May 26 2010
STAAR surgical company declared that its Visian Implantable Collamer Lens (ICL) has received the CE Mark approval.
"CE Mark Approval for Visian ICL"
STAAR deals with the marketing and manufacturing of ophthalmic products that are minimally invasive. Visian’s Hyperopic Toric ICL is devised for astigmatism and hyperopia patients. Hyperopia or farsightedness is a condition in which patients find it difficult to focus closer objects. An unevenly shaped cornea may lead to astigmatism, which makes the vision blurred.
According to Barry G. Caldwell, CEO of STAAR Surgical, Hyperopic ICL can be used to treat patients with hyperopic range +0.5D to +2.75D. For myopic patents with range -0.5D to -2.75D, Visian ICL can be employed for treatment and astigmatic patients with hyperopia and myopia in the range up to 6D can be treated with Visian ICL. The increments of quarter diopter for hyperopes and low myopes can help in the optimization of the refractive target of the LASIK range.
The new Visian ICLs are available in selected counties in the range of -18.0D for myopics to +10.0D for hyperopics without interruption. Toric ICLs are also available for the entire range up to 6.0D of cylinder. The approval of CE mark is now extended to quarterly increments from 0.5 increments, which is for the range -3.0D and +3.0D of diopter.
The ICL products’ diopter range will cover these entire diopters. In the positive spheric, 0.5D increments from +3.0D to +10.0D and 0.25D increments from +0.5D to +2.75D. In the negative spheric, 0.5D increments from -3.0D to -18.0D and 0.25D increments from -0.5D to -2.75D. In the case of Toric addition, for the entire dipoters ranging from -18.0D to +10.0D, 0.5D increments from +0.5D to +6.0D, which does not include quarter diopters, with 0.0D.
STAAR surgical has made several enhancements for reducing the difficulty level of physicians in using ICL at the time of implantation. The lubricity has been increased for injector cartridges. Perforating holes have been incorporated in the lens haptic, which helps to the remove viscoelastics. Laser marks have added for the TICL newly, which enhances the sight of the surgeon to view the axis at the time of implantation and prior to it.
Caldwell added that ICL products will be packaged to BSS, Balanced Salt Solution, and data will be furnished with the aim of improving the shelf life from two to five years. In 1997, STAAR Surgical obtained CE mark for ICL for the first time.