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Informacje o bezpieczeństwie

Ważne jest, aby pamiętać, że procedura Visian ICL została zatwierdzona przez amerykańską Agencję ds. Żywności i Leków (Food and Drug Administration, FDA), co oznacza, że została uznana za bezpieczną i skuteczną. Tak jak w przypadku każdego zabiegu należy wziąć pod uwagę pewne zagrożenia. W przypadku jakichkolwiek pytań lub wątpliwości należy porozmawiać z lekarzem posiadającym uprawnienia do wykonywania procedury Visian ICL. Pełne informacje znajdują się w Broszurze informacyjnej dla pacjentów.

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Ważna informacje o bezpieczeństwie

The EVO ICL Lens is intended for the correction of moderate to high nearsightedness. EVO ICL and EVO TICL surgery is intended to safely and effectively correct nearsightedness between -3.0 D to -15.0 D, the reduction in nearsightedness up to -20.0 D and treatment of astigmatism from 1.0 D to 4.0 D. If you have nearsightedness within these ranges, EVO ICL surgery may improve your distance vision without eyeglasses or contact lenses. Because the EVO ICL corrects for distance vision, it does not eliminate the need for reading glasses, you may require them at some point, even if you have never worn them before.

Implantation of the EVO ICL is a surgical procedure, and as such, carries potentially serious risks. Please discuss the risks with your eye care professional. Complications, although rare, may include need for additional surgical procedures, inflammation, loss of cells from the back surface of the cornea, increase in eye pressure, and cataracts.

You should NOT have EVO ICL surgery if:

  • Your doctor determines that the shape of your eye is not an appropriate fit for the EVO ICL
  • You are pregnant or nursing
  • You have moderate to severe damage to the optic nerve caused by increased pressure (glaucoma)
  • You do not meet the minimum endothelial cell density for your age at the time of implantation as determined by your eye doctor
  • Your vision is not stable as determined by your eye doctor

Before considering EVO ICL surgery you should have a complete eye examination and talk with your eye care professional about EVO ICL surgery, especially the potential benefits, risks, and complications. You should discuss the time needed for healing after surgery. For additional information with potential benefits, risks and complications please visit DiscoverICL.com

Referencje

Referencje

1Patient Survey, STAAR Surgical ICL Data Registry, 2018

2Sanders 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.

3Naves, 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.

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

5aLee, 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.

5bParkhurst, 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