Customizing Clinical Outcomes with Implantation of Two Diffractive Trifocal IOLs of Identical Design but Differing Light Distributions to the Far, Intermediate and Near Foci.

Abstract

To evaluate clinical outcomes after bilateral or contralateral implantation of the Gemetric™ (G) and Gemetric™ Plus (GPlus) diffractive trifocal intraocular lenses (IOLs). This was a prospective, randomized, multi-center open-label study comparing clinical results and subjective patient responses around 6 months after implantation of the study lenses (toric and non-toric) in three different groups (bilateral G, bilateral GPlus and contralateral G/GPlus implantation). Results included the manifest refraction, uncorrected and distance corrected monocular and binocular visual acuity (VA) at distance, intermediate and near; the defocus curve; contrast sensitivity; and patient reported outcomes regarding spectacle independence, satisfaction and visual disturbances. There was no statistically significant difference in the mean refraction spherical equivalent between the two lens models (p = 0.33) or between the toric and non-toric lenses (p = 0.06). Monocular VA was better at distance with the G lens and better at near with the GPlus lens (p < 0.01). Mean binocular VA was better than 0.1 logMAR at all distances for all groups, both uncorrected and distance corrected. The mean binocular distance corrected VA was better than 0.15 logMAR from 0.0 D to -3.50 D for all groups. All VA data for the contralateral group was as good or better than for the bilateral GPlus group. Questionnaire results showed no difference between groups for the frequency, severity, or degree of bother of visual disturbances (p > 0.24). The two diffractive trifocal IOLs studied here may be used either bilaterally or contralaterally for the correction of presbyopia in cataract patients, providing excellent visual acuity with low levels of visual disturbances and high rates of overall spectacle independence. Bilateral Gemetric implantation resulted in slightly better distance and intermediate vision while contralateral implantation provided slightly better near vision. There was no apparent advantage to implanting the GPlus IOL bilaterally.