Refocus Group, Inc.

PresVIEW™ and Presbyopia - For Patients

Refocus Group's Mission is to Become a Surgical Standard of Care for the Treatment of Presbyopia Worldwide

Note: The company’s primary product, the PresVIEW™ Scleral Implant  is an investigational device and is not approved for sale or use in the United States or Canada. However, the product is currently approved for sale in the European Union.




Presbyopia Impacts Nearly Everyone Age 40 And Beyond



As nearly everyone who is over the age of 40 knows, our eyes' ability to focus on close-up tasks such as reading diminishes as we age. This condition, known as presbyopia (Greek for "old eye"), eventually affects nearly all of the population past middle age. Historically, the only help for presbyopia has consisted of bifocal or other types of lenses, including reading glasses — and the exact cause of the condition remains complex and somewhat controversial.

How Do I Know If I Have Presbyopia?

As a small child at 10 years of age you were able to focus on small objects or print 2 inches from your eyes. At 30 years of age the same object needed to be placed at least 6 inches away in order to see it clearly. When reaching your mid-40's a focusing range of 12-16 inches or longer may be required. By the age of 50, if you are like most people, there is no distance, near or far, that will allow you to see newspaper print or small objects clearly.

You may have Presbyopia if you find your corrected distance vision is still good however:

    •    You have a tendency to hold reading materials at your arm's length
    •    Your vision is blurred at close-up ranges
    •    You're over 40 and experiencing eyestrain and fatigue while doing close work
    •    Magnifying or reading glasses become a necessity for visual tasks
         (i.e. reading or sewing)

What Causes Presbyopia?

Presbyopia occurs due to a loss of accommodation, the eye's ability to shift focus from distant to near.  There are several theories regarding the cause of accommodative loss. One predominate theory that has existed for over 150 years describes how the crystalline lens of the eye (located inside your eye, just behind the iris), becomes hardened and loses flexibility with aging. It was thought that since skin ages and becomes less elastic, the lens of our eye would do the same. Sometimes referred to as lens sclerosis, this theory was developed by Dr. Helmholtz in 1855 and is still generally accepted by about 50% of eye care professionals.

In the early 90’s another theory was developed by scientists working for Presby Corp. (the predecessor to Refocus Group) that refutes the hardening lens axiom. Thanks to this research our understanding of lens accommodation has changed. The research provided compelling evidence that the lens does not lose its flexibility, nor does the ciliary muscle (which contracts to manipulate the lens) grow weaker with age.  Instead the human lens continues to grow concentrically (approximately 20 microns per year) –  similar to the tissue in your skin or fingernails . This growth, in time, begins to crowd the space between the lens and the ciliary muscle. The result is a progressive reduction in the effective function of the ciliary muscle that leads to loss of accommodation.

Can Presbyopia Be Treated?  Are There Safe Alternatives?

The treatment for presbyopia may include reading glasses, bifocals, trifocals or contact lenses.  All of these solutions are safe, although many individuals consider them to be inconvenient.  Typically a person with reading glasses will have multiple pairs at home and at work.  Contact lens require a certain amount of maintenance and often have to be replaced.  Because presbyopia could complicate other common vision conditions like nearsightedness, farsightedness and astigmatism, your doctor will perform other tests to determine the specific lenses that would allow you to see clearly at near.

One available alternative is using a monovision approach, correcting one eye for distance vision and the other eye for near vision using a contact lens or an Excimer Laser (LASIK) procedure.  There is also a method to reshape one of the corneas using high frequency radio waves to achieve the same effect.  Not everyone can tolerate monovision since it requires an adjustment period, but many find this approach a satisfactory solution.  Also, in the case of the LASIK or high frequency radio waves, the change to the cornea is permanent and can not be reversed.

There are also other options frequently recommended including removal of the crystalline lens and replacement with an artificial lens with multiple optic zones (both near and far – known as a “multi-focal” lens) or with a flexible lens that provides a small amount of dynamic near vision (known as an “accommodating” lens).  These are often good solutions for cataract patients who have lost most of or all of their ability to see near or far.    However, for the non-cataract patient, distance vision could be reduced by both multi-focal and accommodating lenses, and halos and night glare are often reported.  In addition, there is a slight risk that removal of the natural lens could result in complications in the process of replacing it with an artificial lens.  With the exception of glasses or contact lens, all of the above procedures are permanent and can not be reversed once the procedure is completed.

Refocus Group Pursues Presbyopia With An Innovative Treatment Option: The PresVIEW™ Scleral Spacing Procedure

Unlike other presbyopia solutions, our PresVIEW™ Scleral Spacing Procedure, ("SSP"), was developed to re-establish the natural tissue spacing surrounding the crystalline lens - enabling the restoration of the eye's natural accommodation using the same mechanisms employed when you were young.   This patented technique involves placing four small pieces of inert plastic in a circular arrangement in the white part of the eye (the sclera). The small implants expand the underlying muscle, which can then better manipulate the lens, restoring the ability of the eye to focus at multiple distances.   This revolutionary procedure was developed by scientists working for Presby Corp in the 1990’s, and is currently being tested in FDA trials in the U.S.

The procedure is minimally invasive and designed to be completed by trained physicians on an outpatient basis in about 20-30 minutes per eye using topical and/or local anesthesia.   Because the surgery occurs in the sclera (the white of the eye), it does not alter the cornea or the crystalline lens in any way and there are few of the potential risks associated with intraocular surgery.     After the eye fully heals from the surgery (about three – four weeks), the implants are largely invisible from a cosmetic perspective.    Although rare, should the patient be dissatisfied in any way, the implants can easily be removed.     We believe that the PresVIEW™ Scleral Spacing Procedure is safe and that no permanent alteration to the eye will occur cosmetically or functionally once the implants are removed.  However, as with all surgical procedures, some risk of an adverse event is always present.  Your doctor can advise you regarding the specific risks and the safety profile of the SSP procedure.

Participants in clinical trials conducted by Refocus Group have reported improved near vision generally no later than 1 to 4 weeks following the procedure, and a large percentage of patients are able to read without glasses or other visual aids by the end of this time.   Because the PresVIEW™ Scleral Spacing Procedure is designed to restore the natural use of the muscles, as the muscles grow stronger, near vision will often continue to improve up to twelve months after the surgery.   As importantly, near vision is restored by providing a dynamic range of near acuity, with no glare or halos, no loss of contrast sensitivity (the ability to distinguish shades of grey),  and no potential loss of distance vision.

Availability

In the United States, Refocus Group has completed the first phase of feasibility clinical trials in accordance with Food And Drug Administration (“FDA”) regulations.   Subsequently, Refocus received FDA approval for expanded clinical trials as part of the process required for eventual market approval in the U.S.   Internationally, the PresVIEW Scleral Spacing Procedure has received the CE Mark certification in the European Union, and is anticipated to be available for commercial use in the European Union in 2010.