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Risks of the procedure

The Visian ICL has been studied in FDA trials and successfully implanted in over 125,000 eyes over the last 10 years. This experience has shown the implant to be very safe and effective. Nevertheless, all medical treatments have potential side effects and complications. Before choosing an elective procedure it is important that you understand these possible problems. Potential problems from the ICL procedure include:

Infection

Because an incision is made in the eye and the ICL is implanted through this incision, there is a risk that bacteria could enter the eye and cause an infection. This can occur even with the antibiotic medications used before and after the procedure. The risk of a severe infection is less than 1:1,000.

Cataract

A cataract or cloudy lens usually develops with aging. You may have heard of older people having cataract surgery. Trauma can also cause cataract development. The ICL surgery is a minor trauma to the eye. In the FDA study the rate of cataract developing that required surgery was only 0.6%. Patients who developed a cataract eventually required another surgery to fix this condition. Most people still end up with good vision without glasses after a successful cataract procedure.

High eye pressure

During the ICL procedure a thick gel is placed inside the eye to protect the delicate eye structures. This thick gel can block the fluid circulation and cause a short-term elevation in the eye pressure. This can usually be treated successfully with eye drops. It is also possible that the ICL can push the iris forward and block the drain of the eye. This may require medications or laser surgery to treat the condition. Your eye pressure will need to be checked later in the day after the procedure to make sure there are no pressure problems developing.

Retinal Detachment

The retina is the thin film that covers the inside of the eye like wallpaper covers a wall. A retinal detachment means the retina peels away from the eye. A retinal detachment usually requires surgery to repair the detachment. Eyes that are myopic or nearsighted usually are larger than normal, which leads to a thinner retina. Being nearsighted is a risk factor for developing a retinal detachment. In the FDA study 3 patients (less than 1%) developed a retinal detachment in the months after the surgery. Because these myopic eyes had risk factors for retinal detachment, it is difficult to tell whether the surgery was a contributing factor in these cases. As a nearsighted person you should have a good retinal exam at least once each year.

Lens sizing problems

Although several sets of measurements are made prior to ICL surgery, it is possible that the lens selected is smaller or larger than an ideal size. This occurs because of variability within biological systems that is difficult to measure. Problems of this nature that are severe enough to lead to an ICL exchange occur less than 5% of procedures.

Glare and nighttime vision issues

A lens implant has the potential to cause glare and halos at night. The normal eye response to darkness is to make the pupil get larger to let in more light. A healthy young person may have a very large pupil in dim illumination. If the pupil gets larger than the implanted lens, some light can hit the lens edge and bounce into the eye causing glare or halos. This same process can also happen with glasses, contact lenses, and LASIK procedures. In the FDA study, some patients reported symptoms of glare and halos related to their vision correction with glasses or contact lenses. After the procedure a few patients noted more noticeable symptoms of glare and halos. It was rare that this was considered severe or bothersome. For example 11% reported noticing moderate or severe glare before the procedure and 14% reported this symptom after the procedure. 20% of patients reported night driving difficulties before the procedure and 16% reported this after the procedure.
 






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