3D monitoring of the microphase separations inside the intraocular lens.

Glistenings often occur after implanting the intraocular lens (IOL) due to the formation of numerous microvacuoles (MVs) and may lead to deterioration of vision quality. Previous studies showed the formation of MVs was associated with the hydrophobicity of IOL materials. Yet, the mechanism remains an open question due to the complexity of IOL polymer networks. In this study, two commercialized IOLs with similar hydrophobicity are found distinct in the formation of MVs. The 3D growth kinetics of MVs during cooling processes are captured for the first time by digital holographic microscopy (DHM) and the components of MVs are measured by DHM and Raman spectroscopy. The results reveal that the growth of MVs stems from the microphase separation of water and surrounding IOL polymers. A polymer swelling model is thus proposed to describe the microphase separation process which is found dependent on the elasticity of IOL polymer networks. The total volume of MVs is determined by the IOL hydrophobicity, while the elastic force of IOL polymer networks determines the number density and size of MVs. This study demonstrates an approach for characterizing the phase separation of crosslinked polymeric materials in biosystems and sheds lights on the refinement of IOL materials. STATEMENT OF SIGNIFICANCE: Glistenings due to the formation of numerous microvacuoles (MVs) in intraocular lens (IOL) can occur after IOL implantation, which may induce poor quality of vision. However, the underlying mechanism of MVs formation is still an open question. This study establishes an in-situ 3D imaging platform to monitor growth kinetics of the MVs in IOLs, which allows to uncover the mechanism of glistenings formation resulting from the microphase separation. The findings imply the material hydrophobicity influences the total volume of MVs, while the local elasticity of IOL polymer networks determines the number density and the size of MVs. This study offers a new approach for characterizing phase separation in crosslinking biosystems and sheds lights on the refinement of IOL materials.

In-vitro assessment of a novel intraocular lens made of crosslinked polyisobutylene.

PURPOSE: To describe and analyse the particularities of the material and the optical quality of the first intraocular lens (IOL) (Eyedeal® lens) made of crosslinked polyisobutylene (xPIB). METHODS: We assessed the material quality using an accelerated ageing process (to provoke glistenings) and compared values with a control, AcrySof® lens. Using the sessile drop method, the contact angle of the new IOL was measured. Images of the lens surface were recorded by scanning electron microscopy (SEM). Optical quality was assessed by measuring the labeled power and modulation transfer function (MTF) using standard metrology equipment (OptiSpheric IOL PRO2). RESULTS: The Eyedeal® lens had an average glistening density result of 7.46 ± 3.78 MV/mm2 compared to the control AcrySof® whose glistenings number was 142.42 ± 72.47 MV/mm2. The contact angle was 97.2° whereas the angle of AcrySof material is between 73.3 ± 2.4° and 84.4 ± 0.1°. Using SEM, Eyedeal® lenses were examined and all appeared to be comparable to modern IOLs made of acrylic materials. The power and MTF values were normal and conformed to ISO standards. CONCLUSIONS: In the laboratory, the new Eyedeal® lens showed equivalence to current hydrophobic- or hydrophilic-acrylic lens models. It showed superiority in its glistening density result compared to the control lens.

Clinical Evaluation of a Hydrophobic Intraocular Lens Using a Preloaded Automated Injector in a Korean Population.

Purpose: This study assessed post-market clinical outcomes of the Clareon monofocal intraocular lens (IOL) preloaded in the AutonoMe Delivery System in a real-world setting of Korean patients. Methods: This prospective, multicenter, single-arm study in Korea was conducted from July 2020 to December 2021. Patients were ≥20 years old with unilateral or bilateral cataracts who received Clareon IOLs (CNA0T0) preloaded in an automated injector system. Best corrected distance visual acuity (BCDVA) and uncorrected distance visual acuity (UCDVA) were evaluated under photopic conditions. Surgeon delivery system preference was assessed using a survey questionnaire. Glistenings, surface haze, adverse events, posterior capsule opacification (PCO), and Nd:YAG capsulotomy rates were also assessed during the 12-month postoperative follow-up. Results: Mean ± SD monocular BCDVA was 0.02 ± 0.11 and 0.00 ± 0.10 logMAR at 1 month and 12 months, respectively. BCDVA of 0.2 logMAR or better was achieved by 94.4% and 99.1% of eyes at 1 month and 12 months after implantation, respectively. Mean monocular UCDVA was 0.11 ± 0.14 and 0.07 ± 0.13 logMAR at 1 month and 12 months, respectively. UCDVA of 0.3 logMAR or better was achieved by 97.4% of eyes at 12 months after implantation. Preparation of the automated injector system was rated as "very easy" or "easy" and CNA0T0 IOL delivery was rated as "very controllable" or "controllable" by all surgeons. Only grade 0 glistenings and no surface haze were observed during the 12-month follow-up. No clinically significant PCO or Nd:YAG capsulotomy were reported throughout the study; clinically nonsignificant PCO was reported in 23% of eyes. Conclusion: This 12-month real-world study of the CNA0T0 IOL and the automated injector system demonstrated excellent visual outcomes and high surgeon satisfaction.

A new software for automated counting of glistenings in intraocular lenses in vivo.

AIM: To assess the performance of a bespoke software for automated counting of intraocular lens (IOL) glistenings in slit-lamp images. METHODS: IOL glistenings from slit-lamp-derived digital images were counted manually and automatically by the bespoke software. The images of one randomly selected eye from each of 34 participants were used as a training set to determine the threshold setting that gave the best agreement between manual and automatic grading. A second set of 63 images, selected using randomised stratified sampling from 290 images, were used for software validation. The images were obtained using a previously described protocol. Software-derived automated glistenings counts were compared to manual counts produced by three ophthalmologists. RESULTS: A threshold value of 140 was determined that minimised the total deviation in the number of glistenings for the 34 images in the training set. Using this threshold value, only slight agreement was found between automated software counts and manual expert counts for the validating set of 63 images (κ=0.104, 95%CI, 0.040-0.168). Ten images (15.9%) had glistenings counts that agreed between the software and manual counting. There were 49 images (77.8%) where the software overestimated the number of glistenings. CONCLUSION: The low levels of agreement show between an initial release of software used to automatically count glistenings in in vivo slit-lamp images and manual counting indicates that this is a non-trivial application. Iterative improvement involving a dialogue between software developers and experienced ophthalmologists is required to optimise agreement. The results suggest that validation of software is necessary for studies involving semi-automatic evaluation of glistenings.

Twelve-Months Follow-Up Postmarket Study of a Hydrophobic Intraocular Lens Using a Preloaded Automated Injector in an Indian Population.

Purpose: To assess real-world clinical outcomes and safety of the Clareon® intraocular lens (IOL) and AutonoMe® automated preloaded delivery system in an Indian population. Patients and methods: This was a prospective, single-arm, multicenter, 12-month clinical study in patients aged ≥20 years with unilateral or bilateral cataracts. Surgery was performed by phacoemulsification followed by implantation of the Clareon monofocal IOL (CNA0T0). Monocular best-corrected distance visual acuity (BCDVA) and uncorrected distance visual acuity (UCDVA) were assessed at 1 week and 1, 6, and 12 months after implantation. Posterior capsular opacification (PCO), surface haze, and glistenings were evaluated at all visits. Surgeons' satisfaction with automated injector system was also evaluated using a questionnaire. Safety was assessed by monitoring adverse events (AEs). Results: A total of 151 eyes received the CNA0T0 IOL. Mean ± SD monocular BCDVA improved from 0.53±0.44 logMAR preoperatively to 0.00±0.08 logMAR at week 1 and -0.03±0.08 logMAR at 12 months after implantation. At 12 months, 137/137 (100%) of eyes achieved BCDVA of 0.3 logMAR or better. Mean ± SD monocular UCDVA was 0.78±0.40 logMAR preoperatively, 0.11±0.15 logMAR at week 1, and 0.08±0.13 logMAR at 12 months after implantation. At 12 months, 132/137 (96%) eyes achieved UCDVA of 0.3 logMAR or better. Serious intraoperative AEs were posterior capsule rupture (n=1) and ciliary zonular dehiscence (n=1). Surgeons reported that the automated preloaded device was more intuitive compared with other push- or screw-style preloaded injector systems. None of the eyes in this study presented surface haze; all were graded as 0 glistenings at all visits. No clinically significant PCO or neodymium-doped yttrium aluminum garnet (Nd:YAG) capsulotomies were reported. Conclusion: The hydrophobic IOL preloaded in an automated injector system provided good visual and refractive outcomes, as well as no surface haze and grade 0 glistenings. None of the patients required Nd:YAG capsulotomy.

Comparison Between L-312 Hydrophobic-Hydrophilic Acrylate and US-860 UV Hydrophilic Acrylate IOL Opacification Characteristic.

Objective: To compare opacity characteristics of US-860 UV and L-312 IOL, and report the phenomenon of glistenings in hydrophobic-hydrophilic acrylic IOLs. Setting: Qingdao Eye Hospital. Design: Experimental study. Methods: Four medical records (4 eyes) of patients with L-312 or US-860 UV IOL opacification reporting decreased or lost vision who underwent IOL explanation between 2019 and 2021 were reviewed. Explanted IOLs were analyzed by slit-lamp examination, confocal microscopy, scanning electron microscopy (SEM) and energy-dispersive X-ray spectroscopy (EDS) at Qingdao Eye Hospital and Qingdao university of science and technology. Results: The 4 explanted IOLs were represented by 2 hydrophilic acrylic designs. The preoperative mean corrected distance visual acuity changed from 1.84 ± 1.09 logarithm of the minimum angle of resolution (log MAR) to 0.20 ± 0.03 log MAR postoperatively except case 3. The mean interval of the L-312 IOL was 56.67 ± 14.19 months (range 44 to 72 months), and the interval of the US-860 UV IOL was 27 months. Morphological findings were surface, subsurface calcifications of the US-860 UV IOL material, and the optical region of L-312 IOLs are teeming with a great number of vacuoles by light microscope, scanning electron microscope and Energy Dispersive X-ray Spectral. Conclusion: The cause of US-860 UV opacification was primary calcification, and vacuoles resulted in L-312 IOL opacification.

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.

Effectiveness and Safety of the Clareon Monofocal Intraocular Lens: Outcomes from a 12-Month Single-Arm Clinical Study in a Large Sample.

PURPOSE: This study assessed effectiveness and safety of the novel Clareon intraocular lens (IOL; model SY60CL; Alcon Vision LLC). PATIENTS AND METHODS: This was a prospective, single-arm, unmasked clinical trial at 16 investigative clinical sites in the United States. Included were adults ≥22 years who required cataract extraction by phacoemulsification. Following phacoemulsification, 350 subjects received SY60CL IOL unilaterally; 342 completed the study. Monocular best corrected distance visual acuity (CDVA) and uncorrected distance visual acuity (UDVA) were evaluated. The primary effectiveness endpoint was the percentage of subjects with CDVA ≤0.3 logMAR at month 12. Safety was assessed by monitoring adverse events (AEs). Visual acuity and safety outcomes were compared with historical safety and performance endpoint (SPE) rates. RESULTS: At 12 months post-implantation, 99.7% of subjects receiving the SY60CL IOL achieved monocular CDVA ≤0.3 logMAR (primary effectiveness endpoint; 1-sided 95% upper confidence limit >SPE rate); 99.7% and 86.8% of subjects achieved monocular CDVA of ≤0.34 (20/40 Snellen or better) and ≤0.04 logMAR (20/20 Snellen or better), respectively. At 12 months, >95% of subjects achieved mean monocular UDVA ≤0.3 logMAR; 97.1% and 57.6% of subjects achieved monocular CDVA of ≤0.34 and ≤0.04 logMAR, respectively. Mean monocular CDVA and UDVA were -0.05 and 0.04 logMAR, respectively. AEs were within SPE limits. The most common nonserious ocular AE was posterior capsule opacification (5.4%). Serious AEs were <1%, and no serious ocular AEs were assessed as related to the device. There were no observations for IOL glistenings at 12 months. CONCLUSION: Results of this study supported effectiveness and safety of the SY60CL IOL. Visual acuity outcomes with the SY60CL IOL exceeded the SPE rates for monocular CDVA and AEs were within the limit of historic SPE rates. (Model number SY60WF is the Clareon lens approved by the FDA.).

Quantification of the In Vitro Predisposition to Glistening Formation in One Manufacturer's Acrylic Intraocular Lenses Made in Different Decades.

INTRODUCTION: Foldable hydrophobic acrylic intraocular lenses (IOLs) are prone to develop a long-term postoperative material change called glistenings. The aim of this study was to investigate the changes in the predisposition for glistening formation in one type of hydrophobic acrylic IOL material from its introduction to the present day. METHODS: In a laboratory setup, an in vitro model was used to induce glistenings in hydrophobic acrylic IOLs manufactured by one company (Alcon, Fort Worth, TX, USA) in different years: 23 1990s-manufacture hydrophobic acrylic three-piece IOLs (MA30BA/MA60AC) that were explanted in 1996 and 1997, and five of each of the newer AcrySof IOL models (MA60AC, SA60AT, TFNT00 and SN60WF) from 2014 to 2017. Furthermore, five Clareon (SY60WF) IOLs were put through the same accelerated aging procedure. The number of microvacuoles per square millimeter (MV/mm2) was determined in the central part of each IOL optic and compared between the groups. RESULTS: The mean number of MV was highest in the 1990s-manufacture Alcon acrylic IOLs, with 1289 (± 738) MV/mm2. The number decreased to 650 (± 101), 192 (± 105), 175 (± 112) and 47 (± 26) for MA60AC, SA60AT, TFNT00 and SN60WF, respectively. The lowest count was obtained in the Clareon group, with 1 (± 1) MV/mm2. CONCLUSIONS: A high number of glistenings was induced in the explanted IOLs from the 1990s. The propensity for glistening formation decreased considerably after that decade and now in current use. Even though in vitro glistening formation in today's AcrySof material was low, the Clareon material was essentially glistenings-free.

[Opacification of intraocular lenses: laboratory and clinical findings]. / Eintrübung von Intraokularlinsen: Erkenntnisse aus dem Labor und der Klinik.

BACKGROUND: Since their introduction the spectrum of complications of intraocular lenses (IOLs) has changed. Clouding of the IOL material is increasingly described in the literature as a reason for explantation. OBJECTIVE: This study aimed to give an overview of the various pathologies of IOL material. MATERIAL AND METHODS: The currently relevant types of IOL material opacities are summarized as well as their effects on the optical quality. RESULTS AND CONCLUSION: In current IOL models calcification can occur in lenses made of hydrophilic acrylate, while in IOLs made of hydrophobic acrylate "glistenings" can develop. These different material opacifications have varying impacts on optical quality parameters and in general lead to an increased intraocular light scattering. In the case of intolerable IOL material opacification, the only treatment option is its removal and the implantation of a new IOL.

Glistening formation in a new hydrophobic acrylic intraocular lens.

BACKGROUND: The formation of fluid-filled microvacuoles, termed glistenings, is a common complication of intraocular lenses (IOLs) made from hydrophobic acrylate. Using our well-established in-vitro laboratory method, we evaluated a new IOL material's resistance to glistening formation. METHODS: An in-vitro stress test for glistening induction was performed on 20 samples of hydrophobic acrylic IOLs: ten of the new Eyecryl ASHFY600 (Biotech Vision Care, Ahmedabad, India) compared with ten samples of AcrySof IQ SN60WF (Alcon, Fort Worth, USA). The number of microvacuoles per square millimetre (MV/mm2) was evaluated in five sections of each IOL. The results for each model were compared and rated on a modified Miyata Scale for grading glistening severity. RESULTS: In all cases, glistening number was higher in the central section of the IOL optic than in the periphery. Mean number of MV/mm2 was highest in the central part of the AcrySof IQ SN60WF, with 41.84 (±27.67) MVs/mm2. The lowest number of glistenings was found in the five sections of the Eyecryl ASHFY600 with 0.52 (±0.24) MVs/mm2. Mean value of the Eyecryl ASHFY600 IOL, using the Miyata Scale, was Zero. CONCLUSION: In this in-vitro laboratory study, the new hydrophobic acrylic IOL showed a high resistance to microvacuole formation. Results from this in-vitro study suggest that glistening numbers will be low in clinical use in the Eyecryl ASHFY600.

Effects of intraocular lens glistenings on visual function: a prospective study and presentation of a new glistenings grading methodology.

OBJECTIVE: To investigate the effect of intraocular lens (IOL) glistenings on visual performance and evaluate a new glistenings grading methodology. METHODS AND ANALYSIS: Thirty-four patients (34 eyes) were recruited. Corrected distance visual acuity (CDVA), mesopic gap acuity (MGA), functional contrast sensitivity (FCS) and forward light scatter were measured (Advanced Vision and Optometric Tests, City Occupational, London, UK). The IOL centre was imaged and glistenings density graded by three observers using the Miyata scale and a new system. Inter-rater reliability, association between the two grading scales, and correlations between glistenings grades and visual performance parameters were evaluated. RESULTS: The intraclass correlation coefficient between graders for the new grading system was 0.769 (95% Confidence Interval [CI] 0.636 to 0.868). There was a significant association between the Miyata scale and the new grading system for all graders (rs=0.533-0.895, p≤0.001). There was no association between CDVA or MGA and glistenings grade (rs=- 0.098, p=0.583 and rs=0.171, p=0.359, respectively). There was no association between FCS at mesopic light levels and glistenings grade (rs=-0.032, p=0.864), or the straylight parameter and glistenings grade (rs=0.021, p=0.916). No association was found between the integrated straylight parameter and glistenings grade (rs=0.078, p=0.701). CONCLUSION: The new glistenings grading scale was highly reproducible. In this cohort, glistenings in the same hydrophobic acrylic IOL after cataract surgery were not associated with changes in visual function, as assessed by a series of tests not previously used in glistenings research.

Polarized glasses may help in symptomatic cases of intraocular lens glistenings.

Intraocular lens (IOL) glistening is a relatively common phenomenon. Although most of the patients remain asymptomatic, a small percentage of patients can develop unwanted optical side effects. We report 6 symptomatic patients with IOL glistening. All patients underwent an implantation of a hydrophobic acrylic mononofocal, multifocal or toric IOL in external clinics for visually significant cataract at least 6 months prior. Patients had very reasonable corrected visual acuity (0.8-1.0 decimal), but significantly had reduced contrast sensitivity and modulation transfer function, complained of visual phenomena and expressed dissatisfaction with their visual status. Patients indicated the symptoms were not present immediately after surgery, but gradually developed postoperatively. Slit-lamp examination revealed moderate-to-severe glistening in all cases. No other pathology that would be responsible for the visual symptoms was present. Patients reported improvement in side effects with the use of edge filter (blue-light blocking) eyeglasses and polarized sunglasses with an increase in contrast sensitivity by aproximately 1 line on Pelli-Robson chart. The use of specific eyewear seems to be a promising alternative to avoid explant of an IOL in symptomatic patients with glistenings and very good visual acuity. In conclusion, we believe that long-term optical clarity is crucial for the choice of an IOL.

Long-term clinical results and scanning electron microscopic analysis of the aspheric, hydrophobic, acrylic intraocular lens CT LUCIA 611P(Y).

PURPOSE: The aim of this study was to evaluate the clinical outcomes of a novel designed hydrophobic, acrylic, monofocal, fully preloaded intraocular lens (IOL; CT LUCIA 611P) 1 year after implantation. Scanning electron microscopic analysis regarding the optic-haptic junction and sharp edges of the IOL was performed. PATIENTS AND METHODS: This is a noninterventional, observational prospective study of cataract patients who underwent implantation of the CT LUCIA 611P. Ninety-six eyes of 54 subjects were enrolled. Follow-up included visual acuity assessment, slit lamp examination with special focus on appearance of glistenings and evaluation of posterior capsule opacification (PCO). Scanning electron microscopic analysis of the new designed optic-haptic junction and edges of the IOL was performed. RESULTS: Best-corrected distance visual acuity increased from mean 0.48 logMAR (range 0.86-0.34) preoperatively to mean 0.02 logMAR (range 0.14 to -0.10) 1 year after surgery. Thirty-eight of 42 subjects' eyes (90.5%), which underwent bilateral surgery with implantation of the IOL, never required glasses for distance again, while 4 (9.5%) required glasses only in rare cases (eg, driving at night). The spherical equivalent was within ±0.50 D in 88 of 96 subjects (91.7%) and within ±0.75 D in 96.9% of cases. Target refraction ±1.00 D was achieved in 100% of subject eyes. No glistenings were reported in any case. From the surgeons' perspective, the wider, thicker optic-haptic transition of the IOL resulted in significantly increased stiffness, which enabled improved centering of the IOL and enhanced rotational stability and refractive predictability and stability and PCO prevention. CONCLUSION: The results of this long-term observational study demonstrate the safety and efficacy of the IOL. Because of the completely new designed thicker and stiffer optic-haptic junction regarding improved characteristics of the IOL (stability in the capsular bag), some special attention has to be addressed to the slightly different behavior of the lens during implantation and unfolding process.

Glistenings, anterior/posterior capsular opacification and incidence of Nd:YAG laser treatments with two aspheric hydrophobic acrylic intraocular lenses - a long-term intra-individual study.

PURPOSE: To compare two hydrophobic acrylic intraocular lenses (IOLs) regarding long-term anterior/posterior capsular opacification (ACO/PCO) development and need for neodymium:Yttrium-Aluminum-Garnet (Nd:YAG) laser treatment due to visually disturbing PCO, and to study development of glistenings in the IOL materials. METHODS: In a prospective, randomized, intra-individual, comparative trial, 50 cataract patients received either an AcrySof IQ® SN60WF (Alcon, Fort Worth, TX, USA) or a Tecnis® ZCB00 (Abbott Medical Optics, Santa Ana, CA, USA) IOL in the first operated eye, and the second eye received the IOL type not implanted in the first eye. Anterior/posterior capsular opacification (ACO/PCO) and fibrosis were monitored with slit-lamp photography and semi-automated digital analysis 2 and 3 years postoperatively. Glistenings were semi-quantitatively assessed in slit-lamp photographs. Nd:YAG laser treatment for visually disturbing PCO was monitored. RESULTS: Visual outcomes were similar for the two IOLs. Anterior capsular fibrosis and/or opacification developed more often in SN60WF eyes. Mean PCO area percentage was larger in ZCB00 eyes 3 years after surgery, but severity score did not differ with statistical significance between the two IOLs. Six ZCB00 eyes and 2 SN60WF eyes underwent Nd:YAG laser treatment during a mean of 4 years 8 months after surgery. This difference was not statistically significant. A high amount of glistenings developed in most SN60WF IOLs, while only few ZCB00 IOLs displayed a low degree of glistenings. CONCLUSION: Visual outcomes, PCO development over time and need for Nd:YAG laser treatment were similar for the two IOLs. Anterior capsule fibrosis/contraction and glistenings were more pronounced with the SN60WF IOL.

New Hydrophobic IOL Materials and Understanding the Science of Glistenings.

An introduction to the history of intraocular lenses (IOLs) is given, leading up to modern hydrophobic examples. The roles of hydrophobicity, hygroscopy, materials chemistry, and edge design are discussed in the context of IOLs. The four major types of IOL materials are compared in terms of their chemistry and biocompatibility. An example of a modern "hydrophobic" acrylic polymer with higher water content is discussed in detail.

Safety and effectiveness of a single-piece hydrophobic acrylic intraocular lens (enVista®) - results of a European and Asian-Pacific study.

PURPOSE: To evaluate the safety and effectiveness of a single-piece hydrophobic acrylic intraocular lens (IOL) (enVista® MX60; Bausch and Lomb Incorporated, Rochester, NY, USA) following implantation to correct aphakia subsequent to extracapsular cataract extraction in adults. SUBJECTS AND METHODS: This was an open-label, non-interventional, observational study conducted in 19 university and private-practice settings in Europe and the Asia-Pacific region to investigate clinical outcomes of the MX60 IOL in standard practice. Eligible subjects were at least 18 years of age and had undergone standard phacoemulsification and extracapsular cataract extraction with implantation of the MX60 IOL. The primary safety endpoint was the occurrence of adverse events, and the primary effectiveness endpoints included visual and refractive outcomes and stability, with data collected up to 2 years post-procedure. RESULTS: In this multicenter study, pooled data of 255 eyes were collected and analyzed. Excellent visual and refractive outcomes and stability were demonstrated. At postoperative visit 4 (61-180 days postoperative), 62.2% of subjects achieved a Snellen best-corrected distance visual acuity (CDVA) of 20/20 (decimal 1.00), and 97.8% of subjects achieved a CDVA of 20/40 (decimal 0.50) or better. One eye (1.0%) underwent neodymium:yttrium aluminum garnet capsulotomy at 12 months post-procedure. No glistenings of any grade were reported for any subject at any visit. Adverse events were infrequent and were consistent with incidences generally reported with cataract surgery. CONCLUSION: This study, which enrolled all comers, provided evidence of the excellent safety and effectiveness of the MX60 IOL in standard practice. Favorable clinical outcomes included outstanding visual and refractive outcomes and stability. No glistenings were reported at any postoperative visit.

Clinical properties of a novel, glistening-free, single-piece, hydrophobic acrylic IOL.

A new, single-piece, hydrophobic acrylic lens - the first constructed with a lens optic and haptics comprised of a hydroxyethyl methacrylate-polyethylene glycol phenyl ether acrylate-styrene copolymer, cross-linked with ethylene glycol dimethacrylate, and labeled as "glistening-free" - was recently introduced globally. Glistenings have been a significant source of clinical concern with previous hydrophobic lens designs. This new monofocal lens provides enhanced, clear optics for lens-based surgery. The superior optical clarity of this lens is achieved through the elimination of glistenings, enhanced surface durability, high refractive index, a high Abbe number, and an aspheric design. Additionally, the lens design reduces the risk of developing posterior capsule opacification.

Safety and effectiveness of a glistening-free single-piece hydrophobic acrylic intraocular lens (enVista).

PURPOSE: To evaluate the safety and effectiveness of a single-piece hydrophobic acrylic intraocular lens (IOL; enVista model MX60; Bausch & Lomb, Rochester, NY, USA) when used to correct aphakia following cataract extraction in adults. METHODS: This was a prospective case series (NCT01230060) conducted in private practices in the US. Eligible subjects were adult patients with age-related cataract amenable to treatment with standard phacoemulsification/extracapsular cataract extraction. With follow-up of 6 months, primary safety and effectiveness end points included the rates of US Food and Drug Administration (FDA)-defined cumulative and persistent adverse events and the percentage of subjects who achieved best-corrected visual acuity (BCVA) of 20/40 or better at final visit. To evaluate rotational stability, subjects were randomized (1:1:1:1) to have the lens implanted in one of four axis positions in 45° increments. RESULTS: A total of 122 subjects were enrolled. The rate of cumulative and persistent adverse events did not significantly exceed historical controls, as per FDA draft guidance. At the final postoperative visit, all subjects (100%) achieved a BCVA of 20/40 compared with the FDA historical control of 96.7%. Rotation of the IOL between the two final follow-up visits was ≤5° for 100% of eyes, and refractive stability was demonstrated. A low evaluation of posterior capsule opacification score was demonstrated, and no glistenings of any grade were reported for any subject at any visit. CONCLUSION: This study demonstrated the safety and effectiveness of the MX60 IOL. Favorable clinical outcomes included preserved BCVA, excellent rotational and refractive stability, no glistenings, and a low evaluation of posterior capsule opacification score.