AUSTIN EYE CLINIC
AUSTIN LASER AND REFRACTIVE CENTER

CRYSTALENS, RESTOR LENS & OTHER SURGICAL OPTIONS TO CORRECT PRESBYOPIA

THE CRYSTALENS:
The FDA-approved Crystalens is the first and only intraocular lens (IOL) replacement for cataracts that focuses like the eye’s natural lens, allowing for continuous vision up close, far away and all distances in between without glasses. . It is an intraocular lens replacement for the natural lens or cataracts that accommodates like the eye’s natural lens, allowing for seamless focusing up close, far away and at all distances in between, giving patients their best possible vision seamlessly. Unlike standard fixed-focus intraocular lens (IOLs) implants, the Crystalens restores vision at all distances and in most cases eliminates the need for glasses and contacts for everyday tasks. The ability to focus at all distances is a singular advantage over all current cataract procedures.

HOW DOES THE CRYSTALENS WORK?
The Crystalens is implanted into the eye in a procedure identical to cataract surgery.

(left to right) Mitchel Wong, MD, J. Stuart Cumming, MD, F.A.C.S., FRCOphth , co-founder, Director and Chief Scientific Officer, the inventor of eyeonics, inc.'s crystalens, and Shannon Wong, MD.

The natural lens of the eye is removed and the crystalens is implanted into the natural structure that supports the natural lens inside the eye. By using the eye ’s muscle to move the lens backwards and forwards naturally in response to the brain’s desire to see at different distances, Crystalens enables the eye to focus continuously and seamlessly through a range of distances, including near, far and everything in between. Patients experience the same vision they had when they were younger, for most without the inconvenience of corrective lenses. This outpatient procedure is painless, done with eyedrop anesthetic, and is done in our surgical center on Jollyville Road. Currently, cataract surgery is the most common surgery performed in the US with more than 2.7 million procedures performed annually.

HOW WELL DOES THE CRYSTALENS WORK?
In support of its Pre-Market Device approval, eyeonics, inc. presented results of its clinical trials. At 17 clinical sites, 497 eyes in 324 patients at least 50 years old with cataracts were implanted with Crystalens. The mean age of the study patients was 69.7 years old. Almost all of the study participants enjoyed dramatic benefits from the Crystalens procedure. 97.6% of patients implanted bilaterally had uncorrected distance vision of 20/30 or better, and 98.4% could see at J1 intermediate and J3 at near. At near, these patients were able to read the 6 point fine print on an Advil bottle. In addition, 93.5% of bilaterally implanted subjects had uncorrected near visual acuity of J2 at one year, and a number of patients enjoyed 20/20 vision in all three ranges (see chart). Clinical trials clearly demonstrated that Crystalens provides a range of visual acuity from near to distance. In addition, A-scan ultrasound measurements demonstrated that Crystalens was indeed moving forward. Crystalens has hinges adjacent to its optic, which allow forward and backward movement of the lens along the axis of the eye. It is a modified plate haptic lens with a biconvex optic.

The Crystalens is designed to take advantage of vitreous cavity pressure changes by locating against the vitreous face. This allows the lens optic to move forward and backward in response to ciliary muscle contractions and relaxation as well as to pressure changes between the vitreous cavity and the anterior chamber. The hinged haptics facilitate axial movement of the Crystalens optic by minimizing resistance.

Other highlights of the clinical trial:

• Adverse events reported for the Crystalens during the course of the study were comparable to those experienced with standard intraocular lenses.
• Hinges are durable and showed no signs of fatigue after one million cycles of testing at 10 cycles per second.

The outstanding functional benefits of the Crystalens, are perhaps best measured by the reactions of the study participates. In a survey designed to gauge the ability of Crystalens to reduce or eliminate the need for spectacles, 93.8% of patients said they were able to perform most daily activities without glasses. When specifically asked, “How often do you wear spectacles,” 73.5% of bilaterally implanted subjects responded, “Almost none of the time.”

For More information about the Crystalens goto www.crystalens.com.

FDA Clinical StudyVisual Outcomes with the Crystalens (one year after surgery) showed:

1. 97.6% of bilaterally treated patients saw 20/30 or better for distance (far) vision without glasses.
2. 98.4% of bilaterally treated patients can read the newspaper size print, including print the size of the stock quotes of the Wall Street Journal without glasses.
3. 100% could see intermediate (24-30”) without glasses (eg computer, dashboard, store labels).
4. 73.5% reported that they wore glasses never or almost never for far and/or near vision.
5. 92% of bilaterally treated patients saw 20/25 or better for distance (far) vision without glasses.

Visual Acuity 20/40 or Better

SOURCE: eyeonics, inc. PMA submission for Crystalens

HOW MUCH DOES THE PRESBYOPIA SURGERY WITH THE CRYSTALENS LENS COST?
Implanting the crystalens or the restor or rezoom IOL is a high-precision procedure requiring the skill of a highly trained ophthalmic surgeon. The global fee for the restor lens replacement/cataract surgery is $4600 per eye. This fee includes the surgeons fee, crystalens lens implant, operating room fee and intraocular lens adjustments that may be needed during the perioperative period.

Most private medical insurances and medicare will not cover the costs associated with surgery using the crystalens, rezoom or restor lens. Because use of the crystalens, rezoom and restor lenses is not a "medical necessity," patients receiving these deluxe lens implants will be responsible for payment of the surgery, lens implant and surgery center charges. However, in some instances for patients with visually significant cataracts, your private medical insurance and/or medicare may pay for cataract surgery but not the costs associated with the upgrade to the restor or crystalens. If you have private medical insurance or medicare and have a visually significant cataract and wish to have the crystalens or restor, then your fee may be reduced to approximately $2850/eye for upgrading to one of these deluxe lens implants with your cataract surgery.

Two monthly payment programs - Care Credit and Bank of America Visa Platinum - are available to make the surgery more affordable. There is no prepayment for financing. To apply for financing from Care Credit, you may call CareCredit at 1-800-300-3046 or apply online at www.carecredit.com. We offer a 3 month no-interest, and extended payment plans of 2, 3, 4 and 5 years.

Bank of America Visa Platinum Credit Card offers 0% fixed introductory annual percentage rate (APR) on purchases and balance transfers (not cash advances) for 6 months. Click here apply for the Bank of America Visa Platinum Credit Card

Cost is an important consideration, but surgeon experience with lens replacement surgery, personalized attention from the surgeon before and after your procedure, and the technology used are the most important factors in determining how well you see after surgery.

WHAT IS THE DIFFERENCE BETWEEN THE CRYSTALENS ACCOMMODATING LENS AND A STANDARD INTRAOCULAR LENS (IOL)?
The Crystalens accommodating intraocular lens allows for continuous vision up close, far away and at all distances in between, in most cases with patiencts experiencing the same vision they had when they were younger, without the inconvenience of corrective lenses.

In contrast, standard (single vision, fixed focus) lens implants provide vision at a fixed distance and do not have the ability to provide a full range of near, intermediate and far vision. Most people with single vision implants must wear glasses for near vision and may need to wear glasses for intermediate/arm’s length vision as well.

WHO ARE THE BEST CANDIDATES FOR THE CRYSTALENS IOL?
The Crystalens is ideally suited for men and women who have presbyopia and/or cataracts who want to restore their near, intermediate and distance vision. Also individuals with more extreme levels of nearsightedness or farsightedness may be better candidates for lens replacement surgery with the crystalens than laser vision correction.

IF I’VE HAD LASIK OR INTRALASIK CAN I STILL BE A CANDIDATE FOR CRYSTALENS?
Yes. People who have had prior corneal surgery are acceptable candidate for Crystalens implantation as long as their eye is in good health. Consult with your ophthalmologist to understand the issues associated with use of the crystalens after prior laser vision correction.

Additionally, individuals who are planning to receive a crystalens may need additional surgery to “fine-tune” their vision. These procedures may be done before, during or after the crystalens is inserted. In rare instances a monofocal or multifocal lens implant may be used during surgery rather than the crystalens.

For more information about Surgical Vision Correction with the Crystalens, schedule a free consultation with Dr. Mitchel Wong or Dr. Shannon Wong or attend one of our monthly surgical vision correction seminars.

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