
Although ReSTOR lenses are a breakthrough technology initially approved for cataract patients, with or without presbyopia (inability to read close up after age 45), it is not necessary to need cataract surgery to utilize the ReSTOR lens, just the desire to restore eyesight at a range of distances without corrective eye wear. In the absence of a cataract, the procedure would be a Refractive Lens Exchange, and this would represent an off-label use of the ReSTOR lens, which is currently only FDA approved for use in cataract surgery. A careful examination and discussion with your eye doctor will determine if you are a candidate for this lens implant.
Please call Harvard Eye to schedule your qualifying exam. The best candidates will be those that have a strong desire to see well without glasses and have realistic expectations. Patients with ocular disease may not be good candidates for this implant.
For most patients, near vision is good the next day, and both near and distance vision improves over the following weeks. Studies have shown that results are best when both eyes have ReSTOR lenses implanted. We usually wait 2-4 weeks between implants.
The results are very good. After having ReSTOR lenses implanted, 80% of patients say they never wear glasses. Nearly 94% were so satisfied that they would have the procedure again.
During clinical trials, 566 people received the ReSTOR lens. However, ReSTOR is the same type of lens implant (acrylic lens) that has been in used in cataract surgery for many years, in hundreds of thousands of patients.
While very rare, the dominant risk in any surgery is infection. Patients receive both preoperative antibiotics and postoperative antibiotics to minimize this risk. Lens implant surgery is one of the most successful and commonly performed surgeries in the US.
Once the natural lens is removed, it cannot be replaced. However, if one is over 40 and dependent on reading glasses or bifocals, the natural lens has already lost significant accommodative ability. If the patient desires, the ReSTOR lens implant can be removed and replaced. During the FDA Clinical Trials for the ReSTOR lens, only two out of the 450 implants needed to be explanted due to patient dissatisfaction - because the benefit of a full range of vision outweighed any complaint of visual disturbance. The only medical indication for lens replacement would be if the lens power needed to be changed, which is uncommon due to advanced eye measurements and calculations that your eye doctor performs prior to surgery.
March 23, 2005. It has been approved for use in Europe since April 4, 2003.
As always, Harvard Eye is first and foremost concerned about what is best for each individual patient. Call us today for your personalized consultation!
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