Round-edged Intraocular Lenses Research Articles

How does sharp-edged intraocular lens (IOL) design compare with round-edged IOL for preventing posterior capsule opacification after cataract surgery?

How does sharp-edged intraocular lens (IOL) design compare with round-edged IOL for preventing posterior capsule opacification after cataract surgery?

Intraocular lens optic edge design for the prevention of posterior capsule opacification after cataract surgery.

Intraocular lens optic edge design for the prevention of posterior capsule opacification after cataract surgery.

Epidemiological evaluation of YAG capsulotomy incidence for posterior capsule opacification in various intraocular lenses in Japanese eyes.

Background and objectiveWe investigated the yttrium aluminum garnet (YAG) capsulotomy rates in various intraocular lenses (IOLs).Study design/patients and methodsWe retrospectively analyzed 23,440 eyes implanted with either MA60BM, MA60AC, VA-60BB, CeeOnEdge, Clariflex, Technis Z9002, SI-40NB, or UV26T IOLs. We calculated the YAG capsulotomy rates at 1, 3, 5, and 10 years post lens implantation.ResultsYAG capsulotomy rates at 3 years postimplantation for the eight groups of IOLs were, respectively, 3.7%, 3.9%, 23.7%, 3.4%, 4.5%, 4.7%, 10.4%, and 21.0%. YAG capsulotomy rates at 10 years postimplantation for the MA60BM and SI-40NB IOLs were, respectively, 9.1% and 15% (P<0.05). The average YAG rates for all sharp-edged and round-edged IOLs at 5 years postimplantation were, respectively, 5.2%±0.7% and 25.6%±9.0% (P<0.05).ConclusionIn all studied IOLs, posterior capsule opacification prevention seemed to be associated with the posterior optic sharp-edge design. Round-edged silicone IOLs may also retard posterior capsule opacification formation, though not as much as sharp-edged IOLs. As the follow-up period progressed, round-edged silicone IOLs showed significantly higher YAG rates than sharp-edged IOLs.

Pathology of 157 human cadaver eyes with round-edged or modern square-edged silicone intraocular lenses: Analyses of capsule bag opacification

To assess the degree of capsular bag opacification in human cadaver eyes with silicone intraocular lenses (IOLs), specifically comparing the differences between round-edged IOLs and modern square-edged IOLs. John A. Moran Eye Center, University of Utah, USA. Experimental study. The eyes were immersed in 10% formalin on enucleation. They had anterior segment scanning with a very-high-frequency ultrasound (Artemis). After the eyes were sectioned at the equator, gross examination of the anterior segment was performed from the posterior aspect to assess the degree of capsular bag opacification, coverage of the IOL edge by the anterior capsule, and IOL fixation. Selected eyes also had histopathologic examination. Eighty-seven eyes with a 3-piece round-edged IOL, 43 with a 3-piece square-edged IOL, 26 with a 1-piece plate IOL, and 1 with an accommodating IOL design were included in the analyses of capsular bag opacification. Comparison between 3-piece round-edged IOLs and square-edged IOLs showed statistically significant differences in central posterior capsule opacification (PCO) (P=.0001687) and peripheral PCO (P<.0001). In eyes with square-edged IOLs, PCO had a tendency to start in areas without capsulorhexis coverage of the optic. Twenty-one of 26 eyes with a silicone plate IOL had a neodymium:YAG posterior capsulotomy for dense PCO. This first study using pseudophakic human cadaver eyes that includes a significant number of modern 3-piece silicone IOLs with square optic edges confirmed the role of this design in the prevention of PCO. No author has a financial or proprietary interest in any material or method mentioned.

Interventions for preventing posterior capsule opacification.

Posterior capsule opacification (PCO) remains the most common long-term complication after cataract surgery. It can be treated by Nd:YAG laser capsulotomy, however this may lead to other complications and laser treatment is not available in large parts of the developing world. Therefore, many studies try to find factors influencing the development of PCO. To summarise the effects of different interventions to inhibit PCO. These include modifications of surgical technique and intraocular lens (IOL) design, implantation of additional devices and pharmacological interventions. We searched CENTRAL, MEDLINE, EMBASE, LILACS in March 2009 and reference lists of identified trial reports. We included only prospective, randomised and controlled trials with a follow-up time of at least 12 months. Interventions included modifications in surgical technique explicitly to inhibit PCO, modifications in IOL design (material and geometry), implantation of additional devices and pharmacological therapy compared to each other, placebo or standard treatment. We extracted data and entered it into RevMan. We compared visual acuity data, PCO scores and YAG capsulotomy rates and performed a meta-analysis when possible. Sixty six studies were included in the review. The review was divided into three parts. 1. Influence of IOL optic material on the development of PCO. There was no significant difference in PCO development between the different IOL materials (PMMA, hydrogel, hydrophobic acrylic, silicone) although hydrogel IOLs tend to have higher PCO scores and silicone IOLs lower PCO scores than the other materials. 2. Influence of IOL optic design on the development of PCO. There was a significantly lower PCO score (-8.65 (-10.72 to -6.59), scale 0 to 100) and YAG rate (0.19 (0.11 to 0.35)) in sharp edged than in round edged IOLs, however not between 1-piece and 3-piece IOLs. 3. Influence of surgical technique and drugs on the development of PCO. There was no significant difference between different types of intraoperative/postoperative anti-inflammatory treatment except for treatment with an immunotoxin (MDX-A) which led to a significantly lower PCO rate. Due to the highly significant difference between round and sharp edged IOL optics, IOLs with sharp (posterior) optic edges should be preferred. There is no clear difference between optic materials. The choice of postoperative anti-inflammatory treatment does not seem to influence PCO development.

Effect of intraocular lens design on posterior capsule opacification

Posterior capsule opacification (PCO) remains the most common long-term complication after cataract surgery. Many studies have attempted to identify factors that influence the development of PCO. The aim of this systematic review based on Cochrane methodology was to summarize the effects of intraocular lens (IOL) geometry, including modifications of the IOL optic (especially optic edge design) and haptics, on the development of PCO. Twenty-six prospective randomized controlled trials with a follow-up of at least 12 months were included. In 5 of 7 studies, visual acuity was better in sharp-edged IOLs than in round-edged IOL. The PCO score was significantly lower with sharp-edged IOLs but did not differ significantly between 1-piece and 3-piece open-loop IOLs. Because of the significant difference in the PCO score, sharp-edged IOL optics should be preferred to round-edged IOL optics.

Statistical problems caused by missing data resulting from neodymium:YAG laser capsulotomies in long-term posterior capsule opacification studies: Problem identification and possible solutions

To describe a way to eliminate the problem caused by missing data due to neodymium:YAG (Nd:YAG) laser capsulotomies before statistical analysis, which leads to incomplete data in long-term studies of posterior capsule opacification (PCO). Medical University of Vienna, Vienna, Austria. To demonstrate the problem, an existing long-term study comparing PCO development in eyes with round-edged and sharp-edged intraocular lenses (IOLs) was analyzed. In the study, several Nd:YAG capsulotomies led to dropouts in the round-edged IOL group. To solve the resulting missing value problem, the missing values were replaced by estimated PCO values in various scenarios; that is, different assumptions were made of how PCO would have developed without a capsulotomy. Standard statistical analyses that included the estimated PCO values rather than excluding the incomplete cases were then performed. The analysis of all cases (including the estimated PCO scores) showed a highly significant difference between the round-edged group and the sharp-edged group. Sensitivity analyses confirmed that the difference between the 2 groups remained significant up to highly implausible values chosen for the missing PCO scores, thus proving the correctness of the analysis. This study showed it is possible to perform statistical analyses without excluding incomplete cases. This approach is recommended for all studies with Nd:YAG dropouts as it increases the statistical power. Excluding incomplete cases may lead to biased or wrong study conclusions.

Effect of square-edged intraocular lenses on neodymium:YAG laser capsulotomy rates in the United States

To model the effect of the introduction of square-edged intraocular lenses (IOLs) in the United States on neodymium:YAG (Nd:YAG) laser capsulotomy rates and to compare the model with actual capsulotomy rates. Ophthalmology Department, St. Thomas' Hospital, London, United Kingdom, and Cullen Eye Institute, Baylor College of Medicine, Houston, Texas, USA. The actual numbers of cataract surgeries and Nd:YAG laser capsulotomies performed in the U.S. were obtained from Medicare claims data for 1993 to 2003. The percentage market share of square-edged IOLs was obtained, and numbers of square-edged and round-edged IOLs implanted were calculated. Predicted laser capsulotomy rates were modeled on published postmortem and clinical data and compared with actual capsulotomy rates. Between 1993 and 2003, the number of cataract surgeries and Nd:YAG laser capsulotomies reimbursed by Medicare rose by 67.4% and 18.9%, respectively. After the introduction of square-edged IOLs in 1995, the market share grew to 48.5% in 2003. The total number of Nd:YAG capsulotomies reimbursed by Medicare in 2003 exceeded the number of capsulotomies predicted by the model by at least 23.9%. The estimated cost generated by the discrepancy between predicted and actual laser capsulotomies in 2003 was at least US $30 million. After the introduction of square-edged IOLs, Nd:YAG laser capsulotomy rates decreased, but not by as much as predicted. The additional cost to the Medicare system was more than US $30 million higher than the model predicted.

Effect of intraocular lens edge profile on posterior capsule opacification after extracapsular cataract surgery in a developing country

To determine whether square-edged polymethyl methacrylate (PMMA) intraocular lenses (IOLs) reduce posterior capsule opacification (PCO) in the context of extracapsular cataract surgery in a developing country. A rural hospital in India. This was a prospective randomized double-masked fellow-eye controlled study. Over a 4-month period, 118 patients with normal eyes apart from age-related cataract were randomized to receive a square-edged or round-edged PMMA IOL in the first eye. The IOLs were identical apart from the edge profile. The fellow-eye had implantation of the alternative IOL within 1 month. Retroillumination images of the posterior capsule were taken using a dedicated camera system and analyzed to quantify the PCO area using POCO software 1 and 2 years postoperatively and the PCO area and severity using POCOman semiqualitative software at 2 years. Visual acuity was measured using a Gujarati logMAR chart. One hundred fifteen patients were available for examination at 1 year and 107 at 2 years. With POCO software, the PCO area was reduced in the square-edged IOL group at 1 year (median 30% versus 20%, P=.001) and at 2 years (median 45% versus 35%, P=.006). With POCOman, the PCO area and severity were reduced in the square-edged group at 2 years (median 41.5% versus 33.2%, P=.019 and 0.59 versus 0.46, P=.037, respectively). There was no significant difference in visual acuity between the 2 groups at 1 or 2 years. Sophisticated image analysis techniques can be used in developing countries to quantify PCO. Using extracapsular surgery, square-edged PMMA IOLs reduced the PCO area and severity compared with an identical round-edged IOL; however, the differences were not as marked as those reported with phacoemulsification. This may be due to the difficulty of performing a capsulorhexis that lies on the IOL surface in this situation. Nevertheless, square-edged IOLs offer a potential benefit for extracapsular surgery in the developing world.

Contact inhibition of migrating lens epithelial cells at the capsular bend created by a sharp-edged intraocular lens after cataract surgery

To investigate whether the lens epithelial cells (LECs) at the capsular bend created by a sharp-edged intraocular lens (IOL) are in the G(0) phase of the cell cycle. Nishi Eye Hospital, Osaka, Japan. A CeeOn Edge silicone IOL (AMO) with sharp edges was implanted in 1 eye and a PhacoFlex II silicone IOL (AMO) with rounded edges in the contralateral eye after standard cataract surgery in 6 rabbits. Immunohistochemical staining for the Ki-67 antibody was performed 1 day, 3, 4, and 7 weeks after surgery. In eyes with the sharp-edged IOL, LECs with thin, elongated nuclei accumulated at, but did not extend beyond, the capsular bend and stained negative for the Ki-67 antibody, indicating that they were in the G(0) phase of the cell cycle. In contrast, in the eye with the round-edged IOL, continuous migration of a predominantly monolayer of LECs over the IOL and onto the posterior capsule occurred. These cells were Ki-67 positive, indicating that they were proliferating. Lens epithelial cells at the capsular bend of sharp-edged IOLs were in the G(0) phase of the cell cycle, indicating that they were contact inhibited. These findings support the theory the sharp posterior optic edge of the IOL inhibits LEC migration, reducing formation of posterior capsule opacification. Whether these LECs can reactivate when the capsular bend is eliminated by later formation of a Soemmerring's ring requires further studies.

Long-term efficacy of adding a sharp posterior optic edge to a three-piece silicone intraocular lens on capsule opacification: Five-year results of a randomized study

To compare the intensity of capsule opacification with the sharp and the round optic edge variant of an open-loop hydrophobic silicone intraocular lens (IOL). Randomized, controlled, double-blind clinical trial with intraindividual comparison. Fifty-one patients with bilateral age-related cataract were included (102 eyes). Each patient had had cataract surgery in both eyes and received a Microsil IOL with a sharp optic edge design (model S) in one eye and a Microsil IOL with a round optic edge design (model R) in the fellow eye. Both IOLs had an identical haptic design (nonangulated polymethylmethacrylate) and silicone optic material. The patients were examined at the slit lamp, best-corrected visual acuity was assessed, and standardized high-resolution digital retroillumination images of the posterior capsule were taken 5 years after surgery. The intensity of regeneratory posterior capsule opacification (rPCO), fibrotic PCO (fPCO), and anterior capsule opacification (ACO) was assessed subjectively at the slit lamp, and of rPCO, objectively using automated image analysis software (AQUA). The need for an Nd:YAG laser capsulotomy (Nd:YAG-LCT) was noted. The mean AQUA PCO score was 1.2 for the model S and 2.4 for the model R lens (P = .001). The model S lens also led to less peripheral fPCO (P = .003). Concerning ACO, there was no significant difference between both IOL groups (P = .72). Whereas no capsulotomy was required with the model S, four cases (16%) had been performed in the model R group. Five years postoperatively, the sharp-edged silicone IOL showed less rPCO and fPCO than the round-edged IOL. However, regarding ACO, there was no significant difference between both IOL styles.

In vivo digital imaging of the square-edged barrier effect of a silicone intraocular lens

To evaluate and compare by high-magnification digital photography the lens epithelial cell (LEC) response and capsule dynamics in vivo after implantation of a square-edged and a round-edged silicone intraocular lens (IOL) in a fellow-eye study. Private practice and Royal Victoria Hospital, Barrie, and Soldiers' Memorial Hospital, Orillia, Ontario, Canada. After phacoemulsification, a single surgeon implanted a square-edged silicone IOL (SoFlex SE, Bausch & Lomb) in 25 patients who had previously had a conventional round-edged version of the same IOL (SoFlex Li61U, Bausch & Lomb) implanted in their contralateral eye within a 6-week period. SoFlex SE IOL recipients were selected sequentially from those scheduled for surgery within a 3-day period. The IOLs were sequentially photographed 1 week and 1, 3, 6, and 9 months after surgery using magnification of at least x64 through a biomicroscope and a high-resolution digital camera with adapter. Images were transferred to a graphics computer and compared over time. At 1 week, both designs had evidence of LEC migration along the posterior capsule, with the highest cell density around the 6 o'clock position. At 1 month, both IOL designs showed 360 degrees of anterior and posterior capsule adhesion to the edge of the optic. At 1 month, however, migrating LECs encountered a "damming" effect at the square posterior edge but not at the round edge. A thin fibrotic ring began to form around the SoFlex SE edge at 2 months and was complete for 360 degrees at 3 months. At 9 months, there was no evidence of LEC migration beyond this ring. With round-edged IOLs, the fibrotic ring never fully formed and LEC migration continued posterior to the optic. There was a tight capsule shrink-wrap effect with the square-edged IOLs with the fibrotic ring, allowing minimal IOL movement between 1 month and 9 months. The round-edged IOLs tended to decenter and rotate. Anterior capsulorhexis contraction was greater at every time point with the round-edged IOLs than with the square-edged IOLs. Early contact inhibition of LECs by a square-edged IOL design and its effects were demonstrated in vivo with sequential, high-resolution digital photography and commercially available graphics software.

Effect of a silicone intraocular lens with a sharp posterior optic edge on posterior capsule opacification

Purpose: To compare the inhibiting effect on posterior capsule opacification (PCO) of a silicone intraocular lens (IOL) with a sharp posterior optic edge (ClariFlex OptiEdge®, Advanced Medical Optics) and a silicone IOL with a round optic edge (PhacoFlex SI-40, Advanced Medical Optics). Setting: Department of Ophthalmology, University of Vienna, Vienna, Austria. Methods: This prospective randomized patient- and examiner-masked study comprised 104 eyes of 52 patients with bilateral age-related cataract. All patients had cataract surgery in both eyes and received a sharp-edged IOL in 1 eye and a round-edged IOL in the other eye. Postoperative examinations were at 1 week, 1 and 6 months, and 1 year. Digital slitlamp and retroillumination images were taken of each eye. The amount of PCO was assessed subjectively at the slitlamp and objectively using Automated Quantification of After-Cataract (AQUA) automated-image analysis software. Results: The sharp-edged IOL group had significantly less regeneratory and fibrotic PCO 1 month, 6 months, and 1 year after surgery. The mean AQUA PCO score (scale 0 to 10) was 0.71 in the sharp-edged IOL group and 1.40 in the round-edged IOL group ( P<.001). The sharp-edged IOL group had less peripheral fibrotic PCO. There was no significant difference between the 2 IOL groups in patient reports of edge glare. Conclusion: The sharp-edged design of the ClariFlex OptiEdge silicone IOL led to significantly less PCO than the round-edged PhacoFlex SI-40 IOL 1 year postoperatively.

Computerized analysis of the effects of intraocular lens edge design on the quality of vision in pseudophakic patients

Purpose To study the distribution and intensity of reflected glare images from 3 intraocular lens (IOL) edge designs. Setting Eye Institute, University of Florence, Florence, Italy. Methods The interaction of light rays as a function of edge design was evaluated using an experimental eye model and an advanced ray-tracing program. Three hydrophobic acrylic IOLs were studied: an acrylic square-edged (sharp) design, an acrylic round-edged design, and a new acrylic IOL with a rounded anterior edge and a sharp posterior edge. Results The rays hitting the sharp edge of an IOL caused peripheral arcs or circles of light on the side of the retina opposite the focused image. Edge reflections also occurred with the round-edged IOL, but the intensity of the reflected image was one tenth that of the intensity with the sharp-edged design. The new round-/sharp-edged design reduced the maximum intensity of the reflected image to one third the intensity of the sharp-edged reflected image. Conclusions The experimental findings with an acrylic IOL that combines a sharp posterior edge with a low incidence of reflected edge glare are promising.