Material Analysis of Explanted Calcified Silicone Intraocular Lenses in Association with Asteroid Hyalosis.

INTRODUCTION: The aim of this study was to analyze posterior surface opacification in explanted silicone intraocular lenses (IOLs) with clinicopathologic correlation to asteroid hyalosis. METHODS: In a laboratory setup, 12 explanted silicone IOLs underwent laboratory analyses, including light microscopy, scanning electron microscopy (SEM), and energy-dispersive X-ray spectroscopy for elemental composition (EDX). Relevant clinical data were obtained for each case, including gender, age at IOL implantation, dates of implantation and explantation, as well as history of neodymium-dopped yttrium aluminum garnet (Nd:YAG) laser treatments or other opacification removal attempts. High-resolution optical coherence tomography (OCT) images were obtained in vitro with an anterior segment OCT device (Anterion, Heidelberg Engineering, Heidelberg, Germany). RESULTS: Calcification located at the posterior optic surface of each lens was identified through SEM and EDX analyses, revealing deposits composed of hydroxyapatite. In all cases, IOL polishing using Nd:YAG laser had been attempted prior to IOL exchange. The clinical functional data showed that this type of IOL opacity led to increase in straylight and subjective symptoms of glare. CONCLUSIONS: Silicone IOLs can develop posterior surface calcification in eyes with asteroid hyalosis. There are mechanical techniques of cleaning the IOL surface but in many cases, IOL explantation is the only sustainable way to reduce the patients' straylight levels and glare symptoms. Due to the risk of posterior surface calcification, silicone IOL implantation should be avoided in eyes with asteroid hyalosis.

Cataract Classification Systems: A Review.

Cataract is among the leading causes of visual impairment worldwide. Innovations in treatment have drastically improved patient outcomes, but to be properly implemented, it is necessary to have the right diagnostic tools. This review explores the cataract grading systems developed by researchers in recent decades and provides insight into both merits and limitations. To this day, the gold standard for cataract classification is the Lens Opacity Classification System III. Different cataract features are graded according to standard photographs during slit lamp examination. Although widely used in research, its clinical application is rare, and it is limited by its subjective nature. Meanwhile, recent advancements in imaging technology, notably Scheimpflug imaging and optical coherence tomography, have opened the possibility of objective assessment of lens structure. With the use of automatic lens anatomy detection software, researchers demonstrated a good correlation to functional and surgical metrics such as visual acuity, phacoemulsification energy, and surgical time. The development of deep learning networks has further increased the capability of these grading systems by improving interpretability and increasing robustness when applied to norm-deviating cases. These classification systems, which can be used for both screening and preoperative diagnostics, are of value for targeted prospective studies, but still require implementation and validation in everyday clinical practice.

Altering chromatic aberration: how this latest trend in intraocular-lens design affects visual quality in pseudophakic patients.

BACKGROUND: Chromatic aberration of the eye results from the dispersion of polychromatic light at the interfaces of ocular media. An intraocular lens (IOL) based approach utilizing the diffractive-multifocal principle has been proposed for its correction, but the clinical evidence on the impact of reducing or increasing chromatic aberration on the visual quality of pseudophakic patients remains scarce. METHODS: In this cross-sectional study, longitudinal chromatic aberration (LCA) effects were studied monocularly in 37 patients implanted with a monofocal lens. LogMAR corrected distance visual acuity (VA) and defocus curve at the + 1.0 D to - 2.0 D range were assessed. Contrast sensitivity (CS) was evaluated at far and at four spatial frequencies. Measurements were performed with the eye's natural conditions, as well as with increased and corrected (by the same amount) LCA, which was altered by introducing zero-power trial triplets. RESULTS: The mean (± standard deviation) logMAR VA was - 0.11 ± 0.07 for the natural condition, - 0.13 ± 0.07 for the LCA-corrected eye, and - 0.06 ± 0.08 for the eye with increased LCA. A sharp decline of the defocus tolerance was found after the LCA correction with the VA value of 0.38 ± 0.15 logMAR at - 1.5 D. However, for the natural and increased LCA, it was 0.32 ± 0.16 logMAR and 0.25 ± 0.13 logMAR, respectively. CS was improved at all spatial frequencies after the LCA correction, which was closely followed by the natural-eye performance. Increased LCA resulted in reduced CS, mainly at higher spatial frequencies. CONCLUSIONS: We demonstrated that elevating chromatic aberration above the natural level of monofocal patients extends their depth of focus while causing a measurable albeit minimal reduction in visual function. Still, the observed changes indicate that neither correction nor increase of LCA yields a substantial clinical effect on distance VA and CS in monofocal pseudophakia.

In vivo comparison of implantation behavior and laboratory analysis of two preloaded intraocular lens injectors.

PURPOSE: We evaluated implantation behavior and injector damage of two different IOL injector systems, the Multisert and the AutonoMe. DESIGN: Prospective, randomized, comparative study with laboratory investigation. METHODS: We examined used injectors from 48 bilateral cataract cases and assessed video recordings of each Implantation. All eyes were intraindividually randomized for treatment with one of the two IOL injectors. Implantation videos were reviewed for inadvertent events and the time for different implantation steps was determined. The injector nozzle tips were examined using light and scanning electron microscopy (SEM). Damage was graded using the Heidelberg Score for IOL injector damage (HeiScore). Three months postoperatively, IOLs were assessed for material changes. RESULTS: Implantation was without critical events in 96 of 96 eyes. Mean implantation time was 41.90 ± 7.11 s with the Multisert and 52.22 ± 12.06 s with the AutonoMe. In the AutonoMe group, we observed 4 eyes (8.3%) with a failed docking attempt, 28 eyes (58.3%) with a haptic adherence, one case (2.1%) of straight leading haptic and 2 cases (4.2%) of intrawound IOL manipulation. There were no events observed in the Multisert group. The mean HeiScore values were 0.87 ± 0.61 and 3.68 ± 0.47 for the AutonoMe and Multisert. 3 months postoperatively, IOL material changes were absent. CONCLUSIONS: Both injectors allowed safe and controlled implantation. Using Multisert, implantation behavior was more consistent. The injectors showed different damage profiles with a higher damage score for the Multisert.The study is registered at the German Clinical Trials Register (Deutsches Register Klinischer Studien; reference number: DRKS00007837).

Differential Diagnosis of Changes in Intraocular Lenses. / Differenzialdiagnostik von Veränderungen in Intraokularlinsen.

Differentiating between various intraocular lens (IOL) changes can be a challenge. In particular, certain IOL models carry the risk of late postoperative calcification. A major cause of IOL exchange surgery could be avoided if appropriate modifications were made during the IOL manufacturing process. The use of a hydrophilic acrylate carries the risk of IOL calcification, especially when a secondary procedure, such as a pars plana vitrectomy or other procedures using gas or air, is performed. In secondary IOL calcification, there is a wide range of opacification patterns, which are usually located in the centre on the anterior surface of the IOL or sometimes elsewhere. Often, granular deposits accumulate just below or on the surface of the IOL, leading to significant deterioration in visual quality and eventually requiring IOL exchange surgery. Therefore, in the case of eyes requiring secondary surgical intraocular intervention in the future, the use of hydrophilic IOLs should be critically evaluated. With regard to hydrophobic IOL materials, there are clear differences in the susceptibility to the formation of glistenings. Over time, there has been a significant decrease in glistening formation over the past 30 years due to optimisation of the material. With hydrophobic IOLs, special care should also be taken to avoid mechanical damage. In general, the only treatment option for functionally-impairing IOL opacification is surgical lens exchange, which carries potential risks of complications. In cases with a low degree of functional impairment, and especially in eyes with additional ocular diseases, it may be difficult to weigh the risk of additional surgery against the potential benefit. In some cases, it may be more appropriate not to perform an IOL exchange despite the IOL opacification. Recent visualisation methods that allow high-resolution analysis of the opacities in vivo and in vitro may be used in the future to estimate the functional effects of various IOL material changes on the optical quality.

Clinical Characteristics of Patients with Intraocular Lens Calcification after Pars Plana Vitrectomy.

AIM: To determine the clinical risk factors that may increase the occurrence of intraocular lens (IOL) calcification in patients who had undergone pars plana vitrectomy (PPV). METHODS: The medical records of 14 patients who underwent IOL explantation due to clinically significant IOL opacification after PPV were reviewed. The date of primary cataract surgery, technique and implanted IOL characteristics; the time, cause and technique of PPV; tamponade used; additional surgeries; the time of IOL calcification and explantation; and IOL explantation technique were investigated. RESULTS: PPV had been performed as a combined procedure with cataract surgery in eight eyes and solely in six pseudophakic eyes. The IOL material was hydrophilic in six eyes, hydrophilic with a hydrophobic surface in seven eyes and undetermined in one eye. The endotamponades used during primary PPV were C2F6 in eight eyes, C3F8 in one eye, air in two eyes and silicone oil in three eyes. Two of three eyes underwent subsequent silicone oil removal and gas tamponade exchange. Gas in the anterior chamber was detected in six eyes after PPV or silicone oil removal. The mean interval between PPV and IOL opacification was 20.5 ± 18.6 months. The mean BCVA in logMAR was 0.43 ± 0.42 after PPV, which significantly decreased to 0.67 ± 0.68 before IOL explantation for IOL opacification (p = 0.007) and increased to 0.48 ± 0.59 after the IOL exchange (p = 0.015). CONCLUSIONS: PPV with endotamponades in pseudophakic eyes, particularly gas, seems to increase the risk for secondary IOL calcification, especially in hydrophilic IOLs. IOL exchange seems to solve this problem when clinically significant vision loss occurs.

Capsule Dynamics, Implantation, and Explantation of the Smaller Incision, New-Generation Implantable Miniature Telescope: a Miyake-Apple Study.

PURPOSE: The smaller incision, new-generation implantable miniature telescope is a novel implant to optimize vision in retinal patients with central vision loss. Using Miyake-Apple techniques we visualized the device implantation, repositioning, and explantation, while noting capsular bag dynamics. METHODS: Using the Miyake-Apple technique, we assessed capsular bag deformation after successful implantation of the device in human autopsy eyes. We assessed rescue strategies for converting a sulcus implantation to a capsular implantation and explantation strategies. We noted the occurrence of posterior capsule striae, zonular stress, and the haptics' arc of contact with the capsular bag after implantation. RESULTS: Acceptable zonular stress was observed during the successful implantation of the SING IMT. When it was implanted in the sulcus, one could reposition the haptics into the bag with two spatulas using counter-pressure in an effective strategy despite inducing tolerable, medium zonular stress. A similar technique, in reverse, allows safe explantation without damaging the rhexis or the bag, while inducing similar medium, tolerable zonular stress. In all eyes we examined, the implant considerably stretches the bag, inducing a capsular bag deformation and posterior capsule striae. CONCLUSION: The SING IMT can be safely implanted without significant zonular stress. In sulcus implantation and explantation, repositioning of the haptic is achievable without perturbing zonular stress using the presented approaches. It stretches average-sized capsular bags to support its weight. This is achieved by an increased arc of contact of the haptics with the capsular equator.

Refractive outcomes after DMEK: meta-analysis.

In this meta-analysis and systematic literature review of refractive outcomes after Descemet membrane endothelial keratoplasty (DMEK), the extent of the refractive shift and an overview of reasons for refractive shift after DMEK are provided. The PubMed library was screened for articles containing the terms "Descemet membrane endothelial keratoplasty," "DMEK," "Descemet membrane endothelial keratoplasty combined with cataract surgery," "triple-DMEK" combined with "refractive outcomes," "refractive shift," and "hyperopic shift." The refractive outcomes after DMEK were analyzed and compared using a fixed and random effects model. The overall mean change of the spherical equivalent outcome when compared with the preoperative value in cases of DMEK or when compared with the preoperative target refraction in cases of DMEK combined with cataract surgery was +0.43 diopters (D) (95% CI, 0.31-0.55). When DMEK is combined with cataract surgery, a target refraction of -0.5 D is recommended to achieve emmetropia. Changes in the posterior corneal curvature are identified as the main cause of the refractive hyperopic shift.

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

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.

Automatic Quantitative Assessment of Lens Opacities Using Two Anterior Segment Imaging Techniques: Correlation with Functional and Surgical Metrics.

The purpose of this study is to quantitatively assess lens opacity, using a swept-source optical coherence tomography (SS-OCT) device for anterior segment assessment, and establish the correlation with Scheimpflug imaging, corrected distance visual acuity (CDVA) and cumulative dissipated energy (CDE). This prospective cross-sectional single-center study enrolled 51 patients (51 eyes) with crystalline lens opacity. Patients with previous ocular surgery, pathologies or general disorders affecting vision were excluded. Eyes were scanned with an SS-OCT device, and lens densitometry was automatically analyzed using a custom MATLAB script which examined lens density, nuclear density and linear density. The same analyses were performed on Scheimpflug images. Preoperative CDVA and CDE during phacoemulsification were recorded. Spearman's (ρ) and Pearson's (r) correlation coefficients were assessed according to data normality. Statistically significant correlations were established between SS-OCT and Scheimpflug imaging using lens analysis (ρ = 0.47, p < 0.001), nuclear analysis (ρ = 0.73, p < 0.001) and linear analysis (r = 0.44, p < 0.001). A significant correlation with CDE was found with all the SS-OCT methods (r = 0.57, p < 0.001). Only the nuclear analysis of the SS-OCT scans (Tb = −0.33, p < 0.01) and Pentacam Nucleus Staging (Tb = −0.26, p < 0.05) showed a statistically significant correlation with CDVA. Good inter-device agreement in lens densitometry was found. However, SS-OCT yielded improved lens imaging compared with the Scheimpflug device and a higher correlation with clinical parameters. Thus, high-resolution SS-OCT has the potential to become a preferable option for automatic cataract grading and preoperative planning.

Ophthalmic viscosurgical device interaction with two hydrophobic acrylic intraocular lenses of different equilibrium water content.

Ophthalmic viscosurgical device (OVD) is used during intraocular surgery to protect ocular tissue. It requires complete removal from the eye by the end of surgery to avoid postoperative complications. This study compares the interaction of a cohesive OVD with two different intraocular lenses (IOLs) of different equilibrium water content. In this laboratory study on porcine cadaver eyes, the capsular bags and anterior chambers of each eye were filled with fluorescein-stained OVD. Following implantation of 10 IOLs each of Clareon CNA0T0 and AcrySof SN60WF (Alcon Laboratory, Fort Worth, USA) IOLs, the OVD was removed using the irrigation/aspiration mode. The OVD removal was timed and differences between the both IOL groups were compared. OVD removal time ranged from 18 to 40 s (mean ± SD, 26.4 ± 6.8 s) and from 16 to 39 s (mean ± SD, 23.6 ± 6.6 s) for eyes implanted with a CNA0T0 and a SN60WF IOL, respectively, without a statistically significant difference between the groups, P > 0.05. Cohesive OVD removal times were similar between the CNA0T0 and SN60WF groups. Surgeons should experience no differences regarding the interaction between cohesive OVDs and IOLs made from the new Clareon material compared to the established AcrySof material.

Development and Verification of an Adjustment Factor for Determining the Axial Length Using Optical Biometry in Silicone Oil-Filled Eyes.

The aim of this prospective clinical study was to establish and verify an adaptation for axial length (AL) measurement in silicone oil (SO)-filled pseudophakic eyes with a Scheimpflug and partial coherence interferometry (PCI)-based biometer. The AL was measured with a Pentacam AXL (OCULUS Optikgeräte GmbH, Wetzler, Germany) and IOLMaster 700 (Carl Zeiss Meditec, Jena, Germany). The coefficients of variation (CoV) and the mean systematic difference (95% confidence interval (CI)) between the devices were calculated. After implementing a setting for measuring AL in tamponaded eyes with a Pentacam based on data of 29 eyes, another 12 eyes were examined for verification. The mean AL obtained with the Pentacam was 25.53 ± 1.94 mm (range: 21.70 to 30.76 mm), and with IOLMaster, 24.73 ± 1.97 mm (ranged 20.84 to 29.92 mm), resulting in a mean offset of 0.80 ± 0.08 mm (95% CI: 0.77, 0.83 mm), p < 0.001. The AL values of both devices showed a strong linear correlation (r = 0.999). Verification data confirmed good agreement, with a statistically and clinically non-significant mean difference of 0.02 ± 0.04 (95% CI: -0.01, 0.05) mm, p = 0.134. We implemented a specific adaptation for obtaining reliable AL values in SO-filled eyes with the Pentacam AXL.

Laboratory and Clinical Experience With a Diffractive Trifocal Intraocular Lens Sutured to an Artificial Iris.

PURPOSE: To determine in vitro, using a translational research approach before realizing the procedure in a patient with iatrogenic aphakia and partial aniridia, whether suturing a trifocal intraocular lens (IOL) to an artificial iris degrades the IOL's optical quality. METHODS: Optical quality was analyzed by measuring the modulation transfer function (MTF) at a 3-mm aperture and at 50 and 100 lp/mm spatial frequencies. The FineVision Pod F GF IOL (PhysIOL) was assessed in two powers: two +20.00 diopters (D) (20A and 20B IOLs) and two +30.00 D (30A and 30B IOLs). The IOLs' decentration in relation to the artificial iris's center was evaluated. The laboratory results provided empirical evidence in the informed consent for surgical intervention in a patient with iatrogenic aphakia and iris defect in one eye. Clinical results were measured using the parameter of corrected distance visual acuity plus a patient self-assessment of the cosmetic appearance of the operated eye. RESULTS: The 20A and 20B IOLs demonstrated a mean MTF reduction of up to 1.1%, whereas the 30A and 30B IOLs showed a decrease of up to 5.2% for both spatial frequencies. All lenses showed good centration levels. In the clinical case, the patient showed corrected distance visual acuity, distance-corrected near visual acuity, and distance-corrected intermediate visual acuity of 0.20, 0.20, and 0.22 logMAR, respectively. The patient was satisfied with the cosmetic outcome. CONCLUSIONS: There was merely a slight reduction in trifocal IOL optical quality after it was sutured to an artificial iris. Clinically, the combined implantation of the artificial iris and FineVision IOL provided good functional and cosmetic outcomes. [J Refract Surg. 2022;38(1):61-68.].

Scheimpflug Versus Optical Coherence Tomography to Detect Subclinical Corneal Edema in Fuchs Endothelial Corneal Dystrophy.

PURPOSE: The purpose of this research was to compare the ability of Scheimpflug and anterior segment optical coherence tomography (OCT) in detecting subclinical corneal edema in patients with Fuchs endothelial corneal dystrophy (FECD) without clinical corneal edema. METHODS: In this single-center, consecutive case series, 47 eyes of 29 patients with FECD were analyzed. The main outcome measures were anterior/posterior keratometry and central/thinnest corneal thickness. The criteria for subclinical corneal edema were loss of regular isopachs, displacement of the thinnest point of the cornea, and presence of posterior surface depression. Tomographic analyses were performed using Scheimpflug imaging (Pentacam HR) and OCT (anterior segment swept-source optical coherence tomography). RESULTS: The measurement of the continuous variables revealed a significant difference between the 2 devices. The anterior curvature was steeper and the posterior curvature was flatter when measured with OCT ( P < 0.001). The OCT showed a lower central corneal thickness and thinnest corneal thickness ( P < 0.001). The agreement between both devices to detect subclinical corneal edema was high. The interdevice reliability for loss of parallel isopachs as measured by Cohen kappa coefficient was 0.84; for the displacement of the thinnest point of the cornea, it was 0.6, and for the focal posterior corneal surface depression, it was 0.62. Subclinical corneal edema was detected in 72.3% of the patients with both devices. In only 2 cases (4.3%), subclinical corneal edema was detected by one of the devices. CONCLUSIONS: Scheimpflug and OCT imaging were both able to detect tomographic patterns of subclinical corneal edema. Therefore, both devices can help decision-making, favoring early endothelial keratoplasty in symptomatic patients with FECD without clinical corneal edema.

Pupil dynamics after in-the-bag versus anterior and retropupillary iris-fixated intraocular lens implantation.

An Intraocular Lens (IOL) fixated on the iris either anteriorly, as a phakic IOL, or posteriorly, as an aphakic IOL, can influence pupil motility. In this interventional case series study, we evaluated pupil size under different levels of illumination (scotopic = 0.04 lx, low-mesopic = 0.4 lx and high-mesopic = 4 lx) for anterior iris-claw IOL fixation for correcting myopia or hyperopia (IFPH), retropupillary iris-claw IOL fixation to correct aphakia or as treatment for late in-the-bag IOL dislocation/subluxation (IFRP), and capsular-fixation IOL in-the-bag implantation (IB). Pupil size was measured preoperatively for the IFPH- and IB-group as well as 6 months after surgery for all groups. We analyzed a total of 70 eyes: 22 eyes of 11 patients with phakic IOLs, 22 eyes of 20 patients in the IFRP group and 26 eyes of 13 patients in the IB group. Both IFPH and IB showed a smaller postoperative scotopic pupil size, compared with the preoperative values. When compared to postoperative values of IB and IFPH, IFRP showed a significantly smaller postoperative scotopic pupil size (IFPH: 5.89 ± 0.83 mm, IFRP: 4.37 ± 0.83 mm, IB: 5.34 ± 0.98 mm, p < 0.001) while no differences were seen at high-mesopic lighting. Neither of the surgical techniques seems to impair the constriction of the pupil.

Laboratory Investigation of Preclinical Visual-Quality Metrics and Halo-Size in Enhanced Monofocal Intraocular Lenses.

INTRODUCTION: This study aims to compare preclinical visual-quality metrics and halo size of intraocular lenses (IOL) with enhanced intermediate vision to a standard monofocal lens. METHODS: Three monofocal- IOL models with an extended-depth-of-focus (EDoF) intended for monocular implantation (Tecnis ICB00, AE2UV/ZOE, and IsoPure) and one for monovision (RayOne EMV) were compared against a standard monofocal lens (Tecnis ZCB00). An optical-metrology station was used in the assessment of IOLs' optical quality in polychromatic light. The imaging quality was compared with metrics derived from the optical transfer function. Halo size was estimated from the projection of the point spread function under scotopic pupil. RESULTS: The monofocal IOL showed the highest image quality at the far focus. The ICB00's, the AE2UV/ZOE's, and the IsoPure's performance at - 1D was superior to that of the monofocal lens. The monocular defocus tolerance of the RayOne EMV was comparable with that of the ZCB00. The RayOne EMV's intermediate range was improved in a monovision configuration (- 1D offset). This approach, however, yielded the largest halo area, i.e., 53% of the ZCB00's halo, compared to 34% for the IsoPure, 14% for the AE2UV/ZOE, and 8% for the ICB00. CONCLUSION: The mono-EDoF models have a clear advantage over the standard monofocal lens by expanded imaging capability beyond - 0.5D. Although the RayOne EMV provided the largest (binocular) visual-range extension, it was at the expense of monocular vision and higher susceptibility to halo. The ICB00's and the AE2UV/ZOE's halo-profile was similar to that of the ZCB00, indicating their low potential to induce photic phenomena.

High-addition segmented refractive bifocal intraocular lens in inactive age-related macular degeneration: A multicenter pilot study.

This multicenter, open-label study aimed to determine the safety and functional outcome of a high-addition segmented refractive bifocal intraocular lens (IOL) in late inactive age-related macular degeneration (AMD). Twenty eyes of 20 patients were enrolled and followed until 12 months after the intervention. Patients underwent cataract surgery with implantation of a LS-313 MF80 segmented refractive bifocal intraocular lens with a near addition of +8.0 D (Teleon Surgical Vertriebs GmbH, Berlin, Germany). The main outcome measures were distance corrected near visual acuity (DCNVA) and safety as determined by intra- and post-operative complications. Secondary outcomes included distance corrected visual acuity (CDVA), uncorrected distance visual acuity (UDVA), uncorrected near visual acuity (UNVA), the need for magnification to read newspaper, preferred reading distance, speed and performance (logRAD), as well as patient satisfaction. Mean DCNVA improved from 0.95 (±0.19) to 0.74 (±0.35) logMAR, until 6 months after surgery, P<0.05. CDVA improved from 0.70 (±0.23) to 0.59 (±0.30) logMAR, UDVA from 0.94 (±0.25) to 0.69 (±0.34) logMAR, UNVA from 1.08 (±0.19) to 0.87 (±0.43) logMAR. The mean need for magnification decreased from 2.9- to 2.3-fold, preferred reading distance from 23 to 20 cm. No intraoperative complications occurred during any of the surgeries. One patient lost > 2 lines of CDVA between 6 and 12 months, in another case, the study IOL was exchanged for a monofocal one due to dysphotopsia and decreased CDVA. Implantation of a segmented refractive bifocal IOL with +8.0 D addition improves near and distance vision in patients with late AMD and has a satisfactory safety profile.

Preloaded injectors used in a clinical study: videographic assessment and laboratory analysis of injector nozzle damage.

PURPOSE: To evaluate quality and duration of implantation of 2 preloaded intraocular lens (IOL) injectors and assess postimplantation damage. SETTING: The David J. Apple Center for Vision Research, Department of Ophthalmology, University of Heidelberg, Heidelberg, Germany. DESIGN: Prospective, randomized, comparative study with laboratory investigation. METHODS: Implantation videos and postuse injectors from 60 paired eyes of 30 bilateral cataract patients were included. Patient eyes were randomly assigned for implantation with 2 different preloaded injectors: the AutonoMe with a Clareon IOL (Alcon Laboratories, Inc.) and the iSert with a Vivinex IOL (Hoya Corp.). Videos were reviewed for events during the implantation procedure, and the duration of each step of implantation. Injector nozzles were examined under light and scanning electron microscopy. Damage was graded and correlated with the IOL power. Three months postoperatively IOLs were assessed for material changes. RESULTS: IOL delivery was without any critical events in 60 of the 60 eyes. The implantation took 56 seconds with the AutonoMe and 44 seconds with the iSert (P < .05). Most AutonoMe injectors (29; 97%) showed no damage or slight deformation. In most of the iSert injectors (25; 80%), short or extended cracks were present, and damage lengths correlated with the IOL power. All IOLs were free of material changes, including glistenings, 3 months postoperatively. CONCLUSIONS: Both preloaded IOL injectors allowed a safe and convenient IOL delivery. Implantation of the Clareon IOL took, on average, slightly longer than that of the Vivinex IOL, mostly due to a slower IOL unfolding. The AutonoMe showed less nozzle tip damage than that of the iSert.