To investigate the advantages, clinical outcomes, and safety after implantation of the 1CU (HumanOptics AG) optic shift intraocular lens (IOL) in comparison with a conventional monofocal IOL.METHODS
In a prospective non-randomized study, 553 eyes implanted with the 1CU IOL were examined. In a control group, a monofocal posterior chamber IOL (MCTE, Dr Schmidt) was implanted in 219 eyes. Follow-up was performed at 1, 6, and 12 months postoperatively. The clinical effect for near visual acuity was evaluated by subjective measurements using an accommodometer, defocusing curve, and Nieden charts.RESULTS
No significant differences were noted in distance best spectacle-corrected visual acuity (BSCVA) between groups. Average near visual acuity with distance BSCVA for the 1CU was 0.41 and 0.35 for the control group. The difference in the accommodation response between both groups measured with the accommodometer was 11 cm (P<.01). The refraction tolerance for the 1CU was 0.25 D whereas the MCTE revealed no refraction tolerance (P<.01). Decentration and tilting of the 1CU resulted in explantation of three IOLs.CONCLUSIONS
The 1CU indicates a minor statistical advantage of half a reading step towards monofocal IOLs measured with subjective methods in near point, defocusing curve, and near visual acuity with distance BSCVA. This could be due to pseudophakic accommodation by the optic shift mechanism or a result of additional pseudophakic pseudoaccommodation. The accommodative effect of the 1CU differed from patient to patient and was not predictable.