Clinical safety and efficacy of a hydrophilic acrylic intraocular lens in a real-world population: a 1-year follow-up retro-prospective study

BACKGROUND: This multicentre, retro-prospective real-world study evaluated the visual, refractive and safety outcomes of a monofocal lens 1 year after implantation in cataract patients with or without pre-existing ocular pathologies. METHODS: Records from 4 centres in Germany and Sweden were reviewed to select eyes with aged-related cataracts, having undergone crystalline lens extraction by phacoemulsification and implantation of a CT ASPHINA 409 IOL. Preoperative, 1-month and 3-month postoperative data was collected retrospectively. In addition, included patients attended a prospective visit 12 months or later after surgery. The examination included: monocular uncorrected (UDVA) and corrected distance visual acuity (CDVA), subjective refraction, slit-lamp examination, optical biometry, intraocular pressure (IOP), endothelial cell count and postoperative complications. RESULTS: 282 eyes, including 94 with pre-existing ocular pathologies, were analysed. Twelve months after the surgery, 95% of eyes achieved monocular CDVA equal or better than 0.3 logMAR, mean postoperative CDVA was 0.06 ± 0.17 logMAR, and mean UDVA 0.31 ± 0.29 logMAR. Visual acuity outcomes were better in eyes with no pre-existing ocular pathologies, but both groups showed a statistically significant improvement after surgery compared with preoperative values (p ≤ 0.002). The mean sphere and spherical equivalent values also improved significantly postoperatively (p = 0.003). Overall, 62.1% of eyes had spherical equivalent within ±0.5 D and 80.9% within ±1.0 D. The IOL was stable in the capsular bag as demonstrated by tilt and decentration measurements. IOP, corneal status, and endothelial cell count values were in the normal range. Nd:YAG treatment was performed on 9.9% of the eyes. CONCLUSION: The implantation of the monofocal CT ASPHINA 409 IOL was beneficial to restore vision in eyes with or without concomitant ocular pathology such as macular degeneration, glaucoma, Sicca syndrome, epiretinal membrane, cornea guttata, or amblyopia. Good to excellent long-term visual and refractive outcomes, and a low rate of complications in both healthy and pathological eyes were found 12 months after the surgery. TRIAL REGISTRATION: Trial registered on under the identification NCT03145103 (date of registration 9 May 2017).