Evaluation of posterior capsule opacification of the Alcon Clareon IOL vs the Alcon Acrysof IOL using a human capsular bag model

Hillenmayer, Anna; Wertheimer, Christian; Kassumeh, Stefan; Studnitz, Annabel von; Luft, Nikolaus; Ohlmann, Andreas; Priglinger, Siegfried; Mayer, Wolfgang J.

doi:10.1186/s12886-020-01349-5

Cited by 14 publications

(23 citation statements)

References 29 publications

Supporting

Mentioning

Contrasting

Order By: Relevance

“…11 A recent study using human capsular bag model reported similar PCO formation rates with AcrySof and Clareon IOLs. 25 In this study, PCO was not assessed at the end of the cataract surgery. The rate of PCO reported in this study was 5.4% (19/350), and the rate of Nd:YAG capsulotomy was 4.6% (16/350).…”

Section: Discussionmentioning

confidence: 99%

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

Lehmann¹,

Maxwell²,

Lubeck³

et al. 2021

OPTH

View full text Add to dashboard Cite

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.

show abstract

Section: Discussionmentioning

confidence: 99%

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

Lehmann¹,

Maxwell²,

Lubeck³

et al. 2021

OPTH

View full text Add to dashboard Cite

show abstract

“…The ciliary body is pinned to the ring and the capsular bag suspended over the lumen. This approach combined with improvements in culture conditions that better reflect surgical inflammation, maintains the capsular bag integrity and is ideal for studying IOLs in relation to PCO (Eldred et al, 2014;Eldred et al, 2019;Hillenmayer et al, 2020) (Figure 2).…”

Section: J O U R N a L P R E -P R O O Fmentioning

confidence: 99%

Posterior capsule opacification: What's in the bag?

Wormstone

Smith

et al. 2021

Progress in Retinal and Eye Research

120

102

View full text Add to dashboard Cite

This is a PDF file of an article that has undergone enhancements after acceptance, such as the addition of a cover page and metadata, and formatting for readability, but it is not yet the definitive version of record. This version will undergo additional copyediting, typesetting and review before it is published in its final form, but we are providing this version to give early visibility of the article. Please note that, during the production process, errors may be discovered which could affect the content, and all legal disclaimers that apply to the journal pertain.

show abstract

“…• Inhibition of molecular pathways [112,121,132,134,135] • Investigation of molecular pathways [29,136] • Investigation of intraocular lenses [108,137,138] Clinical studies n/a…”

Section: Model Type Tissue Donors Application Referencesmentioning

confidence: 99%

Factors Affecting Posterior Capsule Opacification in the Development of Intraocular Lens Materials

Cooksley

Lacey²,

Dymond

et al. 2021

Pharmaceutics

View full text Add to dashboard Cite

Posterior capsule opacification (PCO) is the most common complication arising from the corrective surgery used to treat cataract patients. PCO arises when lens epithelial cells (LEC) residing in the capsular bag post-surgery undergo hyper-proliferation and transdifferentiation into myofibroblasts, migrating from the posterior capsule over the visual axis of the newly implanted intraocular lens (IOL). The developmental pathways underlying PCO are yet to be fully understood and the current literature is contradictory regarding the impact of the recognised risk factors of PCO. The aim of this review is firstly to collate the known biochemical pathways that lead to PCO development, providing an up-to-date chronological overview from surgery to established PCO formation. Secondly, the risk factors of PCO are evaluated, focussing on the impact of IOLs’ properties. Finally, the latest experimental model designs used in PCO research are discussed to demonstrate the ongoing development of clinical PCO models, the efficacy of newly developed IOL technology, and potential therapeutic interventions. This review will contribute to current PCO literature by presenting an updated overview of the known developmental pathways of PCO, an evaluation of the impact of the risk factors underlying its development, and the latest experimental models used to investigate PCO. Furthermore, the review should provide developmental routes for research into the investigation of potential therapeutic interventions and improvements in IOL design in the aid of preventing PCO for new and existing patients.

show abstract

Evaluation of posterior capsule opacification of the Alcon Clareon IOL vs the Alcon Acrysof IOL using a human capsular bag model

Cited by 14 publications

References 29 publications

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

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

Posterior capsule opacification: What's in the bag?

Factors Affecting Posterior Capsule Opacification in the Development of Intraocular Lens Materials

Contact Info

Product

Resources

About