Single-piece Hydrophobic Acrylic Intraocular Lens Research Articles

Posterior capsule opacification with two similar-design hydrophobic acrylic intraocular lenses: 3-year results of a randomized controlled trial.

To compare intraindividually the incidence and intensity of posterior capsule opacification (PCO) and Nd:YAG capsulotomy rates between two similar open-loop single-piece hydrophobic acrylic intraocular lenses (IOLs) differing slightly in their particular material, optic surface and sharp posterior edge design over a period of 3 years. Department of Opthalmology, Medical University Vienna. Randomized, prospective, patient- and examiner-masked clinical trial with intraindividual comparison. 100 patients randomly received a Vivinex XY1 IOL in one eye and a Clareon CNA0T0 IOL in the fellow eye. The amount of PCO (score: 0 - 10) was assessed subjectively and objectively with digital retroillumination picturs using automated image analysis software (AQUA). Best-corrected distance visual acuity (CDVA) as well as the presence of glistenings, subjective visual symptoms and Nd:YAG laser capsulotomy rate were noted. 67 of 100 patients were available for the 3-years follow-up examination. The objective PCO score of the Vivinex XY1 IOLs was 1.0 ± 1.0 compared to the PCO score of 1.5 ± 1.2 for the Clareon CNA0T0 IOLs (p < 0.001). 7.5% of patients had a neodymium:yttrium-aluminium-garnet (Nd:YAG) capsulotomy in the Vivinex XY1 eye, and 9.0% had a capsulotomy in the Clareon CNA0T0 eye (p = 1.0). Both hydrophobic acrylic IOLs showed low PCO and YAG rates with a small but significant favor of the Vivinex XY1 IOL compared to the Clareon CNA0T0 IOL. The interaction of various factors such as hydrophobic material, smooth optic surface and sharp posterior optic edge is the major key for PCO prevention.

Late spontaneous posterior capsule rupture with single-piece hydrophobic acrylic intraocular lens dislocation

In this study, we described and discussed the late onset spontaneous posterior capsule rupture with intraocular lens (IOL) dislocation years after uncomplicated cataract surgery and implantation of hydrophobic acrylic IOLs. Eight patients presented with spontaneous posterior capsule rupture and IOL dislocation 5–20 years after uncomplicated phacoemulsification and IOL (AcrySof, Alcon, US) implantation. None of the patients had undergone posterior capsulotomy in the past. Four of the patients admitted habitual eye rubbing. An intact and well-centered continuous curvilinear capsulotomy edge was observed in all cases. IOLs were dislocated or displaced behind the anterior capsulotomy with a significant decrease in vision. A large rupture with a curled edge of the broken posterior capsule was visible. Dislocated IOLs were removed, and a three-piece IOL was inserted in the sulcus in six cases and suture fixated to the sclera in two cases. Improved vision was achieved in all cases. Although the mechanism underlying this late complication is unclear, habitual eye rubbing or IOL design may play a role. Further investigation is needed to prevent this complication in the future.

Opacification in a Preloaded Intraocular Lens

A 64-year-old woman underwent uneventful cataract surgery with implantation of enVista IOL (Bausch + Lomb) preloaded single-piece hydrophobic acrylic intraocular lens (IOL) MX60PL (Fig A). At 1-day postoperatively, a central diagonal opacity of unknown origin was observed (Fig B). After replacement of the lens, significant marks were observed on the lens under standard microscopy (Fig C). After IOL-exchange surgery, the visual acuity improved from 20/30 to 20/20. The original lens was sent to a forensic laboratory for evaluation.

Outcomes of a multicenter U.S. clinical trial of a new monofocal single-piece hydrophobic acrylic IOL.

To evaluate the safety and effectiveness of the CT LUCIA 611P intraocular lens (IOL) in patients with cataracts. 23 surgeons at 15 different clinical sites. Prospective single-arm clinical trial. The study was conducted under an Investigational Device Exemption for premarket approval of a new hydrophobic acrylic IOL in the United States. Patients were followed for 12 months, and the main measured variables included uncorrected (UDVA) and corrected (CDVA) distance visual acuities, manifest refraction, and adverse events. In total, 339 eyes of 339 patients were implanted with the study device, of which 310 (91.4%) reached the 12-month visit. The percentage of eyes within ±0.50 diopter (D) and ±1.00 D of emmetropia was 85.8% (266/310) and 96.8% (300/310), respectively. Manifest refraction spherical equivalent (MRSE) remained stable over the first year with the mean 12-month MRSE of -0.03 ± 0.45 D. The mean 12-month UDVA and CDVA were 0.09 ± 0.15 (≈20/25) and -0.02 ± 0.09 (≈20/19) logMAR, respectively. Of all patients, 99.4% (308/310) achieved postoperative CDVA ≥20/40. The incidence of Nd:YAG capsulotomy within the first year was 3.5% (11/310). Only 2 eyes had IOL tilt present at the 12-month postoperative visit with no associated visual symptoms. There were 2 cases of IOL decentration; one required removal of the IOL, whereas the other had no visual side effects related to decentration. There were no findings of glistening at any visit. The CT LUCIA 611P IOL demonstrated excellent safety, efficacy, and stability of refractive outcomes. No significant issues related to the biocompatibility of the IOL material were observed.

Clinical and histopathological findings in the dead bag syndrome.

To describe the findings of a recently described syndrome, the dead bag syndrome, in which the capsular bag appears to be clear many years postoperatively, becoming diaphanous and floppy and unable to support the intraocular lens (IOL) within it. John A. Moran Eye Center, University of Utah, Salt Lake City, Utah. Case series with clinicopathological correlation. Of 10 cases suspected to represent a dead bag syndrome, 8 IOLs and 7 capsular bags were removed because of subluxation or dislocation. The 7 capsular bags available for analysis were fixed in formalin and submitted to histopathological examination (hematoxylin-eosin and Masson trichrome stains). The associated explanted IOLs in 5 cases were also examined microscopically. Histopathologic examination of the 7 capsular bags showed capsular thinning and/or splitting. Lens epithelial cells (LECs) were completely absent on 2 specimens, whereas the other 5 specimens had rare LECs on the inner surface of the capsule. Explanted IOLs were 3-piece silicone IOLs or single-piece hydrophobic acrylic IOLs. 1 IOL optic showed a small amount of granular pigment deposition, but the optics of the other 4 IOLs were unremarkable. In this syndrome, there seems to be an absence of secondary proliferation of LECs and fibrotic changes. The capsule shows some signs of degradation, such as thinning and/or splitting. Weakness of zonular attachments seems to be an associated finding, with subsequent in-the-bag IOL dislocation. Further studies are necessary to ascertain the etiology of this condition.

Rotational Stability of a New Hydrophobic Acrylic IOL With Modified C-loop Haptics.

To assess rotational stability, axial stability, decentration, and tilt of the Rayner RAO800C single-piece hydrophobic acrylic intraocular lens (IOL) (Rayner Intraocular Lenses Ltd) from end of surgery to 4 to 7 months postoperatively. Surgeries were performed at the Department of Ophthalmology at the Medical University of Vienna. A total of 130 eyes of 68 patients received an aspheric hydrophobic Rayner RAO0800C IOL. IOLs were randomly implanted to the 0 ± 10, 45 ± 10, 90 ± 10, or 135 ± 10 degree axis. Baseline measurement was performed with the patient still supine on the operating table. Axis alignment after 1 hour, 1 week, 1 month, and 4 months was evaluated by retroillumination pictures. Postoperative IOL decentration, tilt, and aqueous depth at 4 months were assessed using an anterior segment swept-source optical coherence tomography. Absolute median IOL rotation from end of surgery to 4 months was 2.4 degrees (range: 0.0 to 85.0 degrees). Median IOL rotation from end of surgery to 1 hour, 1 hour to 1 week, 1 week to 1 month, and 1 month to 4 months was 1.6 (range: 0.0 to 86.2), 1.1 (range: 0.0 to 28.8), 0.6 (range: 0.0 to 5.2), and 0.7 (range: 0.0 to 2.6) degrees. Respective proportions of IOLs rotating more than 5, 10, and 20 degrees from end of surgery to 4 months were 23.9%, 11.0%, and 6.4%. Horizontal and vertical decentration at 4 months was -0.09 ± 0.14 and 0.09 ± 0.14 mm, respectively. Horizontal and vertical tilt at 4 months was -4.78 ± 1.36 and -1.58 ± 1.10 degrees, respectively. A posterior axial shift of 0.052 ± 0.055 mm was observed from 1 week to 4 months. Although median IOL rotation appeared to be low, a significant proportion of IOLs rotated postoperatively. Decentration and tilt values were generally low. A minimal posterior optic shift was observed after 1 week. [J Refract Surg. 2021;37(2):112-118.].

Refractive stability of a new single-piece hydrophobic acrylic intraocular lens and corneal wound repair after implantation using a new automated intraocular lens delivery system

PurposeTo investigate refractive stability and characterize corneal incision repair up to 3 months after implantation of a new hydrophobic acrylic intraocular lens (IOL) with hydroxyethylmethacrylate using a new automated IOL delivery system.MethodsThis prospective case series included 50 eyes of 50 patients undergoing phacoemulsification and implantation of the Clareon® CNA0T0 IOL using the AutonoMe® automated delivery system in the Department of Ophthalmology, Keio University School of Medicine. The clinical data were collected from 46 eyes of 46 patients preoperatively and 1 day, 1 week, and 1 and 3 months postoperatively. Endothelial-side incision gaping, posterior incision retraction, and Descemet’s membrane detachment were recorded as present or absent using anterior-segment optical coherence tomography postoperatively.ResultsThe uncorrected distance and corrected distance visual acuities improved and stabilized 1 week postoperatively. The anterior chamber depth was stable from 1 week postoperatively. The subjective refraction was stable from 1 day postoperatively. Descemet’s membrane detachments and endothelial-side wound gaping were seen in 19 (41.3%) eyes and 34 (73.9%) eyes 1 day postoperatively and decreased gradually. Posterior incision retraction was seen in eight eyes (17.4%) on day 1 and increased to 19 eyes (41.3%) 3 months postoperatively.ConclusionsThe Clareon IOL had excellent refractive stability from day 1 postoperatively. The AutonoMe automated delivery system enables safe IOL implantation through a 2.4-mm corneal incision, although the wound required longer than 1 month to heal postoperatively.

Posterior Capsule Opacification With Two Hydrophobic Acrylic Intraocular Lenses: 3-Year Results of a Randomized Trial

To compare the incidence and intensity of posterior capsule opacification (PCO) and neodymium-yttrium-aluminum-garnet (Nd:YAG) capsulotomy rates between 2 similar open-loop single-piece hydrophobic acrylic intraocular lenses (IOLs) that differ in the proprietary material characteristics and design features, over a period of 3 years. Randomized, prospective, patient- and examiner-masked clinical trial with intraindividual comparison. Setting: Department of Ophthalmology, Medical University of Vienna, Vienna, Austria. Eighty patients (160 eyes) had bilateral cataract surgery and received a Vivinex XY1 IOL in 1 eye and an AcrySof SN60WF IOL in the other eye. Follow-up examinations were performed 3 years after surgery. Digital retroillumination images were taken of each eye. The amount of PCO (score: 0-10) was assessed subjectively at the slit lamp and objectively using automated image analysis software (AQUA). PCO score (scale, 0-10). The mean objective PCO score of the Vivinex XY1 IOLs was 0.9 ± 0.8 compared to the PCO score of 1.4 ± 1.1 for the AcrySof SN60WF IOLs (P < .001). Three years postoperatively, 11.4% of patients had an Nd:YAG capsulotomy in the Vivinex XY1 eye and 18.6% had a capsulotomy in the AcrySof SN60WF eye (P= .23). The new hydrophobic acrylic Vivinex XY1 IOL showed significantly lower PCO rates and lower YAG rates compared to the AcrySof SN60WF IOL. The interaction of various factors such as hydrophobic material, smooth optic surface, and sharp posterior optic edge plays a key role in PCO development.

Surface properties of commercially available hydrophobic acrylic intraocular lenses: Comparative study

To analyze and compare the surface properties of commercially available hydrophobic acrylic intraocular lenses (IOLs). Eye Clinic, University of Trieste, Italy. Experimental study. The following 6 single-piece hydrophobic acrylic IOL models with the same dioptric power were studied and compared: Clareon SY60WF, Tecnis PCB00, enVista MX60, CT Lucia 601P, Vivinex iSert XY1, and iSert 251. Topography of the IOL surface was analyzed using atomic force microscopy (AFM). Surface contact angle measurements using the sessile drop method were performed to assess IOL wettability. The AFM analysis showed that the Vivinex iSert XY1 IOL and Clareon SY60WF IOL had the lowest surface roughness (P<.05); there was no statistically significant difference in surface roughness between the those 2 IOL models (P>.05). Surface contact angle measurements showed that the iSert 251 IOL had the highest hydrophobicity. The CT Lucia 601P IOLhad the lowest contact angle of all IOL models. The AFM analysis and surface contact angle measurements of all IOLs tested showed that the Vivinex iSert XY1 IOL and Clareon SY60WF IOL had the best topographic features. The smoother, more regular surface of these new IOL models might reduce cell adhesion and therefore lower the incidence of posterior capsule opacification.

Endophthalmitis after cataract surgery: Effect of behind-the-lens washout

To analyze the outcomes of cataract surgery with emphasis on the relationship between surgery-related factors and the incidence of postoperative infectious endophthalmitis. Ninety-three surgical sites in Japan. Prospective case series. Eyes that were scheduled to have cataract surgery from January 20 to September 30, 2014, were included. Phacoemulsification and implantation of a single-piece hydrophobic acrylic foldable intraocular lens (IOL) were performed. Patients were followed for 2months. Of the 9720 eyes enrolled, 9100 (93.6%) completed a 2-month follow-up. Three cases (0.033%) developed infectious endophthalmitis (95% confidence interval [CI], 0.000-0.070). The incidence of endophthalmitis was significantly associated with theremoval method of ophthalmic viscosurgical devices (OVDs) after IOL implantation. The incidences of endophthalmitis in cases withand without the behind-the-lens technique were 0% (0/6147; 95% CI, 0%) and 0.084% (3/3570; 95% CI, 0.000-0.179), respectively, with a significant difference between them (P=.050, Fisher exact test). The incidence of infectious endophthalmitis did not correlate with any other patient-related and surgery-related factors. The behind-the-lens technique to wash and clear the capsular bag for OVD removal significantly reduced the incidence of infectious endophthalmitis.

Two single-piece acrylic intraocular lens choices and their effect on patient-reported driving habits

To determine whether intraocular lens (IOL) type affects patient driving habits 6months to 5years after cataract surgery, and to determine whether there were differences in self-reported driving habits between patients who received 1 of 2 IOLs. John A. Moran Eye Center, University of Utah, Salt Lake City, Utah, USA. Retrospective case series. Patients completed a telephone-administered Driving Habits Questionnaire (DHQ) 6months to 5years afterhaving bilateral cataract surgery with a single-piece hydrophobic acrylic IOL, SN60WF (Group 1) or ZCB00 IOL (Group 2), in both eyes. The study comprised 260 patients (130 in each IOL group). Of these, 117 in Group 1 and 114 in Group 2 were still active drivers. The DHQ response differences for each IOL group did not reach statistical significance, except for self-rated quality of driving and difficulties with driving at night. Forthese significant differences, contradictory results were found. Patients with either of the monofocal IOLs had similar self-reported driving habits after bilateral cataract surgery. The choice of IOL did not affect patients' postoperative driving habits.

A Prospective Evaluation of Posterior Capsule Opacification in Eyes With Posterior Capsule Plaque-A Case-Control Study.

To compare the development of posterior capsule opacification (PCO) between eyes with and without posterior capsule plaque after single-piece hydrophobic acrylic intraocular lens (IOL) implantation 5 years postoperatively. A prospective observational case-control study. One hundred one consecutive eyes with posterior capsule plaque (cases) were compared with the same number of cataractous eyes without posterior capsule plaque (controls). A detailed preoperative evaluation was done to detect the presence of posterior capsule plaque. Histomorphology of posterior capsule plaque was evaluated. Postoperatively, digital retroillumination photographic documentation was performed at 1 month and 1, 2, 3, and 5 years and analyzed for PCO using the Evaluation of Posterior Capsule Opacification (EPCO) software; EPCO scores and areas were calculated. The development of PCO and the influence of the anterior capsule cover (total and partial) on the IOL optic were compared. Posterior capsule plaque on histomorphology showed a large amount of collagenous, fibrous extracellular matrix, and immunofluorescence staining was positive for alpha smooth muscle actin. In the development of PCO, there was no difference between cases and controls at 1 month and 1, 2, 3, and 5 years. Between the 2 groups, there was no difference in the development of PCO within total cover and within partial cover of the anterior capsule on the IOL up to 5 years. The presence of posterior capsule plaque did not increase the incidence of PCO at 5 years.

Comparison of stability between a modular intraocular lens system and a single-piece hydrophobic acrylic intraocular lens

To compare the movement of a modular intraocular lens (IOL) with that of a standard single-piece hydrophobic acrylic IOL in a human cadaver eye perfusion model. Department of Ophthalmology, University of Colorado, Aurora, Colorado, USA. Experimental study. Eight phakic human donor eyes of 4 patients had standard phacoemulsification with lens removal. One of 2 IOLs was then implanted in the capsular bag: a modular IOL (Harmoni) or a standard single-piece IOL (Acrysof SN60). Each globe was connected to a programmable perfusion pump with an in-line pressure transducer. Ultrasound biomicroscopy (UBM) was used to evaluate the anterior chamber depth (ACD) in each eye, measuring from the posterior cornea to the anterior surface of the optic at an intraocular pressure (IOP) of 5mm Hg, 10mm Hg, 20mm Hg, and 30mm Hg. Five consecutive measurements were recorded for all eyes at each pressure, and the results were averaged. There was significantly less movement in eyes with the modular IOL than in eyes with the single-piece IOL. The mean position of the modular IOL varied from a minimum of 0.03mm to a maximum of 0.07mm, and the mean position of the single-piece IOL varied from a minimum of 0.26mm to a maximum of 0.87mm(P=.002). The modular IOL showed less movement with changes in IOP than a standard single-piece IOL. Improved IOL stability might allow more accuracy in determining the effective lens position and hence improve the predictability of the refractive target. Proprietary or commercial disclosures are listed after the references.

Light scattering, straylight, and optical quality in hydrophobic acrylic intraocular lenses with subsurface nanoglistenings

To evaluate forward light scattering and straylight in single-piece hydrophobic acrylic intraocular lenses (IOLs) (Acrysof) removed from cadaver eyes and design- and power-matched controls, as well as the effect of subsurface nanoglistenings on other optical quality and performance indicators. John A. Moran Eye Center, University of Utah, Salt Lake City, Utah, USA. Experimental study. Seventeen single-piece IOLs (11 blue light-filtering; 6 without blue-light filter) with subsurface nanoglistenings were removed from cadaver eyes. The Complete Angle Scatter Instrument scatterometer was used to measure the forward-scattered light; straylight values at various angles were calculated. The modulation transfer function (MTF) and Badal images were also obtained. Backscatter was measured with a Scheimpflug camera (EAS-1000) and light transmittance with a spectrophotometer (Lambda 35 UV-VIS) to confirm findings in previous studies. The mean straylight values at a scattered angle of 10 degrees were 1.06 ± 0.23 log(s) for blue light-filtering IOLs, 0.97 ± 0.28 log(s) for IOLs without a blue-light filter, and 0.22 ± 0.22 log(s) for controls. The MTF and Badal image contrast of IOLs removed from cadaver eyes were similar to control values (no subsurface nanoglistenings). Backscatter was significantly higher in IOLs from cadaver eyes, although light transmittance was similar to that of controls. Straylight in hydrophobic IOLs resulting from subsurface nanoglistenings was well below the value of straylight hindrance and would not cause noticeable visual impairments. Dr. Das is an employee of Alcon Laboratories, Inc. The Complete Angle Instrument scatterometer was developed by Dr. Stover at the Scatterworks, Inc. Neither of the other authors has a financial or proprietary interest in any method or material mentioned.

A novel technique to release sticking haptic of a single-piece hydrophobic acrylic IOL using irrigation-aspiration probe.

To describe a novel technique to release sticking haptic of a single-piece hydrophobic acrylic intraocular lens (IOL) using irrigation-aspiration (I/A) probe. In our technique, the I/A probe is introduced into the anterior chamber on Visco mode. Using the aspiration port of the I/A probe, the sticking haptic is held at its tip and suction force is built up until occlusion is noted. Then the haptic is nudged towards the center of the IOL along its curve. After the haptic is free from optic, the suction is released. Several techniques have been described to release the sticking haptic such as squeezing the haptic at the site where it sticks to the IOL or using Sinskey hook for releasing the adhesion. These techniques require extra manipulation of the IOL by introduction of surgical instruments. In our technique, we used the I/A probe itself for separating the sticky haptic successfully. This technique allows separation of sticking haptic without any extra instrumentation, thus reducing intraocular maneuvering and total surgery time.

The Effect of Single-Piece Hydrophobic Acrylic Intraocular Lenses on the Development of Posterior Capsule Opacification

To evaluate the long-term effect of a single-piece hydrophobic acrylic intraocular lens (IOL), AcrySof SN60AT (Alcon Laboratories, Fort Worth, Texas, USA), on the development of posterior capsule opacification (PCO) 5 years postoperatively. Prospective, observational, consecutive, case series. setting: Iladevi Cataract and IOL Research Center, Ahmedabad, India. Three hundred and ninety eyes with uncomplicated age-related cataract were included. Patients with diabetes mellitus, glaucoma, high myopia, pseudoexfoliation, traumatic cataract, subluxated cataract, previous ocular surgeries, and allergy to dilating drops were excluded. intervention procedures: Digital retroillumination photographic documentation was performed and analyzed for PCO using Evaluation of Posterior Capsule Opacification software. The scores and areas were calculated. PCO development and the influence of the anterior capsule cover (total on and part on) on the IOL optic was studied within the capsulorrhexis margin and the central 3.0mm optic area. There was a significant increase in PCO up to 3 years. No significant change in PCO was observed between 3 and 5 years within the capsulorrhexis margin and central 3.0mm optic area. In the total on group, within the capsulorrhexis margin, significantly lower scores and areas were observed when compared with part-on scores and areas. The increase in PCO up to 3 years was significant. Stabilization in PCO was observed between 3 and 5 years with no difference at 5 years. There was a low incidence of PCO in eyes with total anterior capsule cover over the IOL optic.

Intraindividual comparative analysis of capsule opacification after implantation of 2 single-piece hydrophobic acrylic intraocular lenses models: Three-year follow-up

To compare the 3-year postoperative anterior (ACO) and posterior (PCO) capsule opacification and the level of anterior capsule retraction after implantation of 2 single-piece hydrophobic acrylic intraocular lens (IOL) models. Hospital of St. John of God, Vienna, Austria. Comparative randomized controlled double-blind clinical trial. Eyes with bilateral cataract were evaluated. Each patient had an Acrysof SA60AT (interrupted optic edge) IOL implanted in 1 eye (Group A) and a Tecnis ZCB00 (continuous optic edge) IOL implanted in the fellow eye (Group B). One and 3 years postoperatively, PCO was evaluated using Evaluation of Posterior Capsule Opacification software and the ACO level and capsule-retraction level were evaluated and graded subjectively. The study evaluated 100 eyes of 50 patients ranging from 61 to 80 years. Postoperatively, there were no statistically significant differences in PCO between Group A and Group B at 1 year (0.06 ± 0.12 [SD] and 0.07 ± 0.13, respectively; P = 4.35) or 3 years (0.23 ± 0.36 and 0.22 ± 0.32, respectively; P = .66). In Group A and Group B, ACO was present in 18.0% of eyes and 2.7% of eyes, respectively, at 1 year (P = .03) and in 92.0% and 24.0%, respectively, at 3 years (P < .01). Capsule phimosis (18.0% at 1 year; 30.0% at 3 years) and glistenings (66.0% at 1 year; 86.0% at 3 years) were observed in Group A only. Both IOLs had similarly low PCO rates 3 years postoperatively, although more ACO and capsule retraction were observed in eyes with the interrupted optic edge IOL.

Evaluation of uveal and capsule biocompatibility of a single-piece hydrophobic acrylic intraocular lens with ultraviolet–ozone treatment on the posterior surface

To evaluate a single-piece hydrophobic acrylic intraocular lens (IOL) with ultraviolet-ozone (UV-O3) treatment on the posterior surface and compare it with an identical untreated IOL in a rabbit model. John A. Moran Eye Center, University of Utah, Salt Lake City, Utah, USA. Experimental study. Study IOLs were implanted in the right eyes and control IOLs in the left eyes of 10 New Zealand rabbits. Slitlamp examinations were performed 1 to 6 weeks postoperatively. Neodymium:YAG (Nd:YAG) posterior capsulotomy was performed in both eyes of 5 rabbits after the 4-week slitlamp examination. At 6 weeks, the rabbits were killed humanely and their globes were enucleated. Capsular bag opacification was scored from the posterior aspect (Miyake-Apple view), and the eyes were processed for histopathology. At 4 weeks, the mean posterior capsule opacification (PCO) scores were 0.88 ± 0.33 (SD) in the study eyes and 2.55 ± 1.13 in the control eyes (P=.003, 2-tailed paired t test). Performance of Nd:YAG posterior capsulotomy was similar in both groups. Gross postmortem examination also showed statistically less peripheral PCO in eyes with the study IOLs than in control eyes. There was no difference in histopathologic findings between study eyes and control eyes and no signs of untoward inflammation or toxicity in any eye evaluated. Treatment of the posterior surface of a single-piece hydrophobic acrylic IOL with UV-O3 appears to prevent PCO, likely by increasing adhesion between the posterior capsule and the IOL while retaining uveal biocompatibility. Performance of Nd:YAG posterior capsulotomy was similar between treated IOLs and untreated IOLs.

A prospective evaluation of posterior capsule opacification in eyes with diabetes mellitus: a case–control study

To compare the development of posterior capsule opacification (PCO) between eyes with and without diabetes mellitus after single-piece hydrophobic acrylic intraocular lens implantation 4 years postoperatively. In this prospective, observational case-control study carried out at Iladevi Cataract and IOL Research Centre, Ahmedabad, India, 75 consecutive eyes with diabetes mellitus (cases) were compared with 75 age-matched eyes with age-related cataract (controls). A detailed, preoperative and posterior segment evaluation was carried out in eyes with diabetes mellitus to detect the presence or absence of diabetic retinopathy (DR). The Mann-Whitney U-test was applied to compare the differences in the development of PCO between the two groups. There was no difference in median PCO between cases and controls at 1 month (2.0 vs 1.50, P<0.068), but cases had a higher median PCO at 12 months (2.95 vs 1.30, P<0.001). At 4 years, there was no significant difference in median PCO between cases and controls (3.75 vs 2.25, P=0.273). The duration of diabetes increased the incidence of PCO at 4 years (P=0.02). Severity of DR had no influence on the progress of PCO at 4 years (P=0.69). Diabetes mellitus did not increase the incidence of PCO at 4 years. The duration of diabetes increased the risk of PCO. The severity of retinopathy did not influence the development of PCO.

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

PurposeTo 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 methodsThis 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.ResultsIn 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.ConclusionThis 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.