Overview of Phakic IOLs
LASIK, a surgical procedure which uses a laser to reshape the cornea, is currently the most common form of refractive surgery (surgery to reduce or eliminate the need for glasses). Over the last ten-plus years, LASIK has proven to be a very effective and relatively safe alternative to glasses and contact lenses for many patients. However, patients with extremely high prescriptions, extremely thin corneas, or unusually shaped corneas often present challenges with LASIK. Some patients are better candidates for other types of procedures. Surgical options which do not involve reshaping the cornea are now available in the US, and are allowing patients previously untreatable with LASIK to experience the benefits of refractive surgery. One such option is a category of procedures known as "Phakic IOLs.”
“Phakic” refers to an eye which has its natural lens in place (“aphakic” is an eye which has had its natural lens removed). IOL stands for “Intra-Ocular Lens”—these are small artificial lens implants which have been used for over half a century in various forms, usually in conjunction with cataract surgery (surgery to remove a cloudy natural lens from the eye). The term “Phakic IOL” means an artificial lens which is implanted inside the eye, leaving the eye’s natural lens in place. This procedure can be thought of as placing glasses or contact lenses inside the eye, to stay there indefinitely. There are different styles of phakic IOLs, made of various materials, and there are several potential implantation sites within the eye. Some are implanted in front of the iris (the colored part of the eye), and some behind the iris.

The implantation of a phakic IOL is done as an outpatient in an ambulatory surgery center, under local or topical (eyedrop) anesthesia. A small incision (a few millimeters) is made to allow the insertion of the implant. Most patients experience little to no discomfort during the actual procedure, which may take thirty to sixty minutes. Remarkably, many patients report an instantaneous, dramatic improvement in their vision, similar to LASIK.

Click here to read information provided by the FDA about Phakic Intraocular Lenses.

Click here download our Phakic IOL - an alternative to LASIK brochure.

Verisyse™ IOLs
The first phakic IOL to receive full FDA approval is the Verisyse™ lens. It was approved in October 2004, for the reduction or elimination of nearsightedness ranging from –5.00D to –20.00D. This is well beyond the range of LASIK, which is approved to treat up to –14.00D (however, many doctors do not go this high with LASIK even though it is approved), and custom LASIK, which is approved to treat up to –8.00D. The Verisyse™ lens is made of polymethylmethacrylate (PMMA, a type of plastic), and is placed in front of the iris, the colored part of the eye. The lens attaches to the iris and is therefore known as an iris-fixated lens.
This lens design has been used in Europe for nearly two decades. In that time, more than 150,000 phakic refractive procedures have been performed using the Verisyse™ design. The implant has shown excellent stability of vision over time, and a very high degree of predictability.

The Verisyse™ IOL

In the FDA clinical studies, in 204 eyes with one year of followup, 47% of eyes saw 20/20 or better uncorrected, and 93.6% saw 20/40 or better uncorrected. These are remarkably good results given the extremely high level of nearsightedness being treated (mean preoperative myopia was –12.6D). At three years postop, 92% had uncorrected vision of 20/40 or better, and 61.7% were seeing 20/25 or better uncorrected1. 91% of patients rated their satisfaction with surgery “favorable,” and 92% would recommend the procedure to a friend or relative2. In a recent study published in the scientific journal Ophthalmology, for treatments between –9.00D and –19.50D, 72.2% of patients who received Verisyse™ in one eye and LASIK in the other preferred the Verisyse™ eye because of the better quality of vision3.

Visian ICLs
The Visian ICL is a phakic intraocular lens which is placed behind the iris, in front of the natural lens in the eye. The Visian lens is capable of correcting from –3.00D to –20.00D of nearsightedness. It is made of collamer, a co-polymer that contains a small amount of purified collagen. It is very biocompatible (doesn't cause a reaction inside the eye) and stable. It also contains an ultraviolet light filter. The soft, flexible nature of the Visian ICL allows it to be injected into the eye through a very small incision. Typically, the small incision is self-sealing and no stitches are needed.

The Visian ICL

The FDA clinical trials for nearsightedness concluded in 1999, and worldwide, over 40,000 ICLs have been implanted to date. In the FDA clinical studies, 526 eyes were implanted with the ICL, with an average preop nearsightedness of -10.06D. At three years postop, 59% of eyes had 20/20 or better uncorrected vision, and nearly 95% had 20/40 or better uncorrected4. A recent study comparing the ICL to LASIK for correction between -8.00D and -12.00D showed a higher percentage of patients ending up with 20/20 or better uncorrected with the ICL (52%) than with LASIK (36%), at one year post-op5.

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