Treatment of Presbyopia With Conductive Keratoplasty(R): Six-Month Results of the 1-Year United States FDA Clinical Trial.

摘要

PURPOSE: To provide 6-month results of a 1-year clinical trial evaluating conductive keratoplasty (CK) for the treatment of presbyopic symptoms in emmetropic and hyperopic eyes. METHODS: A total of 143 patients with presbyopic symptoms were enrolled in this 1-year United States FDA clinical trial and treated to improve near vision in 1 eye (unilateral treatment). In addition, 33 fellow eyes were treated to improve distance vision (bilateral treatment). For near vision correction, the target refraction was up to -2.0 D in the nondominant eye, and for distance vision correction, 0.0 D. Enrolled patients had a preoperative spherical equivalent of plano to +2.00 D, no more than 0.75 D of refractive astigmatism, and were 40 years of age or older. No retreatments were performed. RESULTS: Of the eyes treated for near, 77% had uncorrected near vision of J3 or better at 6 months postoperatively. A total of 85% of all patients had binocular distance UCVA of 20/25 or better along with J3 or better near, a combination that represents functional acuity for a presbyope. Sixty-six percent of eyes treated for near had a manifest refractive spherical equivalent (MRSE) within +/- 0.50 D of intended at 6 months. In 89% of eyes, the MRSE changed 0.05 D or less between 3 and 6 months postoperatively. After month 1, the incidence of variables associated with safety was 1% or lower. Seventy-six percent were very satisfied or satisfied with their procedure. CONCLUSIONS: CK appears to be very safe and effective in producing functional visual acuity in presbyopic eyes up to 6 months following the procedure. Patient satisfaction with the procedure is similar to that of monovision LASIK.