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PA Asbell; One-Year Results of a Multi-Center, United States Clinical Trial on Conductive Keratoplasty (CK) for Correcting Hyperopia . Invest. Ophthalmol. Vis. Sci. 2002;43(13):4126.
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Purpose: Determine the 12-month efficacy and stability results of an FDA Phase III study of CK used to eyes for low to moderate hyperopia. Methods: Conductive keratoplasty is a technique that delivers radio frequency current directly into the corneal stroma. A Keratoplast Tip is inserted into the peripheral cornea at 8 to 32 treatment points to shrink collagen and produce a "cinching" effect that increases the curvature of the central cornea, thereby decreasing hyperopia. A total of 233 patients (390 eyes) with a mean preoperative MRSE of +1.82 ± 0.60 D and a peripheral pachymetry reading at the 6 mm optical zone no less than 560 microns were enrolled into the study at 13 US centers, underwent CK treatment, and were followed for one year. Total follow-up will be two years. Results: At one-year (N=171), 51% had postoperative UCVA 2020 or better, 73% had 20/25 or better, and 91% had 20/40 or better. The MRSE was within ±0.50 D in 58% and ±1.00 D in 91%. The refraction appeared to stabilize at six months, with a mean change in MRSE refraction of 0.26 D between three and six months, 0.09 D between six and nine months and 0.13 D between nine and 12 months. Conclusion: One-year data show excellent efficacy and stability of conductive keratoplasty in the treatment of hyperopia. The refractive effect appeared to stabilize at approximately six months.
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