The New Hoya Vivinex Gemetric Trifocal Iol. Interim Results From An International Registry

To report the early results of a new to be launched in 2022 diffractive trifocal IOL, the Vivinex Gemetric, (HOYA Surgical Optics, Singapore), both non-toric and toric versions. The IOLs were implanted to replace the lens during cataract surgery. “Real world” data was collected by an international registry during the pre-commercial launch phase.

Carones Vision @ Advalia, Milan, Italy, and multiple other anonymous locations.

Preoperative and postoperative data were uploaded by the study participants using the CLEARlog software. Parameters evaluated were distance corrected visual acuity (CDVA) uncorrected distance visual acuity (UDVA), uncorrected intermediate visual acuity (UIVA), uncorrected near visual acuity (UNVA), manifest residual sphere (MRS), manifest residual cylinder (MRC), spectacles usage at different distances, photic phenomena, and patient satisfaction. All visual acuity measurements were reported using LogMAR scale. In order to exclude as many non-lens related variables as possible, this analysis includes only eyes which achieved postoperative CDVA better than 0.0 LogMAR (best cases), and with a follow-up period of up to 6 months.

Interim results for the non-toric version, 57 eyes were analyzed. 87.7% of them had UDVA ≤ 0.1, 79.1% of eyes had UIVA ≤ 0.2, and 87.7% of eyes had UNVA ≤ 0.2. 90.9% of eyes were within ± 0.50 D MRS and 30.9% had MRC ≥ 0.75 D. For the toric IOL version, 17 eyes were analyzed. All eyes had UDVA ≤ 0.1, 66.7% of eyes had UIVA ≤ 0.2, and 82.4% of eyes had UNVA ≤ 0.2. 75% of eyes were within ± 0.50 D MRS, and 18.8% had MRC ≥ 0.75 D. In general, 91.4%, 94.7% and 89.5% of patients never use spectacles for distance, intermediate and near respectively. Photic phenomena were not severe in 93.8% (halos), 97% (glare) and 98.5% of cases. Satisfaction rates scored higher than 96.6%, and 98.1% would recommend this procedure.

The Vivinex Gemetric trifocal IOL provided high levels of spectacles independence with acceptable photic phenomena, leading to a high level of patient satisfaction. It is well established with other diffractive IOLs that performance is sensitive to residual refractive error, and in particular residual astigmatism. As expected, the data demonstrates that this is the case for the Vivinex Gemetric as well. The recommendation when using diffractive trifocal IOLs is to target emmetropia, and to always correct preexisting astigmatism using the toric version when available. Patients with astigmatism that cannot be corrected with a high degree of confidence should be identified preoperatively and offered alternative treatments.