Results of a clinical evaluation of a trifocal intraocular lens in Japan.

Purpose: To evaluate the effectiveness and safety of a new trifocal intraocular lens (IOL) after cataract removal in patients living in Japan.

Study Design: Prospective multicenter clinical study.

Methods: One hundred and thirty-five eyes of 68 patients (19 men, 49 women; mean age, 66.3 ± 7.4 years) were followed for 6 months. Trifocal IOLs with focal points at near, intermediate, and distance were implanted bilaterally in eyes with less than 1 diopter of corneal astigmatism. The visual acuity (VA) at distance, 60 and 40 centimeters (cm), and contrast sensitivities were measured. Patients completed quality-of-life questionnaires preoperatively and postoperatively.

Results: The mean bilateral logarithm of the minimum angle of resolution VA at 5 meters (m), 60 cm, and 40 cm were, respectively: uncorrected, - 0.104 ± 0.095, - 0.065 ± 0.111, and - 0.042 ± 0.105; and distance-corrected, - 0.197 ± 0.076, - 0.112 ± 0.111, and - 0.073 ± 0.111. The contrast sensitivities at distance and near were within the normal range at all spatial frequencies under photopic conditions. Patients reported complete spectacle independence in 75.0% of cases. Total use of spectacles was reported by 1.5% and partial by 20.6%; the purpose of spectacle use was primarily for near visual tasks. Mild-to-moderate glare was reported by 65.7% of patients and halos by 70.1%; only 1.5% of subjects reported severe glare and halos.

Conclusions: This new trifocal IOL provides equally good uncorrected VAs at distance, intermediate, and near, and decreases spectacle dependence in daily life. Patients frequently report mild-to-moderate glare and halos, and patients should be informed about these before implantation.