AcrySof® ReSTOR® Apodized Diffractive IOL - Seeclear.com

July, 25, 2005John A. Stefano, MD FACSAcrySof® ReSTOR®Apodized Diffractive IOLWHAT IS THE ReSTOR LENS?The AcrySof ReSTOR Apodized DiffractiveIntraocular Lens is the most recent innovationin lens implant technology. The ReSTOR lensis implanted in the eye as a lens replacementat the time of cataract surgery or refractivelens exchange. The best candidate is theindividual who is 55 or older who is dependenton glasses and/or contacts to see near, farand in-between.HOW DOES IT WORK? The AcrySofReSTOR IOL replaces the natural lens and is implanted into the eye in a procedureidentical to cataract surgery. It has a patented apodized diffractive optic design thatworks like a bifocal lens inside the eye. For long-distance vision, the ReSTOR lenscreates a clear image of the far away object while at the same time a second, highlydefocused image is created for near vision that is typically not perceived. For nearvision, the ReSTOR lens creates a clear, sharply focused near image and a secondhighly defocused far away image that is typically not perceived. This apodized diffractiveoptic design gives it the ability to provide clear vision near, far and in-between withoutmechanical movement of the lens.What is unique about ReSTOR? The lens has the ability to consistently offer patientsimproved vision at a range of distances, from close-up to middle and far. BecauseReSTOR doesn’t work with the muscles of the eye, it is not dependent on a mechanicalprocess or the movement of the lens to give clear vision.The ReSTOR lens is similar to two lenses in one. One, a refractive lens is for distance,the other, an apodized diffractive lens is for near vision. This gives ReSTOR moreconsistent results and more satisfied patients who can enjoy activities like reading,sewing, playing cards or looking at the fine print, all without the hassle of readingglasses, bifocals, progressive lenses or contact lenses.WHEN IS IT USED? The AcrySof ReSTOR IOL is used in adult patients with andwithout presbyopia, who desire near, intermediate and distance vision with increasedindependence from glasses following cataract or lens replacement surgery.Anyone who has a normal eye exam and is dependent on reading glasses or bifocalsmay be a candidate. Although ReSTOR lenses are a breakthrough technology initiallyapproved for cataract patients with or without presbyopia, it is not necessary to needcataract surgery to qualify for the ReSTOR lens, just a desire to.WHAT WILL THE RESTOR LENS ACCOMPLISH? The AcrySof ReSTOR IOL has

July, 25, 2005been shown in a clinical study to provide good near, intermediate and distance visionwith increased independence from glasses in patients who have undergone cataractsurgery.WHEN SHOULD IT NOT BE USED? There are no known contraindications. However,based on the FDA clinical trials, Alcon, the lens manufacturer, has indicated thefollowing types of patients possibly should not have the AcrySof ReSTOR ApodizedDiffractive IOL:• Individuals that are hypercritical with unrealistic expectations• Individuals with excessive complaints about their prescription• Individuals who drive at night for a living or whose occupation or hobbies depend ongood night vision• Individuals who are amateur or commercial airline pilots• Individuals who have life-long complaints about glare• Individuals who are happy wearing glasses• Individuals who want guarantees on surgical outcomesCLINICAL RESULTSThe FDA-approved AcrySof ReSTOR is a breakthrough in intraocular lens technologyfor most people with cataracts, with or without presbyopia, that may restore moreyouthful vision. Results from a controlled clinical study of the AcrySof ReSTOR IOLrevealed that maximum visual performance is achieved when the ReSTOR lens isimplanted in both eyes. Clinical data demonstrates that AcrySof ReSTOR IOL greatlyreduces dependence on glasses or bifocals:• 80% of patients reported that after lens implant surgery with ReSTOR lenses, theynever needed glasses or contact lenses to see clearly at all distances near, far andin-between.• 99% of patients could see well enough to drive a car without glasses or contacts• 97% of patients could read the newspaper without reading glasses or bifocals• 90% of patients could shave or put on makeup without glasses or contacts• 80% of patients NEVER wear glasses for any activitiesEveryone’s focusing ability is different. Most people will be able to see clearly in thedistance, have very good reading vision and functional intermediate vision withoutglasses, but some people may be more comfortable with additional correction,particularly at night or in dim light or for long periods of computer work. After surgery withthe ReSTOR lens, it may be necessary for some people to wear glasses for distance,intermediate and/or near vision to obtain optimal visual acuity. The difference fromstandard lenses is that most people will not be as dependent on these supplementalvision aids to function normally.WHO IS A GOOD CANDIDATE FOR THE ReSTOR IOL?Virtually everyone who has cataracts and/or presbyopia (loss of ability to refocus visionnoticed after age 45) and is in good general health may be candidate for refractive lensexchange and/or cataract surgery with the ReSTOR lens. During an eye exam, anophthalmologist can determine if there are pre-existing conditions that would make lensreplacement surgery with the ReSTOR not advisable.People who have had prior corneal refractive surgery (i.e. LASIK, IntraLASIK, RK orPRK) may be acceptable candidates for ReSTOR implantation as long as their eyes arein good health. Also individuals with more extreme levels of nearsightedness or

July, 25, 2005farsightedness may be better candidates for lens replacement surgery with the ReSTORlens than laser vision correctionIf you’ve already had cataract surgery, you may still be a candidate for the ReSTORlens. In some situations, a ReSTOR lens can be inserted in front of your existing fixedfocuslens implant in what is known as a piggyback lens configuration. Having apiggyback ReSTOR lens would be a way to upgrade your fixed focus vision to bettervision near and far as if the ReSTOR lens had been inserted at the time of your originalcataract surgery.WHAT CAN I EXPECT AFTER THE PROCEDURE?Similar to other lens implant procedures, you can expect your vision to be good the dayfollowing surgery. There is minimal discomfort after surgery that usually resolves withinhours. Most individuals can return to a normal work schedule/routine the day aftersurgery.HOW SOON AFTER THE PROCEDURE WILL I BE ABLE TO SEE AT VARYINGDISTANCES?For most patients, near vision is good the next day, and improves over the followingweek. Results are best when both eyes have ReSTOR lenses implanted.HOW MANY PATIENTS ARE 100% GLASSES FREE AFTER HAVING THE RESTORLENS IMPLANT?The results are very good. After having ReSTOR lenses implanted to both eyes, 80% ofpatients say they never wear glasses.WHEN DID THE ReSTOR RECEIVE FDA APPROVAL?March 23, 2005. It has been approved for use in Europe since April 4, 2003.WHEN DID DR. STEFANO START USING THE ReSTOR LENS IMPLANT?Dr. Stefano starting using the ReSTOR lens since it became available in the USA in thespring of 2005.WHAT ARE THE RISKS OF LENS REPLACEMENT SURGERY WITH THE ReSTORLENS IMPLANT?Lens replacement surgery is identical to cataract surgery and results in safe andsuccessful outcomes in approximately 98% of eyes treated. Like any surgical procedure,there are risks. The risks, benefits and surgical alternatives will be discussed with you.Fortunately, cataract surgery is one of the most common and safest surgical proceduresperformed in the US today with 2.7 million procedures performed annually.Additionally, individuals who are planning to receive the ReSTOR lens may needadditional surgery to “fine-tune” their vision. These procedures may be done before,during or after the ReSTOR lens is inserted. In rare instances a monofocal lens implantmay be used during surgery rather than the ReSTOR.IS THIS A REVERSIBLE PROCEDURE?Once the natural lens is removed, it cannot be replaced. However, if one is over 40 anddependent on reading glasses or bifocal the lens is already not normal. It has lost itsaccommodation ability. If the patient desires, the ReSTOR lens implant can be removedand replaced. In the US arm of the FDA Clinical Trials for ReSTOR, no patient requested

July, 25, 2005removal of the lens because the benefit of a full range of vision outweighed theircomplaints of visual disturbances. The only medical indication for lens replacement is ifthe lens power needs to be changed to help distance vision.IS THE LENS MORE EFFECTIVE THAN OTHER LENS IMPLANTS? The ReSTORlens is like two lenses in one. One refractive lens is for distance, and the other one, adiffractive lens, is for near. ReSTOR is not dependent on the movement of the lens buthas a unique Apodized Diffractive optic that is new to IOL design. The optical design ofthe lens distributes light between near vision and distant vision to accommodate vision ata range of distances. The ReSTOR lens does not rely on movement of the lens implantinside the eye to produce clear near and far vision.Standard monofocal (fixed-focus) lens implants provide excellent vision after cataractsurgery. With a standard lens implant, most individuals will need bifocal glasses and/orcontacts to have clear vision near and far. With the ReSTOR, you have the opportunityto see near and far seamlessly without glasses and have more youthful vision..The advantages of the ReSTOR lens over monofocal lens: are that in FDA studies, 80%of patients who have restor lenses in both eyes “never” wear glasses for any tasks on adaily basis.A disadvantages of the ReSTOR lens in comparison with the monofocal lens is thatthere is a 5% chance of severe nighttime glare and haloes with the ReSTOR that maymake night driving difficult.WILL INSURANCE COVER FOR THE RESTOR LENS?Most private medical insurances and medicare will not cover the costs associated withsurgery using ReSTOR lens when it is used purely as a refractive procedure intended toremove a patient’s dependence on glasses. Because use of the ReSTOR lens is not a"medical necessity," in the same way that LASIK is not a “medical necessity” patients,receiving the ReSTOR lens will be responsible for payment of the surgery, lens implantand surgery center charges. However, in instances for patients with visually significantcataracts, your private medical insurance and/or medicare may pay for cataract surgerybut not the costs associated with the upgrade to the ReSTOR. The medical insurancewill cover the basic costs of the cataract surgery with the patient being responsible forpaying for the upgrade to the ReSTOR lens, as an out of pocket expense.WHAT IS THE DIFFERENCE BETWEEN THE RESTOR LENS AND A STANDARDINTRAOCULAR LENS (IOL)? The ReSTOR lens allows for continuous vision up close,far away and at all distances in between, in most cases with patients experiencing thesame vision they had when they were younger, without the inconvenience of correctivelenses. In contrast, standard (single vision, fixed focus) lens implants provide vision at afixed distance and do not have the ability to provide a full range of near, intermediateand far vision. Most people with single vision implants must wear glasses for near visionand may need to wear glasses for intermediate/arm’s length vision as well.

July, 25, 2005AcrySof® ReSTOR® Apodized Diffractive IOL