Intraocular Implantable Collamer Lens with a Central Hole Implantation: Safety, Efficacy, and Patient Outcomes

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Abstract

This review summarizes the available literature and provides updates on the efficacy, safety, and patient outcomes of phakic intraocular lens implantation using implantable collamer lens (ICL), with a focus on newer models with a central port (EVO/EVO+ Visian Implantable Collamer Lens, STAAR Surgical Inc.). All studies included in this review were identified from the PubMed database and were reviewed for relevancy of their topic. Data on hole-ICL implantation performed between October 2018 and October 2022 in 3399 eyes showed a weighted average efficacy index of 1.03 and a weighted average safety index of 1.19 within an average follow-up of 24.7 months. The incidence of complications such as elevated intraocular pressure, cataract, and corneal endothelial cell loss was low. Moreover, both quality of vision and quality of life improved after ICL implantation, confirming the benefits of this procedure. In conclusion, ICL implantation is a promising refractive surgery alternative to laser vision correction with excellent efficacy, safety, and patient outcomes.

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Most cited references 97

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Meta-analysis and review: effectiveness, safety, and central port design of the intraocular collamer lens

Mark Packer (2016)

The purpose of this review is to summarize relevant data from publications appearing in the peer-reviewed scientific literature over the past decade since US Food and Drug Administration approval of the implantable collamer lens (ICL), and, in particular, to review studies relating to sizing methodology, safety, and effectiveness, as well as more recent studies reporting clinical outcomes of the V4c Visian ICL with KS Aquaport, VICMO. A literature search was conducted using two databases, PubMed.gov and Science.gov, to identify all articles published after 2005 related to the Visian ICL (STAAR Surgical, Inc.). Articles were examined for their relevance to sizing methodology, clinical safety, and effectiveness, and the references cited in each article were also searched for additional relevant publications. The literature review revealed that all currently reported methods of determining the best-fit size of the ICL achieve similarly satisfactory results in terms of vault, the safe distance between the crystalline lens and the ICL. Specifically, meta-analysis demonstrated that sulcus-to-sulcus and white-to-white measurement-based sizing methods do not result in clinically meaningful nor statistically significant differences in vault (two-sample two-sided t-test using pooled mean and standard deviations; t (2,594)=1.33; P=0.18). The reported rates of complications related to vault are very low, except in two case series where additional risk factors such as higher levels of myopia and older age impacted the incidence of cataract. On the basis of preclinical studies and initial clinical reports, with up to 5 years of follow-up, the new VICMO central port design holds promise for further reduction of complications. Given its safety record and the significant improvement in vision and quality of life that the ICL makes possible, the benefits of ICL implantation outweigh the risks.

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United States Food and Drug Administration clinical trial of the Implantable Collamer Lens (ICL) for moderate to high myopia: three-year follow-up.

K Doney, Monica Poco, Robert Sanders (2004)

To report on 3-year postoperative safety and efficacy outcomes with the Myopic Implantable Collamer Lens (ICL). Prospective nonrandomized clinical trial. Five hundred twenty-six eyes of 294 patients with between 3.0 and 20.0 diopters (D) of myopia participating in the United States Food and Drug Administration clinical trial of the ICL for myopia. Implantation of the ICL. Uncorrected visual acuity (VA), refraction, best spectacle-corrected VA (BSCVA), adverse events, operative and postoperative complications, lens opacity analysis, subjective satisfaction, and patient symptoms. At 3 years, 59.3% had 20/20 or better VA, and 94.7% had 20/40 or better uncorrected VA if BSCVA was 20/20 and patients were targeted for emmetropia; 67.5% of patients were within 0.5 D and 88.2% were within 1.0 D of predicted refraction. The mean improvement in BSCVA ranged between 0.5 and 0.6 lines. At 3 years postoperatively, 3 eyes (0.8%) decreased by >or=2 lines of BSCVA, in contrast to 40 eyes (10.8%) that improved by a similar amount. Contrast sensitivity improved postoperatively. Cumulative 3-year corneal endothelial cell loss was under 10%. Early largely asymptomatic, presumably surgically induced anterior subcapsular opacities (trace or greater) were seen in 14 eyes (2.7%), with only 2 being clinically significant. Five eyes (0.9%) of 3 patients developed nuclear opacities of grade >2 at 2 to 3 years postoperatively. Three (0.6%) ICL removals with cataract extraction and IOL implantation have been performed. Only 0.6% reported dissatisfaction; 97.1% of patients reported they would choose ICL implantation again. Incidences of patient symptoms, glare, halos, double vision, night vision problems, and night driving difficulties decreased or remained unchanged after ICL surgery. Three-year results from this standardized, multicenter clinical investigation support the safety, efficacy, and predictability of ICL surgery to treat moderate to high myopic refractive errors.

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The Implantable Collamer Lens with a central port: review of the literature

Mark Packer (2018)

The purpose of this review is to summarize preclinical and clinical data from publications appearing in the peer-reviewed scientific literature relevant to the safety and effectiveness of the EVO Implantable Collamer Lens (ICL) posterior chamber phakic refractive lens with a central port (V4c Visian ICL with KS Aquaport, STAAR Surgical, Inc.). A literature search was conducted using PubMed.gov to identify all articles relating to the EVO ICL. Articles were examined for their relevance, and the references cited in each article were also searched for additional relevant publications. On the basis of a total of 67 preclinical studies and clinical reports, including effectiveness data on 1,905 eyes with average weighted follow-up of 12.5 months and safety data on 4,196 eyes with weighted average follow up of 14.0 months, the EVO ICL is safe and effective for the correction of a broad range of refractive errors. High levels of postoperative uncorrected visual acuity, refractive predictability, and stability demonstrate the effectiveness of the EVO ICL. Safety data suggest reduced rates of anterior subcapsular cataract and pupillary block compared with earlier models. Improved safety and proven effectiveness make EVO an attractive option for surgeons and patients.

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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): opth

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

Publisher: Dove

ISSN (Print): 1177-5467

ISSN (Electronic): 1177-5483

Publication date (Electronic): 24 March 2023

Publication date Collection: 2023

Volume: 17

Pages: 969-980

Affiliations

[1 ]Department of Ophthalmology, Faculty of Medicine, Chulalongkorn University and King Chulalongkorn Memorial Hospital , Bangkok, Thailand

[2 ]Chula Refractive Surgery Center, King Chulalongkorn Memorial Hospital , Bangkok, Thailand

[3 ]Excellence Center for Cornea and Limbal Stem Cell Transplantation, Department of Ophthalmology, King Chulalongkorn Memorial Hospital, Faculty of Medicine, Chulalongkorn University , Bangkok, Thailand

Author notes

Correspondence: Ngamjit Kasetsuwan, Department of Ophthalmology, Faculty of Medicine, Chulalongkorn University , 1873 Rama 4 Road, Pathumwan, Bangkok, 10330, Thailand, Tel +6622564142, Email ngamjitk@gmail.com

[*]

These authors contributed equally to this work

Article

Publisher ID: 379856

DOI: 10.2147/OPTH.S379856

PMC ID: 10046236

PubMed ID: 36998514

SO-VID: a5300be3-a741-45f7-97ee-8d513935469c

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This work is published and licensed by Dove Medical Press Limited. 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. For permission for commercial use of this work, please see paragraphs 4.2 and 5 of our Terms ( https://www.dovepress.com/terms.php).

History

Date received : 19 December 2022

Date accepted : 15 March 2023

Page count

Figures: 0, Tables: 3, References: 102, Pages: 12

Funding

Funded by: Faculty of Medicine, Chulalongkorn University, open-funder-registry 10.13039/501100004776;

Intraocular Implantable Collamer Lens with a Central Hole Implantation: Safety, Efficacy, and Patient Outcomes

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Karger: Ophthalmology

Most cited references 97

Meta-analysis and review: effectiveness, safety, and central port design of the intraocular collamer lens

United States Food and Drug Administration clinical trial of the Implantable Collamer Lens (ICL) for moderate to high myopia: three-year follow-up.

The Implantable Collamer Lens with a central port: review of the literature

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