Long-term effectiveness and safety of a three-piece acrylic hydrophobic intraocular lens modified with hydroxyethyl-methacrylate: an open-label, 3-year follow-up study

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Abstract

Background

Clareon ^® is a new hydrophobic acrylic optic biomaterial designed for enhanced clarity and greater resistance to glistening. The present study evaluated the effectiveness and safety of a three-piece hydrophobic, monofocal intraocular lens (IOL) Model MA60NM, made of this new optic material.

Methods

In this prospective, multicenter, open-label study, eligible patients aged ≥60 years, underwent a unilateral implantation with IOL Model MA60NM following phacoemulsification. Patients were followed-up for up to 3 years after implantation. Visual outcome and serious adverse events (SAEs, cumulative and persistent) were compared to ISO grid rates (BS EN ISO 11979-7:2006). The primary effectiveness variable was Best Spectacle-Corrected Visual Acuity (BSCVA) at 1-year postoperative follow-up. In addition, posterior capsular opacification (PCO) was assessed qualitatively and graded by slit lamp exam on a 5-point scale at all visits.

Results

Overall, 179 and 138 patients completed the 1-year and 3-year postoperative follow-up, respectively. The BSCVA outcomes were better with IOL Model MA60NM than the ISO grid rates with 95.5% of patients at 1 year and 94.2% of patients at 3 years having achieved a BSCVA of 20/40 or better vs 92.5% in ISO grid. The incidence of cumulative or persistent SAEs was lower after Model MA60NM implantation than the ISO grid reference. The incidence of clinically significant PCO was 1.1% at the 1-year and 2.2% at the 3-year visit. Posterior capsulotomy rate was 1.1% at 1 year and 1.4% at 3 years.

Conclusion

The three-piece hydrophobic, monofocal IOL Model MA60NM was effective for the visual correction of aphakia and successfully met all the safety parameters as defined by the ISO criteria. PCO and posterior capsulotomy rates were low over the 3-year follow-up period. This study provides evidence and supports the long-term safety and effectiveness of the new optic biomaterial Clareon ^®.

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Most cited references 34

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Posterior capsular opacification: a problem reduced but not yet eradicated.

Suqin Guo, NIRANJAN AWASTHI, B. Wagner (2009)

Posterior capsular opacification (PCO) is the most frequent complication of cataract surgery. Advances in surgical techniques, intraocular lens materials, and designs have reduced the PCO rate, but it is still a significant problem. The only effective treatment for PCO, Nd:YAG laser capsulotomy carries vision-related complications and risks and puts a significant financial burden on the health care system. This review contains current knowledge about the mechanisms of PCO development. Posterior capsular opacification is caused mainly by remnant lens epithelial cell proliferation and migration, epithelial-mesenchymal transition, collagen deposition, and lens fiber generation. All of these processes are influenced by cytokines, growth factors, and extracellular matrix proteins. We also describe advances and improvements in surgical techniques, intraocular lens materials, and the designs and use of therapeutic agents leading to safe, effective, and less expensive strategies to eradicate PCO.

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Posterior capsule opacification.

D J Apple, K Solomon, M R Tetz … (2015)

A complication of extracapsular cataract extraction with or without posterior chamber intraocular lens (PC-IOL) implantation is posterior capsule opacification. This condition is usually secondary to a proliferation and migration of residual lens epithelial cells. Opacification may be reduced by atraumatic surgery and thorough cortical clean-up. Clinical, pathological and experimental studies have shown that use of hydrodissection, the continuous curvilinear capsulorhexis and specific IOL designs may help reduce the incidence of this complication. Capsular-fixated, one-piece all-polymethylmethacrylate PC-IOLs with a C-shaped loop configuration and a posterior convexity of the optic are effective. Polymethylmethacrylate loops that retain "memory" create a symmetric, radial stretch on the posterior capsule after in-the-bag placement, leading to a more complete contact between the posterior surface of the IOL optic and the taut capsule. This may help form a barrier against central migration of epithelial cells into the visual axis. Various pharmacological and immunological methods are being investigated but conclusive data on these modalities are not yet available.

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Eradication of posterior capsule opacification: documentation of a marked decrease in Nd:YAG laser posterior capsulotomy rates noted in an analysis of 5416 pseudophakic human eyes obtained postmortem.

G Auffarth, Q Peng, Rima D Apple … (2001)

(1) To report the neodymium:yttrium-aluminum-garnet (Nd:YAG) laser posterior capsulotomy rate (%) of eight rigid and foldable intraocular lens (IOL) designs in a series of 5416 pseudophakic human eyes obtained postmortem, accessioned in our center between January 1988 and January 2000. (2) To identify factors that are instrumental in reducing the incidence of posterior capsule opacification, (PCO, secondary cataract) and hence the need for Nd:YAG laser posterior capsulotomy. Comparative autopsy tissue analysis. A total of 5416 globes with posterior chamber intraocular lens (PC-IOLs) obtained postmortem received from Lions Eye Banks between 1988 and 2000. Miyake-Apple posterior photographic technique. Special reference was given to the presence or absence of Nd:YAG laser posterior capsulotomy orifice on the posterior capsule of each eye. The Nd:YAG laser posterior capsulotomy rate (%) as of January 2000 was documented. In addition, the Nd:YAG laser posterior capsulotomy rate for each lens was plotted on a monthly basis for the same period, creating a computerized trend or "timeline" for each IOL style. Relatively high Nd:YAG laser posterior capsulotomy rates ranging from 20.3% to 33.4% were noted with four relatively older designs (high incidence of implantation between 1988 and the early 1990s). Four modern foldable IOLs manufactured from silicone and acrylic materials had significantly lower Nd:YAG laser posterior capsulotomy rates ranging from 0.9% (Alcon Acrysof) to 17.1%. The difference in Nd:YAG rates among the eight IOL designs was found to be significant (P < 0.0001, chi-square test). Comparing foldable versus rigid designs, the foldable IOLs were associated with a much lower Nd:YAG laser posterior capsulotomy rate (14.1% vs. 31.1%). By use of the six factors regarding surgical technique and IOL choice described in this article, we strongly believe that the overall incidence of PCO and hence the incidence of Nd:YAG laser posterior capsulotomy is now rapidly decreasing from rates as high as 50% in the 1980s to early 1990s. Surgical tools and IOLs are now available to bring these rates down to single digits. Careful application and use of these tools by surgeons can genuinely lead in the direction of virtual eradication of secondary cataract, the second most common cause of visual loss worldwide.

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Author and article information

Journal

Journal ID (nlm-ta): Clin Ophthalmol

Journal ID (iso-abbrev): Clin Ophthalmol

Journal ID (publisher-id): Clinical Ophthalmology

Title: Clinical Ophthalmology (Auckland, N.Z.)

Publisher: Dove Medical Press

ISSN (Print): 1177-5467

ISSN (Electronic): 1177-5483

Publication date Collection: 2018

Publication date (Electronic): 11 October 2018

Volume: 12

Pages: 2031-2037

Affiliations

[1 ]California Eye Institute, Fresno, CA, USA, amaxwellmd@ 123456gmail.com

[2 ]Alcon Laboratories Inc., Fort Worth, TX, USA

Author notes

Correspondence: Andrew Maxwell, California Eye Institute, 1360 E Herndon Ave, Fresno, CA 93720, USA, Tel +1 559 449 5010, Email amaxwellmd@ 123456gmail.com

Article

Publisher ID: opth-12-2031

DOI: 10.2147/OPTH.S175060

PMC ID: 6188169

PubMed ID: 30349186

SO-VID: 4e1d2613-6b20-42fa-837b-cb464eca357f

License:

The full terms of this license are available at https://www.dovepress.com/terms.php and incorporate the Creative Commons Attribution – Non Commercial (unported, v3.0) License ( http://creativecommons.org/licenses/by-nc/3.0/). By accessing the work you hereby accept the Terms. Non-commercial uses of the work are permitted without any further permission from Dove Medical Press Limited, provided the work is properly attributed.

Long-term effectiveness and safety of a three-piece acrylic hydrophobic intraocular lens modified with hydroxyethyl-methacrylate: an open-label, 3-year follow-up study

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Abstract

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Karger: Ophthalmology

Most cited references 34

Posterior capsular opacification: a problem reduced but not yet eradicated.

Posterior capsule opacification.

Eradication of posterior capsule opacification: documentation of a marked decrease in Nd:YAG laser posterior capsulotomy rates noted in an analysis of 5416 pseudophakic human eyes obtained postmortem.

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