Thermokeratoplasty

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ViewPoint™ CK System (Conductive Keratoplasty)

Refractec, Inc.

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.
System components: Radiofrequency energy console
Energy source for the procedure, which is activated only by a treatment card.
Corneal marker
Used to mark the cornea to specify the treatment pattern.
Lid speculum
Attached by a cable and connector to the console, this tool serves as the return (dispersive) electrode for the RF energy being delivered through the Keratoplast™ Tip. Two types of specula are offered: the small wire type and the locking type for patients in a supine position or when the procedure is being performed under an operating microscope.
Handpiece
A reusable, pen-shaped instrument that connects with the Keratoplast Tip. Also attached to the console by a cable and connector.
Keratoplast tip
A single-use, micro-thin tip that is 90 µm in diameter and 450 µm long, and is attached to the handpiece that delivers the RF energy directly to the corneal stroma. This sterile tip also has a plastic stop at the very distal portion to assure the correct penetration depth.
Footpedal control
A familiar and easy-to-use activation pedal for the controlled release of radiofrequency energy