Clinical Evaluation Of A Rotationally Symmetric Fully Refractive, Multifocal, And Multifocal-Toric Intraocular Lens - Interim Analysis.

Cataract surgery is the most frequently performed surgery in Germany. In this context, patient needs and expectations increasingly aim at spectacle independence. The aim of this study was to evaluate the clinical outcome after implantation of a rotationally symmetric fully refractive, multifocal (toric) intraocular lens (IOL) in eyes after cataract surgery.

In this prospective monocentric interventional study 50 eyes of 25 patients will be included. So far, 28 eyes of 15 patients underwent surgery and were evaluated in this interim analysis. 

The mean patient age was 68.50 ± 6.65 years. Mean axial length was 23.91 ± 1.16 mm with a mean corneal astigmatism of 1.10 ± 0.46 D (diopter). All patients' eyes showed no visual impairing ocular pathology other than cataract. 

Surgical treatment was performed with a PRECIZON Presbyopic NVA or NVA Toric intraocular lens under local anesthesia. Postoperative follow-ups were performed 1 day, 1 week and 3 months after surgery. The (un)corrected near, intermediate and distance visual acuity defocus curves (3 months postoperative) were performed. Regarding the evaluation of the rotational stability, photo documentation of the IOL in mydriasis was performed.

There was an improvement of uncorrected distance visual acuity from 0.66 ± 0.36 logMAR to -0.02 ± 0.08 logMAR (3 months postoperative, n= 12, p < 0.05). Uncorrected near visual acuity reached 0.17 ± 0.26 logMAR (3 months postoperative, n = 12). The mean uncorrected intermediate visual acuity was 0.23 ± 0.23 logMAR. Mean refractive astigmatism reduced from -1.10 ± 0.46 D to -0.53 ± 0.39 D (3 months postoperatively). Mean postoperative IOL rotation was 1.64° (1 day postop, median 0°) and 2.05° (1 week postop, median 1°) and 3.50° (3 months postop, median 3°). Subjective complaints, such as disturbing photic phenomena such as glare sensitivity or halos, were not described.

To date, the Ophtec PRECIZON Presbyopic IOL shows promise as an option for achieving spectacle independence after cataract surgery. Common photic phenomena have not been reported so far, for further evaluation the finalization of this study remains pending.