Purpose: To evaluate the effectiveness and safety of 2 enhanced monofocal intraocular lenses (IOLs). The TECNIS Eyhance IOL (Model ICB00) was compared with a standard monofocal IOL (TECNIS Monofocal, Model ZCB00). Setting: European multicenter study. Design: Prospective, bilateral, randomized, comparative/evaluator-masked, controlled study. Methods: Adult subjects scheduled to undergo bilateral, primary phacoemulsification cataract extraction and posterior IOL implantation were randomized to receive the enhanced monofocal ICB00 IOL or the monofocal ZCB00 IOL in both eyes. Monocular endpoints at 6 months included distance-corrected intermediate visual acuity (DCIVA), photopic corrected distance visual acuity, and uncorrected intermediate visual acuity (UIVA). Binocular visual acuities, monocular corrected distance contrast sensitivity (first eyes), patient-reported outcomes, and safety were assessed at 6 months. Results: Overall, 139 patients were bilaterally implanted with the enhanced monofocal IOL (n = 67) or standard monofocal IOL (n = 72) and available for the 6-month visit. The enhanced monofocal IOL significantly improved mean monocular and binocular DCIVA and UIVA by at least 1-line logarithm of the minimum angle of resolution vs the standard monofocal IOL (all P ≤ .0001). Distance vision for the enhanced monofocal IOL was 20/20 or better and comparable with that of the standard monofocal lens at 6 months. Contrast sensitivity, photic phenomena outcomes, and rates of adverse events were similar between the 2 groups. Conclusions: In patients undergoing cataract surgery, TECNIS Eyhance IOL Model ICB00 provided enhanced intermediate vision and similar distance performance and photic phenomena compared with a standard monofocal IOL, along with improved functional performance in daily life.

Purpose: To evaluate the postoperative rotational stability of two prototype intraocular lens (IOL) designs (subsequently termed version 1 and version 2). Patients and Methods: A prospective, multicenter, randomized, paired-eye, 6-month study evaluated the version 1 and version 2 IOLs. Results were compared with a control IOL (TECNIS ® toric 1-piece monofocal IOL) evaluated in a separate, similarly designed study. Participants aged ≥22 years and scheduled to undergo bilateral cataract extraction were randomly assigned 1:1 to receive the version 1 or version 2 IOL in the first operative eye; the alternate test IOL was then implanted in the second operative eye. Results: Mean absolute IOL rotation at postoperative week 1 was the primary effectiveness end point. Additional end points included the percentage of eyes with postoperative IOL rotation >5°/>10°, direction of lens rotation, surgeon-reported ease of IOL handling during implantation, and safety. At postoperative week 1, mean (±standard deviation) absolute IOL rotation was significantly lower for both version 1 and version 2 versus control (0.88° [±0.94] and 0.71° [±0.69] vs 2.24° [±3.21], respectively; both P < 0.001). For both study lenses, absolute rotation was <5° for all eyes at postoperative week 1, and no cases of rotation >10° were observed at any postoperative time point. From postoperative week 1 onward, version 2 had a statistically significant clockwise bias in the direction of rotation (P = 0.03); similar findings were observed for version 1. Surgeons reported acceptable ease of IOL handling during implantation for both version 1 and version 2. No device-related adverse events were reported. Conclusion: Both the version 1 and version 2 IOLs, each with frosted, squared haptics, demonstrated improved postoperative rotational stability compared with a control lens without frosted haptics. Because version 2 had the same overall geometry as the current TECNIS toric IOL, this design was selected for commercialization. Trial Registration: German Clinical Trials Register, DRKS00015287.

Randomized comparison of the TECNIS Symfony (ZXR00) and the TECNIS 1-piece monofocal (ZCB00) intraocular lenses in cataract surgery demonstrates improved intermediate and near vision with TECNIS Symfony.