Randomized Multicenter Trial To Assess Posterior Capsule Opacification And Glistenings In Two Hydrophobic Acrylic Intraocular Lenses

The purpose of this multicentric clinical trial was to evaluate the clinical acceptability, long-term PCO formation, and the glistening rate of the HOYA Vivinex™ XY1 IOL (HOYA Surgical Optics, Tokyo, Japan) compared to the Alcon AcrySof® IOL (Alcon Laboratories, Fort Worth, Texas, USA). The study hypothesis proposed that the HOYA Vivinex™ XY1 IOL, compared to the AcrySof® IOL would demonstrate a reduction in glistening, and comparable PCO, visual acuity, and contrast sensitivity

Dept. of Ophthalmology, University of Heidelberg, Heidelberg, German

Cochin Hospital, Paris, France

Institut Ophtalmologique-Sourdille Atlantique, Saint-Herblain, France

Dept. of Ophthalmology, Goethe University, Frankfurt Am Main, Germany

In this clinical Study we included 87 subjects that underwent cataract surgery with IOL implantation, with 67 patients completing the 3-year follow-up. The complete trial population consisted of 32 subjects implanted with XY1 and 35 implanted with SN60WF (AcrySof® IOL). Primary endpoints consisted of the evaluation of glistenings and measurement of PCO. Secondary outcomes included Best Corrected Distance Visual Acuity (BCVA), Contrast Acuity (CA), uncorrected visual acuities, subjective refraction, medical and lens complication rates, adverse events, and optical/visual symptoms. Follow-up visits occurred at 6-months, 1-, 2- and 3-years post surgery.

At 3-years follow-up, mean PCO score was 0.121 ± 0.193 for eyes implanted with Vivinex versus 0.239 ± 0.463 for AcrySof (p = 0.026). The Vivinex IOL showed statistically significantly lower glistening occurrence through 3-years postoperatively (0.14 ± 0.26) compared to AcrySof (1.79 ± 1.43; p < 0.0001). Postoperative visual acuities improved from baseline in both IOL groups (p < 0.0001), and remained stable through the 3-year follow-up period

Eyes implanted with a HOYA Vivinex IOL exhibited significantly lower occurrence of glistening at 3-years versus Alcon AcrySof (p < 0.0001). Incidence of PCO was very low and comparable in both Vivinex and AcrySof eyes.