR and for 40 cm, mean UNVA was 0.09 ± 0.08 logMAR (-0.1 to 0.2). The mean binocular UDVA in our patient group was -0.05 ± 0.05 logMAR. Glare and halo were rare phenomena. Patient satisfaction was high. The mean score value of the VF-14 QOL questionnaire 24 months postoperatively was 98.6.

Conclusion: Patients underwent safe bilateral implantation with Intensity SL IOL, achieving spectacle independence in most cases, and reported a high degree of satisfaction, refraction, and vision stability 24 months after surgery.