Visual Performance of a Polynomial Extended Depth of Focus Intraocular Lens

Abstract

Purpose: To clinically evaluate a new extended depth of focus intraocular lens (ISOPURE, PhysIOL) with optic design modification based on a unique polynomial concept to improve intermediate vision while keeping the quality of distance vision equal to a monofocal lens. Methods: 18 patients (11 female, 7 male, mean age of 69.4 years) with bilateral cataract and regular corneal astigmatism ≤ 1.0 D underwent bilateral cataract surgery with ISOPURE implantation. Patients were followed for up to 6 months. Measured parameters were uncorrected (UDVA) and corrected distance visual acuity (CDVA), uncorrected (UIVA) and distance-corrected intermediate visual acuity at 80 cm and 66 cm (DCI80VA, DCI66VA) subjective refraction, defocus curve, tolerance of cylinder induction, and contrast sensitivity. The data from all implanted eyes (all-eyes) and a subset only including the first eye implanted for each patient were analysed. Results: The mean manifest refraction spherical equivalent (MRSE) decreased from 1.05 D pre-operatively to −0.15 D at the 4 -6 month assessment, with 80.6% of eyes within ±0.50 D of emmetropia. At the final follow-up, mean (SD) monocular CDVA was −0.06 (0.04) logMAR, DCI80VA was 0.18 (0.08) logMAR and DCI66VA was 0.27 (0.13) logMAR. Despite a cylinder induction of −0.50 D, uncorrected distance visual acuity of 0.02 logMAR was still achieved. Conclusion: The ISOPURE intraocular lens provides excellent distance corrected visual acuity for far and intermediate distances along with high contrast sensitivity and good tolerance of residual refractive cylinder.

Clinical and Aberrometric Evaluation of a New Monofocal IOL with Intermediate Vision Improvement

“…Stodulka and Slovak [ 20 ] recently published the clinical outcomes of patients implanted with the IsoPure IOL. Their clinical study confirmed the predicted gain at intermediate and comparable visual acuity at distance and normal contrast sensitivity.…”

“…In another study, Son et al showed that the EDOF IOL group had better-uncorrected distance visual acuity than the monofocal lens group for the unexpected postoperative residual refractive errors like spherical equivalent values of +0.50 D or −0.50 D [ 22 ]. Stodulka and Slovak [ 20 ] published the visual acuity obtained with the IsoPure IOL after the induction of different values of the positive and negative cylinder and showed that it dependent on the axis, with superior vision at an axis 180° and similar results at axis of 90° in comparison to the multifocal IOLs. Residual cylinders from +1.0 D to −1.25 D should therefore have no significant impact on visual acuity (better than 0.2 logMAR), and patient satisfaction and the lens may present an advantage.…”

Clinical Outcomes of a New Non-Diffractive Extended Depth-of-Focus Intraocular Lens Targeted for Mini-Monovision

“…To our knowledge, there is one in-vitro study 20 and two clinical studies with small samples. 17 , 18 Łabuz et al 20 performed an in-vitro comparison of four EDOF IOLs [Tecnis Eyhance ICB00 (Johnson and Johnson), AE2UV/ZOE (Eyebright Medical Technology), RayOne EMV (Rayner) and the isofocal EDOF lens (BVI)] and a standard monofocal lens [Tecnis ZCB00 (Johnson and Johnson)]. They found that the performance of the isofocal EDOF lens at −1.0 D was superior to that of the monofocal IOL.…”

“…These observations are clinically confirmed by the defocus curve in our study (see Figure 4 ). Stodulka et Slovak 17 studied 18 patients implanted with the isofocal EDOF lens 4–6 months after surgery. In another small clinical study (n=21), Bova and Vita 18 compared the isofocal EDOF lens with a monofocal IOL (Tecnis PCB00).…”

“…This modification of the spherical aberrations is known as isofocal technology. Only limited clinical data are currently available: Stodulka et Slovak 17 reported promising results in terms of visual acuity and contrast in a small cohort of patients (n=18) as did Bova et Vita 18 (n=21). Neither study used mini-monovision.…”