Clinical Outcomes After Bilateral Simultaneous Implantation Of Two Diffractive Trifocal Intraocular Lenses With Different Light Distribution Profiles

To evaluate the efficacy and safety after bilateral same day implantation of the toric and non-toric Vivinex Gemetric and Vivinex Gemetric Plus IOLs (Hoya Surgical Optics) in patients without cataract. This concept is called “pairing approach” as both models have the same IOL design and add power but different light distribution profiles.

This prospective, single-center, open-label, bilateral, single arm clinical study is conducted at the Medipolis Private Clinic in Antwerp, Belgium

In this study, 60 eyes of 30 patients will undergo bilateral simultaneous lens extraction with the implantation of Vivinex Gemetric/Gemetric Plus IOLs by using the pairing approach. The postoperative follow-up at 3 months includes monocular and binocular uncorrected (UDVA) and corrected (CDVA) distance visual acuity, uncorrected (UIVA) and distance corrected (DCIVA) intermediate visual acuity at 66 cm, and uncorrected (UNVA) and distance corrected (DCNVA) near visual acuity at 35 cm. A subjective patient questionnaire will be part of the 3-month follow-up visit.

Results from the 3-month follow-up of monocular and binocular uncorrected and distance-corrected visual acuity and subjective patient satisfaction will be presented at the ESCRS Congress in Copenhagen.

All 30 patients have been recruited for the study and the follow-ups are ongoing. It is expected that all results should be available by the time of ESCRS. Based on experience from the clinical use of these trifocal lenses, we expect excellent visual acuity outcomes and a high rate of spectacle independence at far, intermediate, and near distance as well as satisfied patients.