12-Month Visual and Clinical Outcomes After Implantation of a Monofocal Aspheric Hydrophobic Acrylic IOL: A Prospective Feasibility Study.

PURPOSE: To evaluate 12-month visual and clinical outcomes after implantation of a monofocal aspheric hydrophobic acrylic intraocular lens (IOL) delivered with a preloaded system. METHODS: This investigator-initiated, prospective, single-center, uncontrolled feasibility study enrolled 30 patients undergoing unilateral or bilateral cataract surgery with implantation of the OPTIFLEX GENESIS COMFORT NY IOL. Twenty patients contributed 22 operative eyes to the per-treatment evaluable analysis at 12 months. Uncorrected distance visual acuity (UDVA), corrected distance visual acuity (CDVA), manifest refraction, contrast sensitivity, and intraocular pressure (IOP) were assessed postoperatively. Posterior capsule opacification (PCO), clinically detectable IOL tilt, decentration, discoloration, and higher-order aberrations were evaluated during follow-up. RESULTS: Mean preoperative UDVA and CDVA were 0.64 ± 0.33 and 0.30 ± 0.23 logMAR, respectively. Mean UDVA improved to 0.12 ± 0.16 logMAR at 3 months and 0.19 ± 0.16 logMAR at 12 months. Mean CDVA improved to -0.01 ± 0.10 logMAR at 3 months and 0.01 ± 0.09 logMAR at 12 months. IOP remained stable, and no statistically significant change in spherical equivalent refraction was observed, although a numerical hyperopic trend was noted. At 12 months, PCO was absent in 15 eyes and minimal in 7 eyes. No clinically detectable IOL tilt, decentration, or discoloration was recorded. Contrast sensitivity was generally within or close to age-matched reference ranges. CONCLUSION: In this uncontrolled prospective feasibility cohort, implantation of the investigated monofocal aspheric hydrophobic acrylic IOL was associated with improved distance visual acuity and stable IOP through 12 months. The findings provide preliminary device-specific clinical data and should be confirmed in larger controlled studies with longer follow-up.