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ViewPoint CK System (Conductive Keratoplasty)

ProductsViewPoint CK System (Conductive Keratoplasty)
Company Refractec, Inc.
Item ViewPoint CK System (Conductive Keratoplasty)
Features Presbyopic Indications
Approval of the premarket approval application supplement for the Refractec ViewPoint CK System is for the temporary induction of myopia (-1.00 D to -2.00 D) to improve near vision in the non-dominant eye of presbyopic hyperopes or presbyopic emmetropes, via spherical hyperopic treatment of 1.00 D to 2.25 D, in patients 40 years of age or greater with a documented stability of refraction for the prior 12 months, as demonstrated by a change of < 0.50 D in spherical and cylindrical components of the manifest refraction, and with = 0.75 D of cycloplegic refractive cylinder and with a successful preoperative trial of monovision or history of monovision wear (i.e., dominant eye corrected for distance vision and non-dominant eye corrected for near vision).

Hyperopic Indications
The Refractec ViewPoint CK System is for the temporary reduction of spherical hyperopia in patients who have 0.75 D to 3.25 D of cycloplegic spherical hyperopia, less than or equal to 0.75 D of refractive astigmatism (minus cylinder format), and a cycloplegic 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 than 0.50 D in spherical and cylindrical components of manifest refraction. The magnitude of correction with this treatment diminishes over time, with some patients retaining some or all of their intended refractive correction.

Description NearVision™ CK is the only procedure designed for patients with a spherical hyperopia between +0.75 D and +3.00 D or presbyopic patients who would benefit from a spherical treatment of between 1.00 D and 2.25 D to achieve a myopic endpoint of between -1.00 D and -2.00 D in their non-dominant eye to temporarily improve near vision. CK is unique in that it uses radiofrequency (RF) instead of a laser. It takes as little as three minutes and can be conveniently performed in-office using the ViewPoint CK System.

NearVision CK builds upon the principles of thermokeratoplasty, using radiofrequency (RF) energy to temporarily reshape the cornea and therefore adjust its refractive characteristics.

RF energy and its application
To perform the procedure, a handpiece with a Keratoplast™ Tip delivers controlled RF energy directly to the internal corneal tissue in a ring pattern. The tip serves as an RF antenna while the speculum holding the eye open serves as the return path. By applying RF energy to the tissue, Ohm's law (V = I R) defines a consistent relationship that determines the heat generated. The voltage (V) determines the electrical field strength within the tissue while the current (I) is defined by the treatment parameters. Impedance is a characteristic of tissue.

The characteristics of the energy (i.e., current, waveform, frequency, rep rate and crest factor) and the tissue's consistent conductive properties make it possible for CK to achieve a reproducible, optimal tissue temperature for the critical time necessary to bring about the localized shrinkage of the collagen fibers.

Depth of procedure and effects
CK creates a purse-string effect that steepens the central cornea through a ring of application spots around the periphery of the cornea. Several studies have concluded that the depth of shrinkage determines the degree of corneal correction permanency. Because of the intrastromal delivery of RF energy, CK produces collagen shrinkage that encompasses 80% of the corneal thickness.

Info Refractec, Inc.
Customer Service: (800) 752-9544
Web site: http://www.refractec.com

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