A One‐Year Visual and Safety Evaluation of a Newly Available Trifocal Intraocular Lens in Patients With Bilateral Cataracts: Clinical Outcomes From a Prospective Study
Abstract
Purpose To evaluate the effectiveness and safety of a new trifocal intraocular lens (IOL) in patients with age‐related cataracts 12 months after surgery. Methods This prospective, noncomparative, multicenter study included 122 patients (244 eyes) undergoing cataract surgery with bilateral implantation of the AT ELANA 841P. At 12 months postoperatively, refraction and binocular visual acuity (VA) at distance (4 m), intermediate (80 cm), and near (40 cm) were measured. Visual symptoms and spectacle independence were subjectively evaluated. Safety assessment included the rate of ocular adverse events (AEs), posterior capsule opacification (PCO), IOL tilt and decentration, and glistening formation. Results At 12 months postoperatively, most eyes (90.6%) were within ± 0.5 D spherical equivalent (SE) refraction, and almost all (99.6%) were within ± 1.0 D. Overall, 100% of patients achieved binocular uncorrected VA of 0.2 logMAR or better at distance. Performance at intermediate and near was 98.4% and 88.5%, respectively. All patients were spectacle‐free at far and intermediate distances (100%), and 88.5% were spectacle‐free for near tasks; over 80% reported no visual symptoms. The eye‐related AE rate was low, with mild‐to‐moderate intensity. Up to 12 months, 91.7% of the eyes had no PCO, while 3.2% were treated with posterior capsulotomy. IOL tilt was not observed; only a small number of decentration cases were monitored, and these were clinically insignificant (< 1 mm) at the final visit. At 12 months, the IOL showed no glistening (97.5%) or traces only. Conclusion Implantation of the AT ELANA 841P provided reliable refractive and visual outcomes, high rates of spectacle independence, and corrected and uncorrected VA at all distances. The IOL exhibited a favorable safety profile over 12 months, characterized by minimal visual symptoms, low PCO, no glistening (or only trace), and a stable position in the eye. Trial Registration: ClinicalTrials.gov identifier: NCT06247683