Clinical evaluation of a new sinusoidal-patterned trifocal intraocular lens: 6-month outcomes

Purpose: To analyze the 6-month clinical outcomes of cataract surgery with implantation of a new trifocal intraocular lens (IOL). Methods: Prospective multicenter study enrolling a total of 202 eyes of 101 patients that underwent uncomplicated phacoemulsification cataract surgery with bilateral implantation of the Trinova Pro C IOL (VSY Biotechnology GmbH, Leinfelden-Echterdingen, Germany). Changes in refraction, uncorrected (UDVA) and corrected distance (CDVA), uncorrected (UIVA) and distance-corrected intermediate (DCIVA) and uncorrected (UNVA) and distance-corrected near visual acuity (DCNVA) during a 6-month follow-up were evaluated. The binocular defocus curve was measured at 6 months postoperatively and photopic and mesopic contrast sensitivity (CS) with and without glare. Results: Postoperative spherical equivalent was within +/- 1.00 D in 91% of eyes, respectively. Significant improvements were found in all visual acuities at 1 month postoperatively (p < 0.001). Mean 6-month postoperative monocular logMAR UDVA, UIVA and UNVA were 0.02 +/- 0.06, 0.15 +/- 0.14, and 0.14 +/- 0.12, respectively. Mean 6-month postoperative monocular logMAR CDVA, DCIVA, and DCNVA were 0.01 +/- 0.03, 0.14 +/- 0.14, and 0.14 +/- 0.12, respectively. Mean visual acuities values of 0.10 logMAR or better were found for defocus levels between +0.50 and -2.50 D. Minimal changes were observed in CS in both photopic and mesopic conditions when using the glare source (p > 0.05). Conclusions: The trifocal IOL evaluated provides an efficient distance, intermediate and near visual function in subjects undergoing uneventful cataract surgery, with stable results during a 6-month follow-up and good levels of visual quality.