Comparison of posterior capsule opacification between the 1-piece and 3-piece Acrysof intraocular lenses: Two-year results of a randomized trial

doi:10.1016/j.ophtha.2004.03.028

Ophthalmology

Volume 111, Issue 10, October 2004, Pages 1840-1846

https://doi.org/10.1016/j.ophtha.2004.03.028 Get rights and content

Abstract

Purpose

To compare intensity of posterior capsule opacification (PCO) between the 1-piece and 3-piece haptic designs of an open-loop hydrophobic acrylic intraocular lens (IOL).

Design

A randomized, patient- and examiner-masked clinical trial with intraindividual comparison.

Participants

Fifty-two patients with bilateral age-related cataract (104 eyes).

Methods

Each patient had cataract surgery in both eyes and received a 1-piece Acrysof IOL in one eye and a 3-piece Acrysof IOL in the fellow eye. Follow-up examinations were at 1 week, 1 month, 6 months, 1 year, and 2 years. Patients were examined at the slit lamp, visual acuity (VA) was determined, and standardized high-resolution digital retroillumination images of the posterior capsule were taken. The intensity of PCO was assessed subjectively at the slit lamp and objectively using automated image analysis software.

Main outcome measure

Posterior capsule opacification score (scale, 0–10).

Results

There was no significant difference between IOL styles in best-corrected VA, rhexis/IOL overlap, capsular folds, and amount of anterior capsule opacification during the follow-up period. One year postoperatively, the amount of regeneratory PCO was higher for the 1-piece Acrysof eyes (image analysis software score: 1.3) than for the 3-piece Acrysof eyes (score: 0.9; P = 0.002). However, 2 years postoperatively, there was no significant difference between the 2 IOL styles (1-piece: 1.5; 3-piece: 1.3; P = 0.3). Neodymium:yttrium–aluminum–garnet capsulotomy was not performed in the study.

Conclusion

One year postoperatively, the 1-piece Acrysof showed slightly more regeneratory PCO than the 3-piece Acrysof. However, 2 years postoperatively, the barrier effect of the 1-piece design was comparable to that of the 3-piece haptic design, with low PCO intensity.

Section snippets

Patient recruitment

Fifty-two patients (104 eyes) were included in this randomized, patient- and examiner-masked clinical trial with intraindividual comparison. The study was performed at the Department of Ophthalmology at the Vienna General Hospital (Medical University Vienna). The patients were recruited from a continuous cohort. Inclusion criteria were bilateral age-related cataract and good overall physical constitution. Exclusion criteria were a history of other ocular diseases or intraocular surgery, laser

Results

The age of the study patients was 74.0±10.7 years (mean ± standard deviation [SD]). Three patients were excluded postoperatively because they were not operated bilaterally. Fifteen patients were not available for follow-up examination (1 patient died before the 1-year follow-up, 1 patient died before the 2-year follow-up, and 13 patients could not be reached). Of the 52 patients included in the study, 34 (22 SA30/MA30, 12 SA60/MA60) were available for all follow-up examinations.

Posterior

Discussion

The results of the present study demonstrate that the modification of the IOL haptic design of an acrylic IOL with a sharp optic edge from a 3-piece haptic design to a 1-piece haptic design caused no significant change in PCO at 2 years.

The sharp optic edge of the Acrysof IOL was originally a result of the manufacturing process. The knowledge of its effect on LEC migration was rather coincidental. Further studies confirmed that the rectangular shape of the IOL optic edge was in fact the major

References (29)

R.R. Holweger et al.
Intraocular pressure change after neodymiumYAG capsulotomy
J Cataract Refract Surg
(1997)
T.J. Newland et al.
Experimental neodymiumYAG laser damage to acrylic, poly(methyl methacrylate), and silicone intraocular lens materials
J Cataract Refract Surg
(1999)
R.F. Steinert et al.
Cystoid macular edema, retinal detachment, and glaucoma after NdYAG laser posterior capsulotomy
Am J Ophthalmol
(1991)
L. Rickman-Barger et al.
Retinal detachment after neodymiumYAG laser posterior capsulotomy
Am J Ophthalmol
(1989)
J. Ram et al.
Update on fixation of rigid and foldable posterior chamber intraocular lenses. Part IIchoosing the correct haptic fixation and intraocular lens design to help eradicate posterior capsule opacification
Ophthalmology
(1999)
O. Nishi
Posterior capsule opacification. Part 1experimental investigations
J Cataract Refract Surg
(1999)
M.F. Ellis
Sharp-edged intraocular lens design as a cause of permanent glare
J Cataract Refract Surg
(2001)
J.T. Holladay et al.
Analysis of edge glare phenomena in intraocular lens edge designs
J Cataract Refract Surg
(1999)
R. Tester et al.
Dysphotopsia in phakic and pseudophakic patientsincidence and relation to intraocular lens type
J Cataract Refract Surg
(2000)
M.V. Pande et al.
High-resolution digital retroillumination imaging of the posterior capsule after cataract surgery
J Cataract Refract Surg
(1997)

W. Buehl et al.

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

J Cataract Refract Surg

(2002)

S. Sacu et al.

Assessment of anterior capsule opacificationphotographic technique and quantification

J Cataract Refract Surg

(2002)

O. Findl et al.

Comparison of 4 methods for quantifying posterior capsule opacification

J Cataract Refract Surg

(2003)

Q. Peng et al.

Surgical prevention of posterior capsule opacification. Part 3intraocular lens optic barrier effect as a second line of defense

J Cataract Refract Surg

(2000)

Cited by (45)

Pediatric Cataract Surgery: Rate of Secondary Visual Axis Opacification Depending on Intraocular Lens Type
2022, Ophthalmology
Citation Excerpt :
Although the overall rate of VAO was similar for all models (23%–25%), MA60 recipients aged > 3 months had less VAO than those receiving single-piece IOLs (10% vs. 16%–23%). In adults, randomized trials have shown increased early posterior capsule opacification in the SA models26 but similar outcomes on longer follow-up.26,27 Overall, it seems that the high proliferation rates in infancy25 and in surgeries without posterior capsule management28 eclipse any differences in IOL design.
To assess the time course of secondary visual axis opacification (VAO) leading to additional surgery after primary intraocular lens (IOL) implantation in children and to describe further surgical outcomes. Comparison of lens types.
Single-center, retrospective analysis of children aged 1 to 14 years who underwent cataract surgery with primary IOL implantation. The surgical technique was either in-bag IOL placement with primary posterior capsulotomy and anterior vitrectomy or bag-in-lens IOL placement. We excluded eyes with visually significant ocular comorbidities.
Total of 135 eyes of 95 children. Of these, 64 had received an acrylic 3-piece IOL, 51 had an acrylic single-piece IOL, and 20 had an acrylic single-piece bag-in-lens IOL. The median ages at surgery were 53 months (interquartile range [IQR], 35–75), 52 months (27–65), and 60 months (40–84) in the 3-piece, 1-piece, and bag-in-lens groups, respectively.
Analysis of medical records. We used the Kaplan–Meier method and a Cox proportional hazards model with predefined adjustments for age at surgery, year of surgery, and the German Index of Socioeconomic Deprivation (score by postal code) to analyze VAO-free survival by lens type. Patients were invited to attend a clinical visit to achieve longer follow-ups.
The rate of survival without VAO that required clearing of the visual axis after cataract surgery with primary IOL implantation. Any other surgical complications.
The overall median follow-up was 19 months (IQR, 3–58). There were 13 cases of VAO, occurring at a median of 10 months (IQR, 10–12) after surgery. Of these, 1 eye had a 3-piece in-bag IOL, 10 eyes had 1-piece in-bag IOLs, and 2 eyes had bag-in-lens IOLs. The adjusted hazard ratio was 32.8 (95% confidence interval [CI], 3.3–327, P = 0.003) for 1-piece acrylic IOLs and 19.6 (CI, 1.22–316, P = 0.036) for bag-in-lens IOLs, compared with 3-piece acrylic in-bag IOLs. Two eyes with bag-in-lens surgery (10%) had an iris capture. There was 1 case of endophthalmitis. We found no cases of postoperative retinal detachment or new glaucoma.
Children with secondary VAO who required a procedure to clear the visual axis generally presented within 15 months. Opacification rates were lowest when a 3-piece acrylic IOL was used.
Five-Year Cumulative Incidence and Risk Factors of Nd:YAG Capsulotomy in 10 044 Hydrophobic Acrylic 1-Piece and 3-Piece Intraocular Lenses
2019, American Journal of Ophthalmology
Citation Excerpt :
A Cochrane meta-analysis of 66 prospective randomized controlled trials assessing the effect of different interventions on PCO found no difference between 1- and 3-piece IOLs.5 Nevertheless, some studies have reported higher risk of PCO or Nd:YAG capsulotomy associated with 1-piece design.11–13 The thin haptics of 3-piece IOLs may enable a more uniform fusion between the anterior and posterior capsules.
To evaluate the 5-year cumulative incidence and risk factors of Nd:YAG capsulotomy between hydrophobic acrylic intraocular lenses (IOLs).
A retrospective cohort study.
A review of the registry of operations between the years 2007 and 2016 was carried out at the Ophthalmology Unit of Kymenlaakso Central Hospital, Kotka, Finland. A total of 10 044 eyes having cataract surgery and in-the-bag implantation of ZCB00 (Abbott Medical Optics Johnson & Johnson Vision, Inc, Abbott Park, Illinois, USA), SN60WF (Alcon Laboratories, Inc, Fort Worth, Texas, USA), or ZA9003 (Abbott Medical Optics Johnson & Johnson Vision, Inc) IOLs were included in the study. The cumulative incidence of Nd:YAG capsulotomy was estimated with competing risks methodology. Competing risks regression modeling was used to evaluate potential risk factors, including the patient's age, sex, type of IOL, dioptric power of IOL, and operating surgeon's seniority.
The 5-year cumulative incidence of Nd:YAG capsulotomy after cataract surgery was 13.2% (95% confidence interval [CI] 12.5%-14.0%) for all eyes and 18.1% (16.5%-20.0%), 11.5% (10.5%-12.6%), and 9.6% (8.2%-11.4%) for ZCB00, SN60WF, and ZA9003 IOLs, respectively. Implantation of SN60WF and ZA9003 IOLs was associated with a 38% and 47% subhazard reduction (SHR), respectively, compared to ZCB00, after accounting for other predictors (SHR = 0.62; 95% CI 0.54-0.71; P < .001 and SHR = 0.53; 95% CI 0.43-0.64; P < .001). Increased risk of Nd:YAG capsulotomy was associated with eyes of patients aged younger than 60 years, female sex, and eyes implanted with an IOL of <22.5 diopters power.
Real-world evidence suggests that the cumulative incidence of Nd:YAG capsulotomy is significantly lower in eyes receiving SN60WF or ZA9003 IOLs compared to ZCB00.
The effect of single-piece hydrophobic acrylic intraocular lenses on the development of posterior capsule opacification
2015, American Journal of Ophthalmology
Citation Excerpt :
These IOLs also showed significantly higher Nd:YAG capsulotomy rates as compared to other IOLs. With the introduction of the single-piece hydrophobic acrylic IOL design, the effect of this modification on PCO development has become a subject of debate in the literature.20–23 According to the Evaluation of Posterior Capsule Opacification convention, only eyes with intact posterior capsules should be included in the assessment.
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. study population: 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. main outcome measures: 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 3.0 mm 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 3.0 mm 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.
Posterior capsule opacification
2014, Journal Francais d'Ophtalmologie
L’opacification capsulaire postérieure constitue la complication la plus commune de la chirurgie de la cataracte. Elle atteint en moyenne un patient sur trois. Elle tend à être considérée comme un évènement normal dans l’histoire naturelle des cataractes opérées. Une meilleure compréhension de sa physiopathogénie a permis d’en réduire son incidence. L’amélioration de la technique chirurgicale de phakoexérèse mais aussi du design et du biomatériau de la lentille intra-oculaire y ont largement contribué. Son traitement reste un geste rapide et non invasif. Néanmoins, avec le recul, l’ouverture de la capsule postérieure au laser Nd : YAG peut engendrer également de nombreuses complications. Le meilleur traitement reste donc préventif.
Posterior capsule opacification (PCO) is the most common complication after cataract surgery, with an incidence of 30%. It tends to be considered a normal event in the natural history of cataract surgery. Better understanding of its pathophysiology and advancement of intraocular lens material and design along with the improvement of phacoemulsification technique have contributed to decrease the incidence of PCO. Although treatment by Nd: YAG laser posterior capsulotomy is quick and non-invasive, the opening of the posterior capsule may be associated with numerous complications. Prevention remains the best measure for controlling this pathology.
Posterior capsule opacification and neodymium:YAG rates with 2 single-piece hydrophobic acrylic intraocular lenses: Three-year results
2013, Journal of Cataract and Refractive Surgery
To compare the incidence and intensity of posterior capsule opacification (PCO) between 2 similar 1-piece foldable hydrophobic acrylic intraocular lenses (IOLs) over 3 years.
Department of Ophthalmology, Medical University Vienna, Vienna, Austria.
Randomized prospective patient- and examiner-masked clinical trial with intraindividual comparison.
Patients with bilateral age-related cataract had cataract surgery and implantation of a Tecnis ZCB00 continuous-optic-edge IOL in 1 eye and an Acrysof SA60AT interrupted-optic-edge IOL in the other eye. Postoperative examinations were performed at 6 months and 3 years. Digital retroillumination images were taken of each eye. The amount of PCO (score 0 to 10) was assessed subjectively at the slitlamp and objectively using automated image-analysis software.
The study comprised 54 patients (108 eyes). The mean objective PCO score was 1.3 ± 1.7 (SD) for the continuous-optic-edge IOLs and 0.9 ± 1.3 for the interrupted-optic-edge IOLs (P=.10). Three years postoperatively, a neodymium:YAG (Nd:YAG) capsulotomy was performed in 26.1% of eyes with the continuous-optic-edge IOL and 21.7% with the interrupted-optic-edge IOL (P=.56). There was no significant difference in corrected distance visual acuity, capsulorhexis–IOL overlap, capsule folds, or anterior capsule opacification 3 years after surgery.
Both IOLs had comparable PCO and Nd:YAG rates 3 years postoperatively. The optimized barrier function of the continuous-optic-edge IOL and the material properties of the interrupted-optic-edge IOL seemingly outbalanced the effect on lens epithelial cell migration and proliferation beneath the optic.
No author has a financial or proprietary interest in any material or method mentioned.
Comparison of clinical efficacy: Nd:YAG laser rates after implantation of AcrySof® SN60WF, Akreos® AO-MI60 and Hoya® YA-60BB
2013, Journal Francais d'Ophtalmologie
To compare Nd:YAG laser rates following implantation of AcrySof^® SN60WF (Alcon), Akreos^® AO-MI60 (Baush & Lomb), and Hoya^® YA-60BB (Hoya) intraocular lenses.
This retrospective study was conducted at three French centers with each implanting at least two of the three implants. Included patients had undergone uncomplicated cataract surgery with at least 3 years of follow-up. Records of patients implanted with one of the three IOL's were drawn randomly from the surgical logs. Postoperative data were obtained from the medical records of either the surgeon or the referring physician. Time elapsing until Nd:YAG laser was analysed using Kaplan-Meier survival curves.
Three hundred eyes were implanted (AcrySof^® 126, Akreos^® 89, and Hoya^® 85). AcrySof^® recipients were the youngest (AcrySof^® 72.1, Akreos^® 76.4, and Hoya^® 75.2 years of age: P = 0.0007). The sex ratio was 4:6 male:female. Follow-up was longest for Hoya eyes (AcrySof^® 29.4, Akreos^® 24.6 and Hoya^® 34.6 months; P = 0.0002). Eyes implanted with AcrySof^® had 1.74 times less chance of Nd:YAG laser treatment than Hoya eyes (P = 0.0327) and 3.50 times less than Akreos^® eyes (P < 0.0001). The results remained unchanged when the analysis was restricted to events in the first 24 months (Risk Ratios: Hoya^® = 2.64: P = 0.02; and Akreos^® = 4.22: P = 0.0001). Adjustment on unbalanced confounding variables did not alter the results.
Eyes with AcrySof^® implants required significantly fewer Nd:YAG laser capsulotomies than those with Hoya^® and Akreos^® implants and were therefore less subject to Nd:YAG laser treatment complications, thus ensuring better vision at the lowest cost.
Comparer le taux de Nd:YAG laser d’AcrySof^® SN-60WF (Alcon), Akreos^® AO-MI60 (Baush&Lomb) et Hoya^® YA-60BB (Hoya).
Il s’agit d’une étude rétrospective conduite sur 3 sites français. Chaque centre implantait au moins deux des trois implants. Les patients avaient eu une chirurgie de la cataracte sans complication et au moins trois ans de suivi. Les patients implantés avec l’une des trois lentilles ont été tirés au sort à partir du registre opératoire. Les données étaient collectées à partir des dossiers patients. Les données postopératoires provenaient des fichiers du chirurgien ou de ceux du médecin référent. Le temps jusqu’au laser était analysé avec des courbes de survie de Kaplan Meyer.
Cent vingt-six yeux ont été implantés avec AcrySof^®, 89 avec Akreos^® et 85 avec Hoya^®. Les patients AcrySof^® étaient plus jeunes (72,1, 76,4 et 75,2 ; p = 0,0007, respectivement). Le sex-ratio était de quatre hommes:six femmes. Le suivi était plus long avec Hoya^® (29,4, 24,6, et 34,6 mois, respectivement). Les yeux avec AcrySof^® avaient 1,74 fois moins de chance d’avoir un Nd:YAG laser qu’avec Hoya^® et 3,50 fois moins qu’avec Akreos^® (p < 0,0001). Les résultats étaient inchangés quand l’analyse est restreinte à 24 mois (Hazard ratios : Hoya^® = 2,64 : p = 0,02 ; and Akreos^® = 4,22 : p = 0,0001). Les ajustements ne changeaient pas les résultats.
Les yeux implantés avec AcrySof^® avaient significativement moins de capsulotomies par Nd:YAG laser que ceux implantés avec Hoya^® et Akreos^®. Avec AcrySof^®, les yeux sont moins exposés aux complications du Nd:YAG laser, garantissant une meilleure vision à moindre coût.

View all citing articles on Scopus

^☆

Manuscript no. 230886.

The authors have no financial or proprietary interest in any of the materials or equipment mentioned in this article.

View full text

Original articleComparison of posterior capsule opacification between the 1-piece and 3-piece Acrysof intraocular lenses: Two-year results of a randomized trial☆

Abstract

Purpose

Design

Participants

Methods

Main outcome measure

Results

Conclusion

Section snippets

Patient recruitment

Results

Discussion

J Cataract Refract Surg

J Cataract Refract Surg

Am J Ophthalmol

Am J Ophthalmol

Ophthalmology

J Cataract Refract Surg

J Cataract Refract Surg

J Cataract Refract Surg

J Cataract Refract Surg

J Cataract Refract Surg

J Cataract Refract Surg

J Cataract Refract Surg

J Cataract Refract Surg

J Cataract Refract Surg

Original article
Comparison of posterior capsule opacification between the 1-piece and 3-piece Acrysof intraocular lenses: Two-year results of a randomized trial☆