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About Visian ICL

Safety

Potential Complications of the Visian ICL™ and Other Refractive Procedures

As with any type of surgery, the Visian ICL (Implantable Collamer® Lens) carries the risk of complications. To help educate prospective patients, the following information outlines some of the most common risks of the Visian ICL implant procedure and those of corneal refractive surgery. For detailed information regarding all possible complications, please ask a qualified Visian ICL surgeon. All refractive procedures, from LASIK surgery to implantable contact lens insertion, share possible complications.

 

Overcorrection and Undercorrection

The most common complications with any refractive procedure are overcorrection and undercorrection. A skilled surgeon will take meticulous measurements before surgery to determine the right amount of correction; however, these measurements are not always perfect. No matter the refractive procedure, undercorrection can be fixed with an additional procedure, which could include a second LASIK or PRK surgery or the removal and replacement of the Visian ICL. Continued use of glasses or contact lenses is also a possibility.

Infection

Because all of these procedures involve some form of manipulation (no matter how slight), there is a risk of an infection. Although it is not a common complication, it is important to realize that an eye infection may range from delaying the healing of the eye to serious damage, including possible loss of visual acuity.

Halos and Night Glare

The most common side effects of corneal refractive surgery are halos and glare around lights at night. These problems range in severity from being barely noticeable to severely limiting a person’s visual acuity. In many cases, severe halos and night glare can be reduced with a second surgery, but it is often difficult to eliminate these effects completely.

Loss of Visual Acuity

Although extremely rare, there is the possibility that a refractive procedure can cause damage to the eye including loss of visual acuity.

Complications with Corneal Surgery

Corneal surgery, including LASIK and PRK, requires that a small portion of the cornea be removed to change the shape and focusing ability of the eye.

Dry Eye

There is increasing concern in the ophthalmic community regarding dry eye and the decision to perform LASIK. Dry eye is a common disease that often causes patients to seek LASIK because of difficulty wearing contact lenses. According to Toda, et al, in the August 2002 Archives of Ophthalmology, “more than 75 percent of the patients undergoing LASIK have preoperative dry eye.” 1 Additionally, some 59.4 percent of those patients who do not have dry eye preoperatively will end up with it postoperatively2. There is also general consensus that worsening of preexisting dry eye occurs after LASIK.

Problems with the Corneal Flap

Some of the complications of LASIK eye surgery stem from the corneal flap. It may be too thin or too thick or sometimes irregular. Diffuse lamellar keratitis, or DLK, describes another flap-related problem that develops when infiltrates migrate beneath the flap. These complications are not associated with the Visian ICL surgery as the cornea remains untouched.

Visian ICL Complications

Some complications associated with the Visian ICL differ from those associated with LASIK or PRK. For a complete discussion of all complications, please ask your ophthalmologist.

Damage to the Crystalline Lens

Since the Visian ICL is placed inside the eye, potential risk touching the eye’s natural lens may result. Damage to the natural lens may cause an opacity of the lens, in the most serious case, requiring removal and replacement of the natural lens with a synthetic lens. These opacities, requiring surgical intervention, occurred in less than 1 percent of the Visian ICL patients3.

Complications of Iridotomy

One to two weeks prior to the implantation of the Visian ICL, the surgeon will perform a procedure called an iridotomy. Using a YAG-laser, the doctor will make one or two small openings near the edge of your iris. Complications from the iridotomy are rare, but could possibly include natural lens or corneal damage, inflammation, temporary increase in intraocular pressure, bleeding, and scar formation.

Increase in Eye Pressure

In some cases, there may be an increase in eye pressure. If this occurs, a surgeon may quickly remedy the problem with additional medications or surgical intervention.

Advantages over Laser Refractive Surgery

Many patients who compare the side effects of laser refractive eye surgery and implantable contact lens complications decide that the benefits of the Visian ICL far outweigh the rare risks associated with it. Because implantation of the lens does not physically change any part of the cornea or other part of the eye, some side effects found with Lasik do not apply to the Visian ICL. Also, should any problems with the lens arise, the Visian ICL is completely removable. If you are interested in undergoing the Visian ICL procedure, find a qualified Visian ICL Surgeon in your area who can discuss the risks and benefits as they pertain to your individual medical history and goals. To learn more about the clinical trials that assessed the safety of the Visian ICL, contact STAAR® Surgical Company today.

1  Toda I, Asano-Kato N, Hori-Komai Y, Tsubota K. Laser-Assisted In Situ Keratomileusis for Patients With Dry Eye. Archives of Ophthalmology. 2002;120(8):1024-1028 2 Yu E, Leung A, Rao S, Lam DSC. Effect of laser in situ keratomileusis on tear stability. Ophthalmology, 2000; 107:2131-2135 3 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

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