Refocus Group'sPresVIEW™ Scleral Implants
are an
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What is Happening to My Eyes?
From birth, the natural crystalline lens has the
ability to focus, allowing us to see clearly at both near and far
distances. As we view
objects near to us, the lens natural focusing movement occurs within a defined
fixed space, with a set working distance between the lens and the muscles surrounding
the lens. The proper
distance between the lens and muscles allows the lens to change shape (see
figure 1).
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| Figure 1 |
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However, as we age, our lens grows in size at about the rate
of 20 microns per year and the working distance between the muscles and the
lens diminishes substantially, impairing the ability of the muscles to
manipulate the shape of the lens.
By our mid to late 40’s all ability to focus with the lens is lost, even
though the muscles themselves retain their original strength.
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| Figure 2 |
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PresVIEW™ Scleral Spacing Procedure
PresVIEW™ Scleral Spacing Procedure, a new technology for improvement of near vision is now available to selected patients in controlled clinical trials in Europe, (where the products are CE marked), and in the USA, where we are now enrolling patients in FDA Phase III clinical trials.
The PresVIEW™ Scleral Spacing Procedure involves the placement of four tiny implants into the sclera, the white part of the eye, (See figure 3). The implants, about the size of a small grain of rice, are clear plastic, and are therefore almost invisible after the surgery, once full healing has occurred (usually in 3-4 weeks).
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| Figure 3 |
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PresVIEW™ Scleral Implants are
placed in small "tunnels" in the sclera, created by our automated
precision instruments. This causes the sclera to stretch outwardly,
tightening the tiny fibers (zonules) that hold and manipulate the
crystalline lens. (See figures 4 and 5). This
stretching provides restored leverage for the ciliary muscles, causing
the crystalline lens to change shape when the ciliary muscle contracts
during accommodation, as the lens did when the patient was younger. This allows the lens to focus dynamically again with a variable range of near vision. Continuing
improvements are often seen up to twelve months after the SSP surgery,
as the muscles are strengthened after years of non-use. Reading print, computer screens, or any other near vision task may now be possible.
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| Figure 4 |
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Unlike other laser and non-laser surgeries for vision correction, the PresVIEW™ Scleral Spacing Procedure does not remove any tissue or compromise the center of the visual axis of the cornea or lens of the eye. This accounts for its excellent safety record.
In every monitored clinical trial to date, there have been no complications resulting in long-term vision impairment or loss of distance vision in any patient. Plus the PresVIEW™ Scleral Spacing Procedure is reversible if necessary, since the implants can be easily removed for any reason.
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| Figure 5 |
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