Abstract
PURPOSE: This study aimed to evaluate and compare the clinical outcomes obtained after cataract surgery with an aspheric monofocal intraocular lens (IOL) and an enhanced IOL with a modified optical profile. METHODS: Randomised clinical trial enrolling 70 patients (age, 52-87 years) undergoing cataract surgery. Two groups were created according to the type of IOL implanted: Vivinex iSert from Hoya Surgical Optics (Vivinex group, 35 patients) and Tecnis Eyhance ICB00 from Johnson & Johnson Vision (Eyhance group, 35 patients). Uncorrected (UDVA) and corrected distance visual acuity (CDVA), uncorrected (UIVA) and distance-corrected intermediate visual acuity (DCIVA), refraction, and self-perceived visual function (Catquest-9SF) were evaluated during a 3-month follow-up. RESULTS: No significant differences were found between IOL groups in UDVA and CDVA (p ≥ 0.093). In contrast, monocular and binocular UIVA and DCIVA were significantly better in the Eyhance group at 1 (p ≤ 0.015) and 3 months postoperatively (p ≤ 0.002). Postoperative DCIVA 20/25 or better was obtained in 71.4% and 20.0% of patients in Eyhance and Vivinex groups, respectively. Differences in postoperative Rasch calibrated Catquest scores between Eyhance and Vivinex groups did not reach statistical significance (p ≥ 0.102). However, significant correlations were only found between the change in UIVA and Catquest scores (0.364 ≤ r ≤ 0.444, p ≤ 0.041) in the Eyhance group. CONCLUSIONS: The modified monofocal IOL evaluated provides better intermediate visual function in comparison with a standard aspheric monofocal IOL, but the impact of this benefit on the self-perceived level of vision achieved after surgery according to the patient seemed to be limited.