Conductive Keratoplasty is vision procedure that uses radiofrequency (RF) energy instead of a laser to reshape the contours of your eye. By changing the way your cornea (the clear front surface of the eye) directs light to the rest of your eye, CK effectively treats the condition known as hyperopia (commonly called “farsightedness”

A Normal eye focuses light on the retina (the back surface of the eye) to create an image. In a farsighted (hyperopic) eye, where vision may be better at a distance than at close proximity, the curvature of the cornea is too flat. This causes the lens to focus light behind the retina, which results in blurred vision.

CK is an exciting option for patients with farsightedness. It is a new procedure that uses radio frequency energy instead of a laser. Radio frequency-just like the same signal you listen to from your favorite radio station. CK uses pinpoint accurate pulses of radio frequency energy to reshape and steepen corneal tissue resulting in improved vision, especially for reading. Radio frequency is one of today’s most advanced surgical technologies. It is routinely used in other procedures such as prostate cancer therapy, back surgery and cardiovascular procedures,

Because CK does not involve cutting or lasers, the procedure can be conveniently performed in the office using only an eye drop on anesthesia. The procedure takes about 3 minutes to perform, and the result is an immediate improvement in your vision and in most cases you can return to your normal schedule the next day.

FDA Approved

CK is an FDA approved procedure for mild to moderate hyperopia (up to =3 diopters), a condition in which the cornea is too flat or the eye is too short.

Benefits At-A-Glance

· CK is a safe, minimally invasive procedure
· CK is fast: The procedure is performed in under three minutes.
· CK is convenient and comfortable: It is performed in-office with only topical anesthesia.
· CK does not involve the cutting or removal of tissue there for it meets the needs of patients who are more risk-adverse.
· CK is the first alternative to laser for hyperopia successful

Continuing Studies

In addition to its U.S. approval hyperopia, CK is currently in U.S Phase III clinical trials for the treatment of presbyopia using a technique called monovision, in which one eye is treated for near vision and the other for distance vision. It is currently being under-treating resulting from LASIK (Laser In-Situ Keramolieusis) and PRK (photorefractive keratectomy).

How is CK performed?

CK uses the controlled release of radio frequency (RF) energy, instead of a laser, to reshape the cornea. CK is performed using a small probe, thinner than a strand of human hair, that releases radio frequency (RG) energy. The probe is applied in a circular pattern on the outer cornea to shrink small areas of corneal tissue. This circular shrinkage pattern creates a constrictive band (like the tightening of a belt), increasing the overall curvature of the cornea. The procedure, which takes less than three minutes, is done in-office with only topical anesthesia (eye drops).

Will you be cutting the cornea?

No. CK is performed without the cutting or removal of tissue. It is a safe minimally invasive procedure for farsightedness.

Is radiofrequency (RF) energy safe for use on the eye?
Yes. The use of RF energy is one of todays most advanced surgical techniques. In
addition to its use in CK, RF technology is being used in prostate cancer therapy, back surgery, even cardiovascular procedures.

Will my vision improve immediately after surgery?
Patients usually notice an immediate improvement in their vision after the CK procedure. However, it usually takes several weeks for the eyes to adjust to the final level of treatment.

Will my vision fluctuate after surgery is performed?
Most patients will experience mild fluctuation in their vision after the CK procedure. However, it usually takes several weeks. Patients who are treated for hyperopia, regardless of the procedure, usually require longer

Are both eyes treated on the same day?
For patients who require treatment in both eyes, CK is typically performed on both eyes on the same day – one eye immediately after the other. Most patients are comfortable having the CK procedure performed on both eyes on the same day because the it takes less than 3 minutes and is done in-office with only topical anesthesia.

Will I have to wear patches over my eyes after the procedure?
You will not have to wear patches or bandages, however many surgeons will recommend temporary clear lenses (similar to contact lenses but without a prescription) to protect eyes and reduce any potential discomfort.

How soon can I return to work?
With CK, the majority of patients are able to return to work and other normal activities the day of their procedure. Although recovery is fairly quick, it is advisable to be careful with your eyes and to avoid any strain. Those whose jobs demand intense clarity with your eyes and to avoid any strain (similar to contact lenses but without a prescription) to protect the eyes and to reduce any potential discomfort.

What will I feel during CK procedure?
The CK procedure is considered painless. You will be aware of support (speculum), which helps hold your eye open. The most common sensation that patients experience is a feeling of pressure on the eye. After surgery, there may be some mild discomfort, and may patients experience a foreign-object sensation or a slight “scratchiness” in the eye. This usually subsides within 24 hours of procedure

What type of anesthesia is used during the CK procedure?
A local anesthetic in the form of eye drops is used to numb the eye. Some patients who are very nervous and have a high level on anxiety about the procedure will be given a mild sedative to help them relax.

Why doesn’t CK use a laser?
CK is the first alternative to laser for farsightedness. Rather than removing tissue with a laser, CK reshapes the cornea using an entirely different method: the application of low level, radiofrequencey (RF) energy applied in a circular pattern on the outer cornea, to shrink small areas of corneal tissue. This circular pattern acts like a belt tightening around the cornea to increase its overall curvature. The procedure, which takes less than three minutes, is done in-office with only topical anesthesia (eyedrops).

Will the instrument used penetrate my cornea?
CK is performed using a prove (Keratoplast Tip) that is as thin as a strand of human hair. The prove, introduced into the cornea, applies controlled radiofrequency (RF) energy, stabilizes the CK procedure and guarantees the precise depth of treatment.

What are the risks and side effects of Conductive Keratoplasty?
Because CK is minimally invasive and extremely precise the procedure has minimal risk and almost no side effects. During the first 24 to 48 hours CK, you may experience tearing and some discomfort, including a foreign-object sensation in the eyes. You may also experience initial slight over correction of your vision, which stabilizes during the following weeks. However, because CK doesn’t cut or remove tissue, many of the side effects associated with other vision treatment procedures have not been observed with CK.

Are there restrictions after having CK?
As with any vision treatment procedure where the cornea is altered, certain precautions should be taken, After the CK procedure patients should avoid getting contaminated water in their eyes for at least one week. This includes water from swimming pools, spas, lakes and the ocean. When showering or taking baths, patients should keep their eyes closed in order to avoid getting soap and dirty water into their eyes. When exercising, sweat should be kept out of the eyes for at least one week after surgery. Also patients should avoid rubbing the eyes vigorously for two weeks following the procedure. Females should also avoid applying eye make up for one week after surgery

Will I ever need glasses or contacts again?
The vast majority of patients do not need corrective lenses of any kind after the CK PROCEDURE. However depending on your age and the type of refractive disorder you have, you may need additional vision treatment as some point (surgery, reading glasses or bifocals). This is because your eyes continue to change as you age, and no on can avoid applying eye makeup for one week after surgery.

Can CK treat astigmatism?
The CK procedure is being studied internationally for the treatment of astigamatism

Can CK treat presbyopia?
The CK procedure is currently in FDA phase III clinical trials to study its effectiveness in treating presbyopia. CK is being studied to treat presbyopia. CK is being studied to treat presbyopia through a technique called monovision, in which one eye is treated for near vision and the other for distance vision. The minimally invasive technique and excellent safety profile of CK offer the potential to change the way perbyopic patients are treated.

Can CK treat myopia (nearsightedness)?
CK was designed for hyperopia, or farsightedness, where the cornea requires steepening. CK is not designed to flatten the cornea, the effect required for the treatment of myopia

Can CK be used to treat over-or under-correction from LASIK or other refractive procedures?
CK is currently being studied in an international clinical trial for use in treating over – or under correction resulting from LASIK and PRK.

Is CK reversible?
As with most vision treatment procedures, CK is not reversible. Once the procedure has been performed, it is not possible to “remove” its effects. This is an important factor for anyone thinking about surgery to carefully consider. To make sure CK is right for you. Seek the advice of your surgeon.

Why did the FDA approve CK for the “temporary” treatment of hyperopia?
The FDA has recently changed its guidelines for stability because hyperopia is a progressive disease, which means as people age their level of farsightedness will increase- with or without surgical treatment.

Will my health insurance cover the cost of the CK procedure?
Because CK is considered elective surgery (cosmetic), most health insurance plans do not cover it. Financing options are available to make CK more affordable. For more information about financing, ask your eye surgeon.

Who is CK right for?
CK has been approved for patients with mild to moderate hyperopia (up to +3.00 diapers). The following are some basic criteria you must be considered a good candidate for CK.

· Be at least 40 years of age
· Have no drastic changes in vision or eyeglass prescription with in the past year
· Have no eye conditions such as glaucoma, severe dryness, keratoconus, herpes of the eye, aggressive keloid formation or corneal dystrophy
· Have no physical conditions such as diabetes, pregnancy or nursing, and vascular or autoimmune diseases

To determine if you are a candidate for CK, obtain a thorough examination from your eye surgeon, and seek his or her recommendations.

How is a precise amount of RF energy and depth of treatment ensured during the CK procedure?
The ViewPoint™ CK system was engineered and designed specifically for the CK procedure. This means the precise amount of RF energy needed to affect the corneal tissue, at the precise tissue temperature and depth of treatment, were meticulously investigated and defined. The Keratoplast™ Tip penetrates the cornea to a depth of 450um and utilizes a Teflon® stop at the very distal portion to assure precise depth of penetration.

What is the risk of the collagen being overheated and causing scarring?
The risk of collagen is being heated above the optimal or permanent shrinkage temperature is almost nonexistent with the CK system. Comprehensive thermal modeling and long-term clinical effectiveness and stability data consistently and accurately reaches the appropriate temperature to induce optimal tissue shrinkage.

Can CK be performed on patients who have a pacemaker?
The CK equipment can produce interference that may adversely influence the operation of other electronic equipment. Therefore, CK is not recommend for patients who are wearing pacemakers

What enables CK to be performed in-office?
CK is a minimally invasive procedure that does not require cutting of the cornea, and therefore does not carry associated risk of surgical complications. The procedure is relatively quick and easy to perform – taking an average of just 3 minutes

NEWS ABOUT CK

FDA APPROVES REFRACTEC’S® CKsm (Conductive Keratoplasty sm)
NON-LASER PROCEDURE FOR FARSIGHTEDNESS

CK uses Radiofrequency Energy, Instead of a LASER, to reshape the Cornea
Without Cutting or Removing Tissue

IRVINE, Calif., April 16, 2002 – Ophthalmic device manufacturer Refractec Inc. today announced that the U.S Food and Drug Administration has approved CK (Conductive Keratoplasty), a procedure for farsightedness (hyperopia) in people over age 40. CK utilizes the controlled release of radiofrequency (RF) energy instead of a laser or scalpel, to reshape the cornea. The minimally invasive CK procedure takes less than 3 minutes and is done in-office with only topical (eye drop) anesthesia.

Farsightedness, which occurs when the cornea is too flat or the eye is too short, is the most common vision disorder I America and affects more than 60 million people over age 40. Symptoms include difficulty reading menus, a computer screen and seeing to drive at night, or the need to constantly reposition reading material to find the right focus.

“For years, the farsighted have been left behind as vision correction progressed: RK (radial keratonomy), PRK (photorefractive keratectomy) even LASIK (LASER In-Situ Keratomileusis) initially, were all treatments designed specifically for the nearsighted,”
said world-renowned opthalmologist Marguerite B. McDonald, MD, medial monitor for the FDA clinical trials, director of the Southern Vision Institute and clinical professor of ophthalmology at Tulane University, New Orleans, LA. “CK is one of the first procedures designed specifically for the millions of people with hyperopia.”

Due to the flateness of the cornea, farsightedness is the most difficult disorder to treat with LASIK and the most likely to cause complications, according to Robert K. Maloney, MD principal FDA clinical investigator and director of the Maloney-Seibel Vision Institute in Santa Monica, Calif.

“Hyperopic LASIK accounts for about 20 percent of my practice, but 80 percent of the complications, because hyperopic patients are more likely, after LASIK, to get dry eyes, hazy vision or poor quality of vision, “ said Dr. Maloney.

Procedure Appeals to Risk-Adverse baby boomers
Baby Boomers (those born between 1946 and 1964) comprise the largest segment of the farsighted population, and many view the need for glasses as a sign of aging. Yet, hyperobic procedures comprise only a small percentage of the nearly 2 million U.S. refractive surgeries performed last year. Consumer research indicates that , to date, very few people between the ages of 40 to 60 have even considered vision correction surgery, as they tend to be more conservative and risk-adverse than their younger, nearsighted (myopic) counterparts.

“CK meets the need of the risk-adverse patient population, those who’ve been waiting for a safe, less invasive treatment for farsightedness, “ said Dr. Maloney. “ As the first approved alternative to a laser for treating hyperopia, it’s a very effective procedure and most of all, the patients love it. It’s quick. There’s very little post-op discomfort and immediate return of vision”

About the CK Procedure
CKsm can change how the eye focuses light by reshaping the cornea. CK uses A controlled release of radiofrequency energy to heat and shrink the corneal tissue, which steepens the cornea. This steepening results in the desired refractive effect.

“In the CK procedure we apply radiofrequencey energy to the eye through a tiny probe as thin as human hair, “ said Dr. Maloney. “We apply this energy in a circle and it causes contriction, almost like tightening a belt, which increases the curvature of the eye to treat farsightness”

The use of RF energy is one of today’s most advanced surgical techniques. In addition to its use on CK, RF technology is being used in prostate cancer therapy, back surgery, even cardiovascular surgery.

“During the CK Clinical Trials everybody we treated had an improvement in vision, “said Dr. McDonald “And its safe – incredible safe. That’s due to the fact that these radiofrequency waves do not remove any tissue from the eye, there’s no cutting and that, we think, makes it a very attractive option for millions of patients”

The refractive Viewpoint™ CK System received premarket approval for the temporary reduction of spherical hyperopia in patients who have 0.75 D to 3.25 D of cyclopegic spherical hyperopia, with less than or equal to 0.75 D of refractive astigmatism (minuse cylinder format), and a a cyclopegic spherical equivalent of 0.75 D to 3.00 D. Patients must be 40 years of age or greater with a documented stability of refraction for the prior 12 months , as demonstrated by a change of less that 0.50 D in spherical and cylindrical components of the manifest refraction.

The maginitude of correction with this treatment diminishes over time, with some patients retaining some or all of their intended refraction.

The magnitude of correction with this treatment diminishes over tie, with some patients retaining some or all of their intended refractive correction.

The immediate market application for CK is substantial and growing according to Mitchell B. Campbell, president of refractec. “As many as 40 million Americans are estimated to be over age 40 with low to moderate hyperopia (+0.75 to 3.00 diopters), the approved indication for CK. And, when you consider that very few of the nearly 2 million refractive procedures are performed to help farsighted patients, you can see the huge potential for CK.
These patients are looking for a procedure that they think is safe and easier to undergo and at present CK is the only alternative to laser,” said Campbell.

About Refractec
Refractec Inc. is a privately held ophthalmic company that develops and markets new ways for ophthalmologists to effectively treat refractive errors with its proprietary Conductive KeratoplastySM (CKSM) technology. Refractive is “Reshaping Vision Correction™ and changing patient outcomes. The company is headquartered at 5 Jenner Suite 150, Irvine, Calif.
Patients can visit (www.refractec.com) or call 1-800-752-9544 for more information on CK and to obtain a list of physicians nationwide offering the procedure.