Randomized multicenter trial to assess posterior capsule opacification and glistenings in two hydrophobic acrylic intraocular lenses

Abstract

To evaluate the long-term posterior capsule opacification (PCO) formation, and glistening rate of the HOYA Vivinex (XY1) IOL compared to Alcon AcrySof (SN60WF). In this prospective, multicentric, randomized, paired-eye, open-label study, we included 87 subjects that underwent cataract surgery with IOL implantation, with 67 patients completing the 3-year follow-up. The completer population consisted of 32 subjects implanted with XY1 and 35 implanted with SN60WF. 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. 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.

Real-World Clinical Results with the Hoya Vivinex Impress Intraocular Lens with Enhanced Depth of Focus

“…Other issues have also been observed, such as the loss of pseudoaccommodative properties after 2 years and a high post-cataract rate of 100 % after 1 year with the 1CU design. In this context, a recent publication by Auffarth et al is noteworthy [8]. They demonstrated that Hoya Vivinex IOLs, specifically the XY1 design, exhibited significantly less glistening over 3 years compared to Alcon AcrySof SN60WF (Alcon, Fort Worth, TX, USA), and the rate of after-cataract was remarkably low [8].…”

“…In this context, a recent publication by Auffarth et al is noteworthy [8]. They demonstrated that Hoya Vivinex IOLs, specifically the XY1 design, exhibited significantly less glistening over 3 years compared to Alcon AcrySof SN60WF (Alcon, Fort Worth, TX, USA), and the rate of after-cataract was remarkably low [8].…”

Changes in straylight after cataract surgery

“…Of note, recent studies with 3 years of follow-up found no glistenings in Clareon IOLs and none to only a few in Vivinex IOLs. 31,32 The prediction error of eyes implanted with an XY1 IOL was, on average, slightly myopic, whereas that of eyes implanted with a CNA0T0 IOL was slightly hyperopic (À0.26 D vs 0.17 D). In this study, we used the lens constants as suggested by the manufacturer at the start of the study.…”

“…Of note, recent studies with 3 years of follow-up found no glistenings in Clareon IOLs and none to only a few in Vivinex IOLs. 31 , 32 …”

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

“…Overall lens diameter is 13.0 mm with a 6.0 mm optic zone. A proprietary posterior surface treatment increases lens/capsule adhesion to reduce the potential for PCO 11 and the textured edges of the optic reduce the likelihood of dysphotopsia. The base refractive power of the 6.0 mm optic provides distance vision, while intermediate and near vision are provided by the 3.2 mm central diffractive zone on the anterior surface.…”