Articles about Eye Health and Disease 2004
 

CK (Conductive Keratoplasty) is Approved by the FDA for the Treatment of Presbyopia

(From Ocular Surgery News 2/9/04)


The ViewPoint CK System was recommended for approval, with conditions, by an advisory panel to the Food and Drug Administration. The Ophthalmic Devices Panel voted unanimously to recommend the system for approval for presbyopia (the loss of near vision with age corrected with reading glasses), The device was previously approved by the FDA in 2002 for use in hyperopia (farsightedness).  According to Refractec, the device’s marketer, the panel recommended approval of the ViewPoint system to perform conductive keratoplasty for the improvement of near vision in emmetropic presbyopes (those requiring only reading glasses) and hyperopic presbyopes (those who are farsighted and require reading glasses).

A minimally invasive procedure, NearVision CK uses radio waves to shrink small areas of collagen, creating a constrictive band that increases corneal curvature and brings near vision back into focus. It can be performed in less than three minutes in a doctor’s office with eye-drop anesthesia, and no tissue is cut or removed. The procedure is typically performed on just one eye to avoid compromising the patient’s binocular distance vision.

The panel’s discussion and recommendations were based on the results of a study with 12-month follow-up in which CK demonstrated effectiveness in “significantly improving a patient’s near vision,” according to a Refractec press release. At 1 year in the study, 95% of patients could see J5 (magazine- and newspaper-size print), and 83% of patients could see 20/20 and read J3 (very small print). There were no reported serious, sight-threatening or unanticipated safety events, according to Refractec. The panel agreed with Refractec that the intended range of correction for the presbyopic procedure should be 1 D to 2.25 D. The conditions imposed by the panel pertained to the device’s labeling. The panel stressed the importance of educating patients that the long-term effects of CK are unknown, and the effects of the procedure may be temporary. Refractec is to provide additional data in this area.

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