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

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.

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).

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.

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.