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CK (Conductive Keratoplasty)
FDA Approves First & Only Vision Technology For Presbyopic Baby Boomers: The Viewpoint™ CK System for NearVision CK (Conductive Keratoplasty)
NearVision CK Improves NearVision and is Sole Procedure for the Millions Who Want Freedom from Reading Glasses
America's Most Prevalent Eye Condition: 90 Million Have or Will Soon Develop Presbyopia
Irvine, CA, March 22, 2004 - Ophthalmic device manufacturer Refractec Inc. announced today that the U.S. Food and Drug Administration (FDA) has granted approval of the ViewPoint CK System for performing the NearVision CK (Conductive Keratoplasty) procedure. It is the first and only FDA-approved vision technology that improves near vision in the millions of Baby Boomers with presbyopia, the age-related eye condition that sets in after age 40. NearVision CK uses radio waves to reshape the cornea and bring near vision back into focus. Minimally invasive and painless, NearVision CK is performed in less than three minutes in the doctorÕs office with only eye-drop anesthesia. The procedure is laser-free and extremely safe; there is no cutting and no removal of tissue.
The Greek word for "aging eye," presbyopia is the most prevalent eye condition in America, affecting most people after age 40 and everyone by age 51. Presbyopia causes near vision to fade with age, making it difficult to see things up-close. An estimated 90 million Baby Boomers either have presbyopia or will develop the condition in the next 10 years. These people struggle to read or do hobby work and must rely on magnifying reading glasses for even the most mundane of daily tasks, like checking their watch. They often own multiple pairs of reading glasses (called "readers," "half-eyes" or "granny glasses"), which many consider a hassle and an unwelcome sign of aging.
"Presbyopia is the one inescapable vision disorder that will eventually affect us all," said Daniel S. Durrie, M.D. associate clinical professor, University of Kansas and medical monitor for the FDA clinical trial of presbyopia. "The frustration many people feel with the on-again, off-again annoyance of reading glasses cannot be overemphasized. NearVision CK is just what Baby Boomers have been waiting for to help them get rid of their reading glasses and safely see like they did when they were young."
Procedure Custom-Made For Baby Boomers
NearVision CK is the only vision procedure designed specifically for Baby Boomers who want a safe, minimally invasive procedure to free them of reading glasses. CK has become the fastest-growing new refractive procedure since the introduction of LASIK according to research firm Market Scope. More than 30,000 CK procedures have been performed since the FDA first approved it in 2002 for age-related farsightedness (hyperopia), a condition that differs from presbyopia in its effect on the eye's ability to focus, but has similar symptoms.
The FDA based its approval on clinical trial data collected at the 12-month follow-up visit in which NearVision CK demonstrated effectiveness in significantly improving patients' near vision.
- 98 percent of patients could see J5 (magazine- and newspaper-size print) in the eye that was treated
- 87 percent of patients could see 20/20 in the distance and also read J3 or phonebook-sized print (significantly smaller than news print).
- There were NO reported serious, sight-threatening or unanticipated safety events.
"During the clinical trials, everyone we treated had an improvement in near vision," said Marguerite B. McDonald, M.D., clinical professor of ophthalmology at Tulane University, director of the Southern Vision Institute, New Orleans, La., and medical monitor for Refractec, Inc. "Doctors and patients alike are excited about the safety and simplicity of the procedure. NearVision CK has the potential to expand the refractive market and for the first time, help millions of Americans improve their near vision."
About NearVision CK
NearVision CK is performed using a probe thinner than a strand of hair that releases radiofrequency energy. Applied to the cornea in a circular pattern, the radio waves shrink small areas of collagen to create a constrictive band (like the tightening of a belt) that increases the curvature of the cornea, bringing near vision back into focus.
NearVision CK is indicated for the temporary improvement of near vision in emmetropic presbyopes (those who require only reading glasses) and hyperopic presbyopes (those who require reading and distance glasses). The procedure is typically performed on just one eye, improving near vision without compromising the patient's binocular distance vision.
About NearVisionSM CK
NearVision CK (Conductive Keratoplasty) truly represents a significant advancement in vision improvement technology. Developed specifically for patients over 40 who are tired of their reading glasses, NearVision CK has proven to be a safe and effective alternative to laser surgery. In fact, NearVision CK is performed using the only technology approved by the FDA for improving near vision in baby boomer patients - the ViewPoint™ CK System.
What is NearVision CK?
NearVision CK (Conductive Keratoplasty ) can change how the eye focuses light by reshaping the cornea to improve near vision. It uses a controlled release of radiofrequency (RF) energy to shrink corneal tissue, which steepens the cornea. This steepening creates a safe and predictable modification to the topographical (surface) curvature of the cornea for the temporary reduction of presbyopic and hyperopic symptoms.
Did you know?
Conductive Keratoplasty isn't the only use of radiofrequency (RF) energy in medicine. Doctors have been safely using this technology in surgery since the 1950s.
Is NearVisionSM CK Right for Me?
NearVision CK (Conductive Keratoplasty) is intended for people over the age of 40 who need reading glasses (clinically termed "presbyopia") and people with farsightedness (clinically termed "hyperopia"). CK is not intended for people with nearsightedness (clinically termed "myopia"). All patients considering vision improvement should undergo a complete examination by a doctor prior to the procedure.
You're likely a good candidate for NearVision CK if you:
- Are over age 40
- Had great vision your whole life
- Require reading glasses to compensate for fading near vision
How Does NearVisionSM CK Work?
If you've been afraid of surgery, but still want to temporarily reduce your dependence on reading glasses or other corrective lenses, NearVision CK (Conductive Keratoplasty) may be the right choice for you. It's a quick procedure with no cutting involved. You don't even have to go to an outpatient surgery center. It can be performed in as little as three minutes in your doctor's office.
How the procedure is performed
NearVision CK uses a pen-shaped instrument with a cool tip as thin as a human hair. After application of anesthetic eye drops, your doctor will apply radiofrequency (RF) energy in a circular pattern. This pattern is applied in the periphery of the cornea and therefore minimizes interference with your line of sight. A device called a "speculum" is inserted to hold your eye open during the procedure.
NearVision CK is considered painless. Once finished, you don't have to wear a patch and can usually return to work the next day. During the first 24 to 48 hours after the procedure, you may experience some mild discomfort, including a foreign-object sensation or "scratchiness" in the eye. Vision begins improving in about a week's time.
The results
NearVision CK modifies the topographical (surface) curvature of the cornea, making it temporarily steeper and improving near vision. In FDA clinical studies, 98% of patients were able to read newspaper-size print without reading glasses after the CK procedure (12-month follow-up data).
Frequently Asked Questions
How is NearVision CK performed?
NearVision CK uses radio waves, instead of a laser or scalpel, to reshape the cornea and bring near vision back into focus. NearVision CK is performed using a small probe, thinner than a strand of human hair, that releases radio waves. The probe is applied in a circular pattern on the outer cornea to shrink small areas of collagen. 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. NearVision CK is performed without the cutting or removal of tissue. It is a safe, minimally invasive procedure for baby boomers that struggle to read a newspaper, menu, alarm clock or computer.
Is radiofrequency (RF) energy safe for use on the eye?
Yes. The use of RF energy is one of today's most advanced surgical techniques. In addition to its use in NearVision CK, RF technology is being used in prostate cancer therapy, back surgery, even cardiovascular procedures.
Will my vision improve immediately after the NearVision CK procedure?
Patients usually notice an immediate improvement in their vision after the NearVision CK procedure. However, it usually takes several weeks for the eyes to adjust to the final level of treatment.
Will my vision fluctuate after NearVision CK is performed?
Most patients will experience mild fluctuation in their vision after the procedure, but few notice it. Any fluctuation will usually subside within a few weeks. Patients, who have a procedure to steepen the cornea (presbyopia or hyperopia), regardless of the procedure, usually require a longer stabilization period than those who receive a treatment that flattens the cornea (myopia).
Are both eyes treated on the same day?
NearVision CK is typically performed on just one eye. However, if a patient's prescription requires 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 procedure is minimally invasive, takes less than three minutes and is done in-office with only topical anesthesia.
Will I have to wear patches over my eyes after the NearVision CK procedure?
You will not have to wear patches or bandages.
How soon can I return to work?
With NearVision CK, the majority of patients are able to return to work and other normal activities the day after 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 of vision (such as dentistry, surgery or computer work) may want to give their eyes some extra rest for several days following the procedure before going back to work.
What type of anesthesia is used during the NearVision CK procedure?
A local anesthetic in the form of eye drops is used to numb the eye. Those patients who are nervous or have a high level of anxiety will be given a mild sedative to help them relax.
What will I feel during the NearVision CK procedure?
The NearVision CK procedure is considered painless. You will be aware of a support (speculum), which helps to hold your eye open. The most common sensation that patients experience is a feeling of pressure on the eye. After the procedure, there may be some mild discomfort, and many patients experience a foreign-object sensation or "scratchiness" in the eye. This usually subsides within 24 hours of the procedure.
Why doesn't NearVision CK use a laser?
NearVision CK is a non-laser procedure that uses controlled radio waves to improve near vision. Rather than removing tissue with a laser, NearVision CK reshapes the cornea using an entirely different method: the application of low-level, radiofrequency (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 and temporarily improve near vision. The procedure, which takes less than three minutes, is done in-office with only topical anesthesia (eye drops).
Will the instrument used in the NearVision CK procedure penetrate my cornea?
NearVision CK is performed using a probe (Keratoplast™ Tip) that is as thin as a strand of human hair. The probe, introduced into the cornea, applies controlled radiofrequency (RF) energy, stabilizes the CK procedure and guarantees the precise depth of treatment.
How is a precise amount of radiofrequency (RF) energy and depth of treatment ensured during the NearVision CK procedure?
The technology used during the procedure was engineered and designed specifically for performing NearVision CK. This means that 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 450 µm and utilizes a plastic stop at the very distal portion to assure precise depth of penetration.
What are the risks and side effects of NearVision CK?
Because NearVision CK is minimally invasive, the procedure has exhibited very minimal risk and almost no side effects. During the first 24 to 48 hours after NearVision 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 NearVision CK doesn't cut or remove tissue, many of the side effects associated with other vision treatment procedures have not been observed with NearVision CK.
Are there restrictions after having NearVision CK?
As with any vision treatment procedure where the cornea is altered, certain precautions should be taken. After the NearVision 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 a week after the procedure. Also, patients should avoid rubbing their eyes vigorously for two weeks following the procedure. Females should also avoid applying eye makeup for one week after the procedure.
Am I guaranteed 20/20 vision following NearVision CK?
No. And no honest doctor can absolutely guarantee a certain result from any vision treatment procedure. However, in the FDA clinical study, nearly 87% of patients had 20/20 vision while looking at objects in the distance and were able to read phonebook-size print (J3) after having NearVision CK (12-month follow-up data).
Is NearVision CK reversible?
As with most vision improvement procedures, NearVision 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 undergoing a vision procedure to carefully consider. To make sure NearVision CK is right for you, seek the advice of your doctor.
Will my health insurance cover the cost of the NearVision CK procedure?
Because NearVision CK is considered elective surgery (cosmetic), most health insurance plans do not cover it. Financing options are available to make NearVision CK more affordable. For more information about financing, ask your doctor.
Who is NearVision CK right for?
You're likely a good candidate for NearVision CK if you:
- Are over age 40
- Had great vision your whole life
- Require reading glasses to compensate for fading near vision
This is not a complete list of indications and contraindications.
Can NearVision CK treat myopia (nearsightedness)?
NearVision CK was designed for baby boomers who struggle to read menus, price tags or see their computer - symptoms of fading near vision which require a steepening of the cornea. NearVision CK is not designed to flatten the cornea, the effect required for the treatment of myopia.
Can NearVision CK be performed on patients who have a pacemaker?
The NearVision CK equipment can produce interference that may adversely influence the operation of other electronic equipment. Therefore, NearVision CK is contraindicated for patients who are wearing a pacemaker.
What enables NearVision CK to be performed in-office?
Near Vision CK is a minimally invasive procedure that does not require cutting of the cornea, and therefore does not carry the associated risks or surgical complications. The procedure is relatively quick and easy to perform - taking an average of just 3 minutes.
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