Efficacy and Safety Analysis of the New Aspheric Hydrophobic Acrylic Monofocal IOL Implantation at Short-Term Follow-Up

Aim. To evaluate the results of implantation of a new hydrophobic acrylic monofocal IOL in an automated preloaded delivery system in the short-term follow-up period.Patients and methods. The prospective study included 89 patients (114 eyes) after bilateral or monolateral Clareon IOL implantation with a mean follow-up of 2.1 ± 0.4 (1–4) months. The age range was 53 to 87 (71.1 ± 5.2) years. A corneal incision of 1.8 mm was used in all cases. For implantation using the AutonoMe® system , the incision was enlarged by 0.2 mm for implantation IOL 26 D and higher. IOL optical power was calculated using the SRK/T formula; retrospective analysis was performed using the Hoffer Q, Haigis, Holladay II, Olsen, Barrett Universal II, and Kane formulas.Results. In all studied periods (1 day, 1 week and 1 month) there was statistically significant (p < 0.05) increase both of NCDVA (from 0.13 ± 0.02 in the preoperative period to 0.81 ± 0.07 in 1 month after surgical intervention), and BCDVA (from 0.32 ± 0.15 before surgery to 0.94 ± 0.11 after surgery). When assessing the percentage of eyes with an BCDVA of 0.9 or higher, a statistically significant (p < 0.05) difference was shown in all studied periods. The lowest MAE was shown for the Barrett Universal II (0.292), SRK/T (0.312) Kane (0.301), and Olsen (0.325) formulas. For the Hoffer Q and Holladay 2 formulas, MAE values were significantly higher (p < 0.05). The highest frequency of achieving the target refraction of ± 0.25 D was shown for the Barrett Universal II and Kane formulas (68 and 69 %, respectively), and the lowest for the Hoffer Q and Holladay 2 formulas (28 and 35 %, respectively). The primary endpoint of the study (BCDVA = 1.0) was achieved in 95.6 % (n = 109), with a deviation in BCVA of ± 0.1 noted in 4 eyes (3.5 %). No glistening was detected in the follow-up period up to 4 months.Conclusion. The paper presents an analysis of the first experience with the implantation of new Clareon monofocal IOLs in Russian Federation. The results of implantation of a new hydrophobic acrylic monofocal IOL in an automated preloaded delivery system showed a good clinical and functional effect, a high frequency of achieving the target result and the absence of significant side effects. The Kane, Barrett Universal II, and SRK/T formulas, using the Verion diagnostic navigation system, are recommended for calculating the optical power of the new IOL.

Intraoperative and Postoperative Intraocular Lens Opacifications: Analysis of 42545 Cases

Purpose. To assess the types and causes of intraocular lens (IOL) turbidity in a tertiary eye center. Setting. Qingdao Eye Hospital of Shandong First Medical University, Qingdao, China. Design. Retrospective case series. Methods. Patients who underwent uncomplicated phacoemulsification and IOL implantation for cataract between January 2015 and December 2019 were included. Medical records were reviewed of participants with intraoperative or postoperative IOL opacification for clinical data, artificial crystal materials, and causes of the opacification. Results. A total of 42545 IOLs were implanted in the five years, comprising 25471 (66.0%) hydrophilic IOLs, 11881 (27.9%) hydrophobic IOLs, and 2601 (6.1%) hydrophilic-hydrophobic acrylic IOLs. Among the operated eyes, 14 eyes (13 patients) experienced IOL opacification, which was permanent for 10 IOLs, including 7 (0.6%) hydrophilic IOLs (860UV) and 3 (0.2%) hydrophilic-hydrophobic acrylic IOLs (L-312). The mean interval between surgery and diagnosis of permanent opacification was 34.4 ± 18.4 (SD) months (range, 12 to 59 months). Permanent IOL clouding led to a statistically significant reduction in best corrected visual acuity (mean, 0.64 ± 0.4 logMAR; P < 0 .004 ). Acute IOL clouding occurred in four eyes during the implantation of a hydrophilic-hydrophobic acrylic IOL of L-312, 809M, or 839M and returned to transparency several hours later. All four procedures were performed in winter, with the mean outside temperature being −5.75°C. Conclusions. The rate of IOL opacification was 0.03%. Both delayed postoperative and acute intraoperative opacifications occurred with various characteristics in IOLs made of different materials and designs. Clinicians should be aware of this risk for cataract surgery.

Silicone Oil Adhesion to Hydrophobic Acrylic Intraocular Lenses: A Comparative Laboratory Study of a New versus an Established Hydrophobic Acrylic Intraocular Lens Material

Background. In vitro assessment of silicone oil adhesion to a new hydrophobic acrylic intraocular lens (IOL) material, the Clareon model CNA0T0, compared with the established AcrySof model SN60WF was carried out. Methods. Silicone oil adhesion was assessed for two types of IOLs, Clareon CNA0T0 (n = 10) and AcrySof SN60WF (n = 10). Lenses were immersed in an aqueous sodium chloride solution for 12 hours and then incubated at room temperature in silicone oil for 12 hours. The lenses were washed with distilled water and photographed at 25x magnification using a microscope. The percent coverage was calculated by dividing the area of oil coverage by the total surface area of the lens. Results. Silicone oil adhesion to the surface of the CNA0T0 lens ranged from 4% to 22%, with a mean ± SD coverage of 8% ± 4%. Silicone oil adhesion to the surface of the SN60WF lens ranged from 1% to 17%, with a mean coverage of 9% ± 4%. The silicone oil adhesion of CNA0T0 was equivalent to that of SN60WF ( P > 0.05 ). Conclusions. The new Clareon model CNA0T0 IOL has silicone oil adhesion and interaction that are equivalent to the established AcrySof IOL.

Multifocal IOL Explantation in Patients with Opaque Lentis after Refractive Lens Exchange

Purpose We describe the outcomes of intraocular lens (IOL) explantation in a cluster of opaque multifocal Lentis LS-313 following refractive lens exchange (RLE). Methods Single-centre, single-surgeon, retrospective case series. Results The study enrolled 10 eyes of 10 patients, 6 male and 4 female. All patients had uneventful RLE with multifocal IOL implantation. The mean patient age at the time of RLE was 53 years ± 2.52 (SD). Two eyes had YAG laser capsulotomy prior explantation. The mean interval between the initial RLE and IOL explantation was 5.4 years ± 1.4 (SD). IOL exchange was performed in all eyes in one procedure. Five eyes had in the bag hydrophobic acrylic IOL (3 multifocal and 2 monofocal) three eyes had 3-piece hydrophobic acrylic IOL in the ciliary sulcus and two had an anterior chamber IOL. Intraoperatively one patient had weak zonules and two patients had zonular dehiscence and required anterior vitrectomy. The mean preoperative CDVA was 0.25 ± 0.15 (SD) logMAR and at the final follow-up, improved to 0.00 ± 0.07 (SD) logMAR (p < 0.01). Light microscopy with von Kossa stain confirmed IOL calcification. No postoperative complications were recorded. Conclusions IOL exchange appears to be a feasible and safe surgical option for multifocal IOL opacification. However, patients must be warned of additional intraoperative risks including zonular dialysis, vitreous loss, retinal detachment and need for potential ACIOL with its associated sequel of complications. Moreover, YAG laser capsulotomy should be considered carefully as increases the chances of intraoperative complications and restricts the surgical options of secondary IOL insertion, including in-the-bag IOL exchange with MFIOL.

Comparative analysis of in vitro accelerated glistening formation in foldable hydrophobic intraocular lenses

Purpose To analyse and compare the propensity to form glistenings in 4 different types of hydrophobic acrylic intraocular lenses (IOLs): Alcon AcrySof ® MA60AC, HOYA iSert® PC-60AD, Bausch&Lomb enVista, and Kowa Avansee™ PU6A. Methods We used an accelerated laboratory method to create glistenings. IOLs were first immersed in saline at 45 °C for 24 h and then at 37 °C for 2.5 h. Microvacuole (MV) density and size were documented and calculated using an image analysis program. Results Median density of glistenings [MV/mm2] for Alcon AcrySof ® MA60AC was 623 (range 507–804), for HOYA iSert® PC-60AD 1358 (range 684–2699), for Bausch&Lomb enVista 2 (range 1–2), and for Kowa Avansee™ PU6A 1 (range 1–4). The prevailing MV size was: 0–5 µm for Hoya IOLs, 5–10 µm for Alcon IOLs, 20–50 µm for Bausch&Lomb IOLs, and 5–50 µm for Kowa IOLs. Conclusions Glistenings could be induced in all studied IOLs using the accelerated laboratory method. The Alcon AcrySof ® MA60AC and HOYA iSert® PC-60AD IOLs showed MV of high density, while the glistenings in the Hoya IOLs were smaller in size compared to the Alcon IOLs. The MV density was minimal in the Bausch&Lomb enVista and Kowa Avansee™ PU6A IOLs. The propensity of the Alcon AcrySof ® MA60AC IOLs to form glistenings in vitro correlated with the findings of clinical results that are already published.

Quantitative evaluation of microvacuole formation in five intraocular lens models made of different hydrophobic materials

In this laboratory study, we assessed the resistance to microvacuole (glistening) formation in hydrophobic intraocular lenses (IOLs). Glistenings were induced in five lenses each of five different hydrophobic acrylic IOL models, using an established in vitro laboratory model: 800C (Rayner, Worthing, UK), AcrySof SN60WF (Alcon, Fort Worth, USA), Tecnis ZCB00 (Johnson & Johnson Vision, Santa Ana, USA), Vivinex XY1 (Hoya, Tokyo, Japan) and CT Lucia 611P (Zeiss, Oberkochen, Germany). We evaluated the number of microvacuoles per square millimeter (MV/mm2) in the central part of each IOL. Results were analyzed statistically, and mean glistening numbers were ranked, with the highest in the SN60WF which had 66.0 (±45.5) MVs/mm, followed by the 611P with 30.7 (±8.4) MVs/mm2. The 800C and XY1 showed comparable values of 2.0 (±3.6) and 2.7 (±2.4) MVs/mm2, respectively. ZCB00 had the lowest number with 0.9 (±0.6) MVs/mm2. This study shows that the resistance to glistening formation differs depending on the hydrophobic acrylic copolymer composition of the IOL material. Some IOLs from current clinical use are still prone to develop glistenings whereas others, including the ZCB00, 800C and XY1 show high resistance to microvacuole formation.