Safety and efficacy of toric implantable collamer lens V4c model – A retrospective South Indian study

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Abstract

Purpose:

The aim of this study was to evaluate the safety, efficacy, and complications of V4c Toric implantable collamer Lens (TICL) implantation for myopic astigmatism in the south Indian population.

Methods:

In this retrospective observational case series, a total of 109 eyes of 67 patients who underwent V4c TICL implantation (ICL, V4C Staar Surgical, Nidau, Switzerland) between January 2012 and August 2019 were studied with a minimum follow-up period of 6 months (mean 24 months). The main outcome measures were objective and subjective refraction, uncorrected distance visual acuity, corrected distance visual acuity (CDVA), safety, predictability, adverse events, and postoperative complications.

Results:

At 6 months, mean manifest refractive spherical equivalent (SE) decreased from - 10.90 ± 3.7D preoperatively to - 0.02 ± 0.13D postoperatively ( P < 0.001) and mean cylinder decreased from - 2.3 ± 1.3 D preoperatively to - 0.04 ± 0.2 D postoperatively ( P < 0.001). Postoperatively, SE within ± 0.5 D and ± 1.0 D of attempted correction were achieved in 96.3 (105 eyes) and 100% (109 eyes), respectively. Manifest refractive cylinder within ± 0.5 D and ± 1.0 D of attempted correction were achieved in 97.2 (106 eyes) and 100% (109 eyes), respectively. Sixty-two percent (68 eyes) showed no change in CDVA postoperatively, and no eye had lost lines of CDVA. The safety index was 1.12, and the efficacy index was 1.10. Complications were seen in two eyes (1.8%) due to high postoperative vault requiring secondary surgical interventions.

Conclusion:

V4c TICL is a highly effective, safe, and predictable option in treating myopic astigmatism with excellent improvement in vision and spectacle independence.

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Most cited references 34

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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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Posterior chamber collagen copolymer phakic intraocular lenses to correct myopia: five-year follow-up.

Marcus Paulo Fernandes Amarante, M Begoña Baamonde, F. Alfonso … (2011)

To evaluate the long-term safety and efficacy of posterior chamber collagen copolymer phakic intraocular lens (pIOL) implantation to correct myopia. Fernández-Vega Ophthalmological Institute, Oviedo, Spain. Cohort study. Uncorrected (UDVA) and corrected (CDVA) distance visual acuities, refraction, pIOL vault, endothelial cell loss, and adverse events were evaluated for 5 years after implantation of the Visian Implantable Collamer Lens pIOL for moderate to high myopia. The mean spherical equivalent (188 eyes) decreased from -11.17 diopters (D) ± 3.40 (SD) preoperatively to -0.88 ± 0.72 D 5 years postoperatively. The mean change in refraction from 1 month to 5 years was -0.65 ± 0.65 D. The mean UDVA and CDVA (Snellen decimal) were 0.69 ± 0.26 and 0.83 ± 0.15, respectively. The mean safety and efficacy indices were 1.27 ± 0.33 and 0.89 ± 0.35, respectively. No eye lost more than 2 lines of visual acuity; 70% achieved 0.80 or better CDVA. Three eyes (1.6%) developed late anterior subcapsular cataract that was clinically significant in 1 case, leading to pIOL removal and phacoemulsification. Of the 3 eyes (1.6%) with a mild transient increase in intraocular pressure (up to 27 mm Hg), none required a second surgical procedure or prolonged topical medication. The total endothelial cell loss (considered cumulatively at consecutive intervals through 5 years) was 7.7%. There was a tendency toward decreased pIOL vault decrease over time. No vision-threatening complications occurred. Implantation of the collagen copolymer pIOL for moderate to high myopia was safe and effective and provided long-term predictable, stable refractive results. Copyright © 2011 ASCRS and ESCRS. Published by Elsevier Inc. All rights reserved.

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Long-Term Comparison of Posterior Chamber Phakic Intraocular Lens With and Without a Central Hole (Hole ICL and Conventional ICL) Implantation for Moderate to High Myopia and Myopic Astigmatism

Kimiya Shimizu, Kazutaka Kamiya, Akihito Igarashi … (2016)

Abstract The study shows a promising next-generation surgical option for the correction of moderate to high ametropia. Hole implantable collamer lens (ICL), STAAR Surgical, is a posterior chamber phakic intraocular lens with a central artificial hole. As yet, however, no long-term comparison of the clinical results of the implantation of ICLs with and without such a hole has hitherto been conducted. A prospective, randomized, controlled trial was carried out in order to compare the long-term clinical outcomes of the implantation, in such eyes, of ICLs with and without a central artificial hole. Examinations were conducted of the 64 eyes of 32 consecutive patients with spherical equivalents of −7.53 ± 2.39 diopters (D) (mean ± standard deviation) in whom implantation of a Hole ICL was performed in 1 eye, and that of a conventional ICL was carried out in the other, by randomized assignment. Before 1, 3, and 6 months, and 1, 3, and 5 years after surgery, the safety, efficacy, predictability, stability, intraocular pressure, endothelial cell density, and adverse events of the 2 surgical techniques were assessed and compared over time. The measurements of LogMAR uncorrected and corrected distance visual acuity 5 years postoperatively were −0.17 ± 0.14 and −0.24 ± 0.08 in the Hole ICL group, and −0.16 ± 0.10 and −0.25 ± 0.08 in the conventional ICL group. In these 2 groups, 96% and 100% of eyes, respectively, were within 1.0 D of the targeted correction 5 years postoperatively. Manifest refraction changed by −0.17 ± 0.41 D and −0.10 ± 0.26 D occurred in from 1 month to 5 years in the Hole and conventional ICL groups, respectively. Only 1 eye (3.1%), which was in the conventional ICL group, developed an asymptomatic anterior subcapsular cataract. Both Hole and conventional ICLs corrected of ametropia successfully throughout the 5-year observation period. It appears likely that the presence of the central hole does not significantly affect these visual and refractive outcomes. Trial Registration: UMIN000018771.

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Author and article information

Journal

Journal ID (nlm-ta): Indian J Ophthalmol

Journal ID (iso-abbrev): Indian J Ophthalmol

Journal ID (publisher-id): IJO

Title: Indian Journal of Ophthalmology

Publisher: Wolters Kluwer - Medknow (India )

ISSN (Print): 0301-4738

ISSN (Electronic): 1998-3689

Publication date (Print): December 2020

Publication date (Electronic): 23 November 2020

Volume: 68

Issue: 12

Pages: 3006-3011

Affiliations

[1]Fellow in Cornea and External Diseases, Aravind Eye Hospitals and Post Graduate Institute, Tirunelveli, Tamil Nadu, India

[1 ]HOD, Cornea and Refractive Services, Aravind Eye Hospitals and Post Graduate Institute, Tirunelveli, Tamil Nadu, India

[2 ]HOD, Paediatric and Strabismus Services, Aravind Eye Hospitals and Post Graduate Institute, Tirunelveli, Tamil Nadu, India

[3 ]Consultant, Cornea and External Diseases, Aravind Eye Hospitals and Post Graduate Institute, Tirunelveli, Tamil Nadu, India

[4 ]Prof of Ophthalmology, Glaucoma Services, Aravind Eye Hospitals and Post Graduate Institute, Tirunelveli, Tamil Nadu, India

[5 ]Statistics, Aravind Eye Hospitals and Post Graduate Institute, Tirunelveli, Tamil Nadu, India

Author notes

Correspondence to: Dr. Venugopal Anitha, Department of Cornea, External Diseases and Refractive Surgery, Aravind Eye Hospital and Post Graduate Institute, Tirunelveli, Tamil Nadu, India. E-mail: aniths22@ 123456ymail.com

Article

Publisher ID: IJO-68-3006

DOI: 10.4103/ijo.IJO_1492_20

PMC ID: 7856968

PubMed ID: 33229687

SO-VID: 26fffb12-9d9e-48be-b521-be0d630c6fe9

License:

This is an open access journal, and articles are distributed under the terms of the Creative Commons Attribution-NonCommercial-ShareAlike 4.0 License, which allows others to remix, tweak, and build upon the work non-commercially, as long as appropriate credit is given and the new creations are licensed under the identical terms.

History

Date received : 19 May 2020

Date revision received : 14 September 2020

Date accepted : 25 September 2020

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Safety and efficacy of toric implantable collamer lens V4c model – A retrospective South Indian study

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Abstract

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Most cited references 34

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

Posterior chamber collagen copolymer phakic intraocular lenses to correct myopia: five-year follow-up.

Long-Term Comparison of Posterior Chamber Phakic Intraocular Lens With and Without a Central Hole (Hole ICL and Conventional ICL) Implantation for Moderate to High Myopia and Myopic Astigmatism

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