Long-term Prevalence of Opacification of a Hydrophylic Acrylic Rotationally Asymmetric Refractive Multifocal Intraocular Lens.

PURPOSE: To determine the prevalence of opacification of a hydrophylic intraocular lens (IOL) with hydrophobic coverage and the percentage of explantations required, determining possible risk factors associated with these opacifications.

METHODS

This ambispective study enrolled 575 eyes of 296 patients (age 36 to 87 years) that underwent cataract surgery between 2010 and 2017 with implantation of different models of Lentis Mplus IOLs: LS-312-MF30, LS-313-MF15, LS-313-MF30, LU-313-MF30, and LU-313-MF30T (Oculentis GmbH). Visual, refractive, and slit-lamp biomicroscopic changes were evaluated in a long-term follow-up. The percentage of cases with IOL opacification and the percentage of cases in which IOL explantation was required due to such opacifications were calculated at each visit. Five of the explanted IOLs from this series could be analyzed by scanning electron microscopy (SEM-EDX).

RESULTS

IOL opacification developed in 63 eyes (11.0%). With 95% confidence, the prevalence of IOL opacification was between 842 and 1,401 cases per 10,000 eyes. The time elapsed between surgery and the presence of IOL opacification ranged between 0 and 9.3 years (mean: 4.7 ± 2.2 years). No significant differences in terms of IOL opacification rate were found according to gender (P = .378). No significant differences were found in arterial hypertension, diabetes, hypothyroidism, or hyperthyroidism rates between eyes with or without IOL opacification (P ≥ .053). IOL explantation was needed in 9 eyes (1.57%). SEM-EDX analysis confirmed the presence of rough areas on the IOL surface containing different components, such as calcium, phosphorous, copper, or nitrogen.

CONCLUSIONS

The prevalence of opacification with time in Lentis Mplus IOLs is high, with no systemic risk factors associated with this complication, suggesting that it may be attributable to the material and/or the manufacturing process. [J Refract Surg. 2024;40(2):e98-e107.].