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Posted - 25 May 2005 : 16:26:06 Alcon Launches AcrySof ReSTOR Apodized Diffractive IOL Monday April 25, 6:12 pm ET Revolutionary Apodized Diffractive Technology Provides Highest Level of Freedom from Glasses
FORT WORTH, Texas--(BUSINESS WIRE)--April 25, 2005--Alcon, Inc., (NYSE:ACL - News) announced the launch of the AcrySof® ReSTOR® Intraocular Lens (IOL) at a press conference during the American Society of Cataract and Refractive Surgery (ASCRS) and the American Society of Ophthalmic Administrators (ASOA) Symposium in Washington.
Approved on March 21, 2005 by the U. S. Food and Drug Administration (FDA), AcrySof® ReSTOR® is the first and only IOL that uses apodized diffractive technology to provide cataract patients with and without presbyopia a quality range of vision. In clinical trials, 80 percent of patients reported "never" wearing reading glasses or bifocals following bilateral cataract surgery. The vast majority of patients who undergo cataract surgery today receive traditional IOLs, which typically require patients to use reading glasses or bifocals for near vision following surgery.
The AcrySof® ReSTOR® lens is a foldable IOL that represents breakthrough technology because of its unique, patented optic design, which allows patients to experience the highest level of freedom from glasses ever achieved in IOL clinical trials. The AcrySof® ReSTOR® IOL uses a combination of three complementary technologies: apodization, diffraction and refraction, to allow patients to experience a full range of high-quality vision without the need for reading glasses or bifocals. This range of vision without glasses is achieved through the optical properties of the IOL. The benefit for patients is a high level of spectacle freedom. Alcon has patented the application of apodization technology to an IOL, making the AcrySof® ReSTOR® lens the first and only apodized diffractive IOL.
"In almost 40 years, the three most important developments in ophthalmic surgery have been phacoemulsification, the IOL and the AcrySof® ReSTOR® IOL," said Richard Mackool, MD, clinical investigator of the AcrySof® ReSTOR® IOL and Director of The Mackool Eye Institute and Laser Center and Senior Attending Surgeon at The New York Eye and Ear Infirmary. "The AcrySof® ReSTOR® IOL is not only an innovative way to replace the human lens, but it most accurately restores the vision achieved with a normally functioning natural lens. It is the last piece of the puzzle that leads to better vision without glasses for the vast majority of patients."
AcrySof® ReSTOR® IOL does not rely on the ciliary muscle, which weakens with age, to enable the eye to quickly change focus to see objects at near, intermediate and far distances. This allows 80 percent of cataract patients with and without presbyopia (age-related vision loss) the ability to see clearly without the aid of glasses or bifocals.
"Once I received the AcrySof® ReSTOR® IOL, I was free of glasses," said Susan Byrne, New York resident and clinical trial patient. "It gave me the vision I had when I was in my 20's. Being able to see clearly without glasses is amazing and has truly changed my life."
Clinical trials were conducted in the United States and Europe to establish the safety and effectiveness of the AcrySof® ReSTOR® IOL. A total of 566 people received the AcrySof® ReSTOR® lens in the clinical trials. The mean patient age in the studies was 69. Since its introduction outside the U.S. in 2003, more than 11,000 AcrySof® ReSTOR® IOLs have been implanted in patients by more then 900 surgeons in Europe and in other countries.
Alcon has begun training U.S. surgeons on the new lens and shipments will begin in early-May. Many factors should be taken into consideration when choosing an IOL, so patients should consult with their ophthalmologist to determine if the AcrySof® ReSTOR® IOL is right for them. Due to current insurance and Medicare coverage, this IOL may not be available to all patients. |
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Dr. Q |
Posted - 25 May 2005 : 20:08:27 I would like to add a few comments about the ReSTOR lens, as I attended the April 2005 ASCRS meeting in Washington, DC, where the ReSTOR lens was a hot topic.
It is hard to underestimate the attractiveness of the ReSTOR's ability to correct both near and the distance vision. Whereas before, cataract surgery typically corrected the patient's distance vision, but left a need for reading glasses for up close, the ReSTOR lens can correct both, so the typical ReSTOR patient doesn't wear any glasses after surgery. Therefore, I believe the ReSTOR lens will soon become very popular with cataract patients.
Another role for the ReSTOR lens may turn out to be in the field of vision correction surgery. For a variety of reasons, some patients just aren't good candidates for laser vision correction. In a subset of these patients, particularly those over 40 who would benefit from enhanced reading vision, the ReSTOR lens will present a viable alternative.
After all, even with recent advancements in LASIK, patients who are over 40 and correct both eyes for distance vision still end up needing reading glasses. With the ReSTOR lens, they may not need any glasses at all.
In addition to the standard risks of intraocular surgery, the ReSTOR lens carries the possibility of glare at night. Patients who are contemplating it should discuss possible side effects with their surgeon in detail before hand.
I am taking the certification course for the ReSTOR lens in early June, and hope to start using it shortly thereafter. Hopefully, I can provide a better update soon. |
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