First and Only FDA Approved Technology for Presbyopic Patients
The ViewPointTM CK System, used to perform NearVision CK, is the first and only FDA-approved refractive technology for improving the loss of near vision that accompanies presbyopia. LASIK isn't approved for it; neither are IOLs (intraocular lenses).
- NearVision CK has one of the highest safety profiles in the refractive market thanks to the use of controlled radio waves, instead of a laser or scalpel, that gently change the shape of the cornea to improve vision.
- In addition to its approved indications, CK is being studied in internationally for use post-laser surgery and for treating astigmatism.
Benefits at a Glance
NearVision CK is the first and only procedure specifically for Baby Boomers who want freedom from their reading glasses. NearVision CK:
- uses controlled radio waves, instead of a laser or scalpel, to change the shape of the cornea and bring near vision back into focus.
- is laser-free and extremely safe: There is no cutting and no removal of tissue.
- is minimally invasive and painless.
- is fast: The procedure is performed in under three minutes.
- is easy to undergo: It is performed in the doctor's office with only eye drop anesthesia.
You're a candidate for NearVision CK if you're
- over age 40;
- had great vision your whole life; and
- rely on reading glasses to compensate for the loss of near vision.
Market Growth
- NearVision CK has become the fastest-growing new refractive procedure since the introduction of LASIK according to research firm Market Scope.
- A 2003 survey by the American Society of Cataract and Refractive Surgeons reports that more than a third of U.S. ophthalmologists plan to offer NearVision CK, up from less than 10 percent in 2002.
- Presently, nearly 500 U.S. ophthalmologists are certified to perform NearVision CK.
- NearVision CK costs an average of $1,500 per eye. To date, nearly 30,000 CK procedures have been performed nationwide.
Presbyopia and Baby Boomers
- Presbyopia, Greek for 'aging eye,' is a progressive condition that causes near vision to fade with age.
- Presbyopia is the most prevalent eye condition in America. It affects most people by the age of 40 and everyone by the age of 51. An estimated 90 million American Baby Boomers either have presbyopia or will develop the condition in the next 10 years.
- Symptoms of presbyopia include difficulty with all forms of near vision, such as reading, ordering from a menu, checking a price tag, dialing a cell phone, or even doing hobby work. People affected by presbyopia often own multiple pairs of reading glasses and must rely on them for even the most mundane of daily tasks.
- Since their vision began to deteriorate later in life, many Baby Boomers consider the need for reading glasses (often called 'half-eyes,' 'readers' or 'granny glasses') an unwelcome sign of aging.
- A survey of Baby Boomers conducted by AllAboutVision.com, a consumer vision care resource, found that two-thirds of those surveyed would consider having an elective procedure to reduce their dependence on reading glasses. A full 42 percent ranked CK as their number-one choice, citing its non-invasive method and safety as the primary reasons for their preference.
Patients Report Significant Near Vision Improvement
- FDA clinical trial data collected 12-months after NearVision CK was performed show:
- 98 percent of patients could see J5 (magazine- and newspaper-sized print) in the eye treated, and
- 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.
NearVision CK Procedure
The NearVision CK System
- 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 typically performed on just one eye, restoring near vision without compromising the patient's binocular distance vision.
- 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).
Investors Show Confidence in NearVision CK
- To date, Refractec Inc. has raised approximately $35 million to fund the launch of CK.
- Investors include Putnam Investments (Boston, Mass.); The Entrepreneurs' Funds of R.B. Webber & Company (Mountain View, Calif.); Brentwood Venture Capital (Menlo Park, Calif.,); Delphi Ventures, Inc. (Menlo Park, Calif.); and Versant Ventures (Menlo Park, Calif.).