Intermediate And Near Visual Outcomes In A Randomized, Comparative Study Of Two Commercially Available Trifocal Intraocular Lenses

To compare intermediate and near visual acuity outcomes of two commercially available trifocal intraocular lenses: AcrySof IQ PanOptix intraocular lens (Alcon, Ft Worth Texas) (study lens) and Trinova IOL (VSY Biotechnology GmBH, Leinfelden-Echterdingen, Germany) (control lens) those were intended for the correction of presbyopia in a primarily cataract age patient population

Department of Ophthalmology, Medipol Mega University Hospital, Istanbul, Turkey

 

 

A single-center,investigator-initiated,randomized clinical study to compare the outcomes following bilateral implantation of either the study lens or the control lens.Subjects were candidates for phacoemulsification cataract surgery or refractive lens exchange procedure with were considered for the study.Patients were randomized into the Study lens or Control lens groups using 1-to-1 block randomization.The primary effectiveness endpoint for the study is superiority of binocular distance corrected intermediate visual acuity at 60 cm, with secondary assessments including uncorrected distance, intermediate (60 cm) and near (40 cm) visual acuity, contrast sensitivity, binocular defocus curves and visual disturbance assessment.

A total of 69 patients(138 eyes) were enrolled in the study,with 50 patients(100 eyes) having exited the study, to date.35 patients were randomized into the study lens arm with 34 in the control arm.Pre-op mean uncorrected distance visual acuity was 0.3 logMAR and the mean corrected distance visual acuity was -0.1. At the final post-op visit,mean binocular UIVA in the PanOptix group was 0.1 logMAR and 0.2 in Trinova group.Mean binocular DCIVA was 0.0 logMAR for PanOptix patients and  0.1 logMAR in Trinova patients. The binocular UNVA was -0.0 for PanOptix and 0.2 logMAR in the Trinova group. Overall, PanOptix patients had a mean of 1 line better in intermediate visual acuities–both uncorrected & distance corrected, compared to the Trinova.

All patients achieved good binocular intermediate, near and distance visual acuity in both groups, with a trend toward superior DCIVA in the PanOptix patients with a mean of ±1 line improvement UIVA and ±2 lines in UCNVA.  Binocular Defocus Curve analysis demonstrated superior intermediate & near vision in the PanOptix group. The statistical analysis results found that the study achieved its primary endpoint: Superiority of binocular distance corrected intermediate visual acuity at 60 cm (DCIVA) in the PanOptix patients based on a null inferiority theory (The lower bound of the 90%CI = -0.1629, the value is outside the -0.10 threshold).