/ When is the Visian ICL is the treatment of choice?
The Visian ICL (Implantable Collamer Lens)
By Craig S. Bindi
Some patients may not be ideal candidates for LASIK or Epi-LASIK. For patients with extreme nearsightedness, very thin corneas, or asymmetrically-shaped corneas, the Visian ICL may be the preferred method of vision correction. I wrote this brief article to explain about my experience with the Visian ICL since it was approved by the FDA in 2005.
The Visian ICL (Implantable Collamer Lens) is a lens implant, which is capable of correcting extremely large amounts of nearsightedness (ranging from –3.0 D to –20.0 D). This is well beyond the range of LASIK (ranging from -1.0 D to -12.0 D). The soft, flexible nature of the Visian ICL allows it to be inserted behind the cornea through a self-sealing micro-incision. This procedure can be thought of as similar to placing a contact lens inside the eye, to stay there indefinitely or removed if necessary, so it is sometimes referred to as an “insertable contact lens”. The lens is made of a very biocompatible material, called Collamer, that doesn’t cause a reaction inside the eye. It also filters ultraviolet light.
The U.S. FDA approved the Visian ICL for patients between the ages of 21-45 in 2005 after reviewing the long term data, but it has been available worldwide since 1995. In the FDA clinical studies, 526 eyes underwent the lens implant procedure, averaging -10 D of preoperative nearsightedness. Three years after the procedure, nearly 95% of patients had “20/40 vision or better” without glasses (4). These are remarkably good results considering the extremely high level of nearsightedness that was treated.
Lens implants/inserts have been used for over half a century in various forms of eye surgery, such as cataract surgery. With the Visian ICL, the eye’s natural lens is left in place. The lens implant procedure is done as an outpatient procedure, under topical eye drop anesthesia. Most patients experience little to no discomfort during the actual procedure, which takes about 15 minutes. Most patients report a nearly instantaneous improvement in their vision within hours, similar to LASIK.
In the FDA clinical studies, 93.6% of patients (averaging -12.6 D nearsightedness) saw “20/40 or better” without glasses one year after the procedure. At three years after the procedure, 92% of patients had uncorrected vision of “20/40 or better”, and 61.7% were seeing “20/25 or better” without any glasses (1). In a recent study published in the scientific journal Ophthalmology, for the treatment of extreme nearsightedness (between – 9.00D and –19.50D), 72.2% of patients who received underwent lens implants in one eye and LASIK in the other preferred the vision in the lens implant eye over the LASIK eye because of the better quality of vision (3).
1) Continued follow-up reinforces efficacy, safety of myopic phakic IOL. Ophthalmology Times, October 23, 2004. FDA Clinical Trials, Data on file, Ophtec USA, Inc.
2) El Danasoury MA, Maghraby AE, Gamali TO. Comparison of Iris-fixed Artisan Lens Implantation with Excimer Laser In Situ Keratomileusis in Correcting Myopia between –9.00 and –19.50 Diopters. Ophthalmology, 2002; 109:955-64.
3) FDA Clinical Trials, Data in file, Staar Surgical, Inc.
4) DR Sanders MD PHD, JA Vuchick MD. Comparison of Implantable Contact Lens and Laser Assisted In Situ Keratomileusis for Moderate to High Myopia. Cornea, 22 (4): 324-331, 2003.
FOR MORE INFORMATION, VISIT: www.visianinfo.com