Clinical Trial Three Year Follow Up

The 2004 Visian ICL clinical trial research study three-year follow-up reviewed by the FDA “supports the safety, efficacy, and predictability of Visian ICL surgery to treat moderate to high myopic errors.” ¹ The three-year data, based on the assessment of 351 eyes of 189 patients who reported at 3 years, also produced the following refractive results:

• 99 percent patient satisfaction.
• 98.3 percent of patients receiving <-7D lenses had uncorrected visual acuity of 20/40 or better.
• Once vision was corrected, the correction was stable and did not change over the follow up period.
• Additionally, the incidence of glare, halos, double vision, night vision problems, and night driving difficulties remained virtually unchanged from before surgery.

Visian ICL Myopia Research

This Clinical research shows that Visian ICL corrective procedures are safe and effective for treatment of myopia. Other clinical research has also shown that Visian ICL:

• can provide sharp, clear vision^{2, 3, 4,}
• does not induce dry eye syndrome⁵,
• provides excellent night vision⁶
• and can be a great option for patients with thin corneas^{7, 8}.

Potential patients or professionals wishing to learn more about the Visian ICL clinical results in patients with mild, moderate, or severe myopia should contact STAAR® Surgical Company.

Sources:

1. ICL in Treatment of Myopia (ITM) Study Group. United States Food and Drug Administration clinical trial of the Implantable Collamer Lens (ICL) for moderate to high myopia. Ophthalmology. 2004;111:1683-1692
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.
3. Shin, JY. Ahn, H. Seo, KY. Kim, EK. Kim, TK. Comparison of higher order aberrations after implantable collamer lens implantation and wavefront-guided lasek in high myopia. J Refract Surg. 2012; 28(2): 106-111.
4. Igarashi, A. Kamiya, K. Shimizu, K. Komatsu, M. Visual Performance after implantable collamer lens implantation and wavefront-guided laser in situ keratomileusis for high myopia. Am J Opthalmol. 2009.
5. By not removing and reshaping corneal tissue, the Visian ICL procedure does not induce dry eye syndrome. 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.
6. Parkhurst, G. Prospective Comparative Trial of LASIK vs. ICL for Night Vision Performance. Presented at the Annual Meeting of the AAO, Chicago, 2010.
7. 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.
8. Gimbel, Howard V et al. Management of myopic astigmatism with phakic intraocular lens implantation. Journal of Cataract & Refractive Surgery , Volume 28 , Issue 5 , 883 – 886.