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Informations sur la sécurité

The EVO/EVO+ ICLs are indicated for patients who are 21 to 60 years of age and are available in spherical powers ranging from -3.0 D to -18.0 D for the correction/reduction of myopia with or without a cylinder power range from 1.0 D to 6.0 D. The hyperopic ICLs are indicated for patients who are 21 to 45 years of age and are available in powers ranging from +3.0 D to +10.0 D for the correction/reduction of hyperopia. In order to be sure that your surgeon will use an ICL with the most adequate power for your eye, your nearsightedness, farsightedness and astigmatism should be stable for at least a year before undergoing eye surgery. ICL surgery may improve your vision without eyeglasses or contact lenses. ICL surgery does not eliminate the need for reading glasses, even if you have never worn them before. ICL represents an alternative to other refractive surgeries including, laser assisted in situ keratomileusis (LASIK), photorefractive keratectomy (PRK), incisional surgeries, or other means to correct your vision such as contact lenses and eye glasses. Implantation of an ICL is a surgical procedure, and as such, carries potentially serious risks. The following represent potential complications/ adverse reactions reported in conjunction with refractive surgery in general: additional surgeries, cataract formation, loss of best corrected vision, raised pressure inside the eye, loss of cells on the innermost surface of the cornea, conjunctiva I irritation, acute corneal swelling, persistent corneal swelling, endophthalmitis (total eye infection), significant glare and/or halos around lights, hyphaema (blood in the eye), hypopyon (pus in the eye), eye infection, ICL dislocation, macular oedema, non-reactive pupil, pupillary block glaucoma, severe inflammation of the eye, iritis, uveitis, vitreous loss and corneal transplant. Before considering ICL surgery you should have a complete eye examination and talk with your eye care professional about ICL surgery, especially the potential benefits, risks, and complications. You should discuss the time needed for healing after surgery.

Informations de sécurité importantes concernant l'EVO/EVO+ ICL

L'EVO/EVO+ ICL est destiné aux patients âgés de 21 à 60 ans et est offert avec des puissances sphériques allant de -3,0 D à -18,0 D pour la correction ou la réduction de la myopie, avec ou sans puissance cylindrique, dans une plage de 1,0 D à 6,0 D. L'implantation de l'EVO/EVO+ ICL est une intervention chirurgicale et comporte, à ce titre, des risques potentiellement graves. Voici quelques complications/événements indésirables possibles : interventions chirurgicales additionnelles, formation de cataracte, perte temporaire ou permanente de la meilleure acuité visuelle corrigée, augmentation de la pression intraoculaire, perte de cellules à la surface la plus interne de la cornée, irritation conjonctivale, œdème cornéen, irritation conjonctivale, endophtalmie (infection totale de l'œil), éblouissements importants et/ou halos autour des lumières, hyphéma (sang dans l'œil), hypopyon (pus dans l'œil), infection oculaire, luxation de l'EVO/EVO+ ICL, œdème maculaire, pupille non réactive, glaucome par bloc pupillaire, inflammation oculaire sévère, irite, uvéite, perte du vitré et greffe de cornée. Avant d’envisager une chirurgie EVO/EVO+ ICL, vous devriez subir un examen complet des yeux et discuter avec votre professionnel des soins oculaires de la procédure EVO/EVO+ ICL, en particulier des avantages potentiels, des risques et des complications. Vous devriez aussi discuter du temps de guérison nécessaire après la chirurgie.

Références

Références

1. Patient Survey, STAAR Surgical ICL Data Registry, 2018

2. Sanders D. Vukich JA. Comparison of implantable collamer lens (ICL) and laser-assisted in situ keratomileusis (LASIK) for Low Myopia. Cornea. 2006 Dec; 25(10):1139-46. Patient Survey, STAAR Surgical ICL Data Registry, 2018

3. Naves, J.S. Carracedo, G. Cacho-Babillo, I. Diadenosine Nucleotid Measurements as Dry-Eye Score in Patients After LASIK and ICL Surgery. Presented at American Society of Cataract and Refractive Surgery (ASCRS) 2012.

4. Shoja, MR. Besharati, MR. Dry eye after LASIK for myopia: Incidence and risk factors. European Journal of Ophthalmology. 2007; 17(1): pp. 1-6.

5a. Lee, Jae Bum et al. Comparison of tear secretion and tear film instability after photorefractive keratectomy and laser in situ keratomileusis. Journal of Cataract & Refractive Surgery , Volume 26 , Issue 9 , 1326 - 1331.

5b. Parkhurst, G. Psolka, M. Kezirian, G. Phakic intraocular lens implantantion in United States military warfighters: A retrospective analysis of early clinical outcomes of the Visian ICL. J Refract Surg. 2011;27(7):473-481.

*American Refractive Surgery Council