Long-Term Vault Changes in Different Levels and Factors Affecting Vault Change After Implantation of Implantable Collamer Lens with a Central Hole

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Abstract

Introduction

This study evaluated vault changes in eyes implanted with an implantable Collamer lens (ICL) with a central hole (ICL V4c) for myopia and astigmatism correction as well as factors related to vault changes over time.

Methods

This retrospective study enrolled 169 myopic eyes from 169 patients (137 women and 32 men) who underwent ICL V4c implantation to correct myopia and astigmatism. Vault values were measured quantitatively using a rotating Scheimpflug camera. Each patient underwent at least four postoperative follow-up visits at 1 month, 6 months, 1 year, and more than 2 years. We compared postoperative values between groups and identified factors affecting vault changes over time.

Results

The mean vaults at 1 month (baseline), 6 months, 1 year, and the last follow-up time following ICL implantation were 540.83 ± 186.13, 520.00 ± 196.08, 503.79 ± 198.30, and 471.42 ± 211.35 μm, respectively. Eyes with baseline vaults of 250–750 and ≥ 750 μm exhibited a trend of vault decrease over time, and the differences were statistically significant ( P < 0.05) at 6 months and 1 year postoperatively, respectively. The variables relevant to the value of vault decrease between baseline and last follow-up time were anterior chamber depth (ACD) and ICL power (adjusted R ² = 0.121, P < 0.001).

Conclusions

We found a trend of decreased mean objective vault values over time, which was more obvious in eyes with higher baseline vault values. The vault value of the ICL decreased more in eyes with shallower ACDs, higher ICL power, or both. Moreover, the decrease in vault values became statistically significant earlier in eyes with higher baseline vaults or shallower ACDs.

Related collections

Most cited references 29

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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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Evaluation of central and midperipheral vaulting of the posterior chamber phakic intraocular Collamer lens (ICL; Staar Surgical Inc., Monrovia, CA) in eyes with moderate to high myopia.

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Implantable contact lens for moderate to high myopia: relationship of vaulting to cataract formation.

Jean-Philippe Girard, Michel Gonvers, C Bornet (2003)

To study cataract formation in eyes with an implantable contact lens (ICL) used for moderate to high myopia. University Eye Hospital, Lausanne, Switzerland. An ICL (model V3 or V4, Staar Surgical AG) was implanted in 75 eyes. Three months after surgery and again at the last follow-up examination, the transparency of the crystalline lens was assessed on transilluminated photographs and the vaulting of the ICL over the crystalline lens was evaluated. Central vaulting was measured precisely on digitized photographs taken with a 75 SL Zeiss slitlamp camera, while peripheral vaulting was estimated on photographs obtained with a Scheimpflug camera. The minimum follow-up was 12 months; the mean was 21.8 months. At the last follow-up, 20 of the 75 eyes (27%) had an ICL-induced anterior subcapsular cataract (ASCC). The number of cataracts increased with the duration of the follow-up. Cataracts developed more commonly in older patients than in younger patients. All 20 cataracts occurred when the central vaulting was equal to or less than 0.09 mm. In 26 eyes with the same range of vaulting (among which 11 had no vaulting), the lenses were clear at the last visit. The 20 patients with cataract and the 26 patients with clear lenses matched in age and duration of follow-up but not in myopia. No touch between the ICL and the crystalline lens was encountered when the central vaulting was equal to or greater than 0.15 mm. Vaulting showed a slight decrease over time. No statistically significant difference in vaulting was found between models V3 and V4. Central and/or peripheral contact between the ICL and the crystalline lens may be responsible for the high incidence of ASCC formation in this study. Central vaulting greater than 0.09 mm appears to protect the crystalline lens from cataract formation. However, we recommend aiming for higher central vaulting (0.15 mm) to avoid contact between the ICL and the crystalline lens. This should be attainable by implanting longer ICLs.

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Author and article information

Contributors

Xiaoying Wang:

ORCID: http://orcid.org/0000-0001-5419-6318

doctxiaoyingwang@163.com

Xingtao Zhou: doctzhouxingtao@163.com

Journal

Journal ID (nlm-ta): Ophthalmol Ther

Journal ID (iso-abbrev): Ophthalmol Ther

Title: Ophthalmology and Therapy

Publisher: Springer Healthcare (Cheshire )

ISSN (Print): 2193-8245

ISSN (Electronic): 2193-6528

Publication date (Electronic): 6 November 2022

Publication date PMC-release: 6 November 2022

Publication date (Print): February 2023

Volume: 12

Issue: 1

Pages: 251-261

Affiliations

[1 ]GRID grid.8547.e, ISNI 0000 0001 0125 2443, Eye & Ear, Nose, and Throat Hospital, , Fudan University, ; No. 19 BaoQing Road, XuHui District, Shanghai, 200031 China

[2 ]GRID grid.8547.e, ISNI 0000 0001 0125 2443, National Health Commission Key Lab of Myopia, , Fudan University, ; Shanghai, China

[3 ]GRID grid.411079.a, ISNI 0000 0004 1757 8722, Shanghai Research Center of Ophthalmology and Optometry, ; Shanghai, China

Author information

Xiaoying Wang http://orcid.org/0000-0001-5419-6318

Article

Publisher ID: 606

DOI: 10.1007/s40123-022-00606-8

PMC ID: 9834492

PubMed ID: 36335511

SO-VID: 51086c56-2f48-4793-bd1b-bb2e47da9b83

License:

Open AccessThis article is licensed under a Creative Commons Attribution-NonCommercial 4.0 International License, which permits any non-commercial use, sharing, adaptation, distribution and reproduction in any medium or format, as long as you give appropriate credit to the original author(s) and the source, provide a link to the Creative Commons licence, and indicate if changes were made. The images or other third party material in this article are included in the article's Creative Commons licence, unless indicated otherwise in a credit line to the material. If material is not included in the article's Creative Commons licence and your intended use is not permitted by statutory regulation or exceeds the permitted use, you will need to obtain permission directly from the copyright holder. To view a copy of this licence, visit http://creativecommons.org/licenses/by-nc/4.0/.

History

Date received : 22 September 2022

Date accepted : 21 October 2022

Funding

Funded by: FundRef http://dx.doi.org/10.13039/501100001809, National Natural Science Foundation of China;

Award ID: 82171095

Award ID: 81770955