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Conductive Keratoplasty Shows Similar Safety and Efficacy to LASIK in Treatment of Hyperopia: Presented at AAO

By Deanna M Green, PhD

ANAHEIM, CA -- November 21, 2003 -- Conductive Keratoplasty (CK) is a highly effective and safe procedure for the correction of hyperopia that shows comparable results to LASIK outcomes at two years, according to findings presented here November 17^th at the American Academy of Ophthalmology's 2003 Annual Meeting.

CK is a thermal keratoplasty procedure that uses radiofrequency energy to heat and reshape the cornea. It is a simple, quick, laserless procedure that rivals the use of LASIK in corrective surgery.

CK was recently approved for the treatment of spherical hyperopia at 0.75-3D in patients over the age of 40. More data are needed, however, regarding the long-term outcome of hyperopic patients who choose CK.

To that end, Marguerite B McDonald, MD, FACS, at Tulane University, New Orleans, United States, reported two-year results from a U.S. clinical trial designed to evaluate the safety and efficacy of CK in patients with hyperopia.

The multicentre study included 233 patients (mean age, 55) with hyperopia. CK was performed on 401 eyes with a spherical hyperopia of.75-3D and a <0.75D cylinder. Visual acuity (VA), spherical refraction, and safety parameters were assessed at 24 months.

Overall, the results met or exceeded the FDA target in both uncorrected VA and mean refractive spherical equivalence (MRSE) at three months and beyond. Specifically, 54% of patients had an uncorrected VA of 20/20 or better. This rate is comparable to that seen in laser-based procedures -- 59% for Technolos and 49% for LADAR Vision.

Furthermore, an MRSE of ±0.5D was met in 50% of patients, and an MRSE of ±1.0D was met in 82%. No significant refractive changes occurred over time, though a mean 0.31D was lost from one to two years post-operatively. Notably, this procedure was more stable than the refractive change seen after LASIK.

CK also had an excellent safety profile. Only 1% of patients lost two lines of best-corrected VA, and only one patient (0.29%) lost more than two lines of vision. This is significantly better than the two-line loss reported for LASIK (2.9%) and hyperopic photorefractive keratectomy (6.8%). At two years, 91% of patients were "neutral" to "very satisfied" with the procedure, and 95% noted improvement in vision quality.

"CK for the treatment of hyperopia is highly effective based on two-year follow up and is comparable to hyperopic LASIK," concluded Dr. McDonald. She further adds that "CK is safe, with a low rate of induced complications."


[Study title: Two-Year Cohort Results of a Multicenter U.S. Clinical Trial on Conductive Keratoplasty for Correcting Hyperopia. Abstract PA042]

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