Volume 34, Issue 11 , Pages 1862-1871, November 2008
Topographically guided laser in situ keratomileusis for myopia using a customized aspherical treatment zone
Purpose
To assess the efficacy, predictability, safety, and quality-of-life effects of topography-guided laser in situ keratomileusis (LASIK) for the correction of myopia with astigmatism using the EC-5000 CXII excimer laser equipped with a customized aspheric treatment zone algorithm.
Setting
Ophthalmology clinics in the United States and Mexico.
Methods
In a multicenter United States Food and Drug Administration study of topography-guided LASIK, 4 centers enrolled 135 eyes with a spherical manifest refraction error ranging from −0.50 to −7.00 diopters (D) and astigmatism ranging from 0.50 to 4.00 D. All eyes were targeted for emmetropia. Refractive outcomes, higher-order aberrations (HOAs), and contrast sensitivity were analyzed preoperatively and postoperatively. Patient satisfaction was assessed using 2 questionnaires.
Results
Six months postoperatively, the mean manifest refraction spherical equivalent in all eyes was −0.09 D ± 0.31 (SD); of the 131 eyes, 116 (88.55%) had an uncorrected visual acuity of 20/20 or better and 122 (93.13%) had an MRSE within ±0.50 D. The best spectacle-corrected visual acuity (BSCVA) increased by 2 or more lines in 21 (16.03%) of 131 eyes; no eye lost 2 lines or more of BSCVA. The total ocular HOA increased by 0.04 μm. Patients reported significantly fewer night driving and glare/halo symptoms postoperatively than preoperatively.
Conclusion
Use of a customized aspherical treatment zone in eyes with myopia and astigmatism was safe, effective, and predictable and reduced symptoms associated with night driving, glare, and halos.
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Dr. Dougherty is a consultant to Nidek Co. Ltd., Alcon, Lenstec, and Allergan. Dr. Waring is a consultant to Nidek Co. Ltd., Advanced Medical Optics, Acufocus, Calhoun Vision, and ARCLaser. Dr. Chayet is a consultant to Nidek Co. Ltd. and Calhoun Vision. Mr. Bains is a clinical consultant to Nidek Co. Ltd. Dr. Fant is president and CEO of Clinical Research Consultants, Inc.
PII: S0886-3350(08)00824-9
doi:10.1016/j.jcrs.2008.07.021
© 2008 ASCRS and ESCRS. Published by Elsevier Inc. All rights reserved.
Volume 34, Issue 11 , Pages 1862-1871, November 2008
