Clinical Performance After Implantation of a New Purely Refractive Extended Depth of Field Intraocular Lens in Cataract Patients

Purpose: To evaluate the functional outcomes including visual performance and patient reported outcomes after implantation of a refractive Extended Depth of Field (EDoF) intraocular lens (IOL) in a post-approval prospective, non-controlled study. Patients and Methods: Fifty-eight eyes of 29 patients (mean age: 71 ± 11 years) that underwent phacoemulsification cataract surgery with implantation of a DEN00V or DET100-600 IOL (TECNIS PureSee, Johnson & Johnson Vision Inc. Jacksonville, Florida, USA) were included in this prospective study. Postoperative follow-up at 3 months included uncorrected and corrected distance visual acuity (UDVA/CDVA), uncorrected and distance corrected intermediate visual acuity at 80 cm (UIVA/DCIVA), and uncorrected and distance corrected near visual acuity at 40 cm (UNVA/ DCNVA), as well as binocular corrected defocus curve analysis (range +2 to − 4 dioptres), contrast sensitivity under photopic and mesopic conditions (CSV-1000, VectorVision, Greenville, USA) and patient-reported outcome (Heidelberg Daily Task Evaluation (DATE) Questionnaire and halo and glare evaluation). Results: Mean binocular visual acuity in logMAR at 3 months was UDVA/ CDVA (− 0.02/ − 0.07), UIVA/ DCIVA (0.03/ 0.02) and UNVA/ DCNVA (0.16/ 0.16). The defocus curve analysis showed a visual acuity of 0.20 logMAR or better up to − 2.25 D. Contrast sensitivity under photopic and mesopic conditions was within normal age limits. The study IOL was non-inferior to standard monofocal lenses in terms of halo/glare. Eighty-three percent of participants were fully satisfied with the outcome of the IOL implantation and ninty-six percent of patients would repeat the surgery with the same IOL and recommend the IOL to friends or acquaintances. Conclusion: The TECNIS PureSee IOL yielded good visual performance with high patient satisfaction. Patients received a good EDoF-effect with a low probability of disturbing photopic phenomena in terms of halo and glare.