Treatment of presbyopia with conductive keratoplasty: six-month results of the 1-year United States FDA clinical trial.

Abstract:

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.

journal_name

Cornea

journal_title

Cornea

authors

McDonald MB,Durrie D,Asbell P,Maloney R,Nichamin L

doi

10.1097/01.ico.0000126321.13143.a0

subject

Has Abstract

pub_date

2004-10-01 00:00:00

pages

661-8

issue

7

eissn

0277-3740

issn

1536-4798

pii

00003226-200410000-00003

journal_volume

23

pub_type

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