Dr. Stulting is a paid consultant to Alcon Laboratories, Inc., and was a medical monitor for the U.S. Food and Drug Administration (FDA) clinical trial. Dr. Fant is president of Clinical Research Consultants, Inc. (CRC), the clinical and regulatory consulting group that sponsored the FDA clinical trial. Dr. Fant and CRC were supported by Alcon Laboratories, Inc.

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<h4>PURPOSE</h4><p>To assess the efficacy, predictability, and safety of LASIK for the surgical correction of low to moderate hyperopia and hyperopic astigmatism using the NIDEK EC-5000 excimer laser.</p> <h4>METHODS</h4><p>In a multicenter United States Food and Drug Administration (FDA) regulated study of LASIK, 7 centers enrolled 293 eyes with manifest refraction sphere that ranged from +0.50 to +6.00 diopters (D) with or without astigmatism up to 3.00 D. The intended outcome was plano in all eyes. Patients were treated bilaterally. One year postoperative outcomes are reported. </p> <h4>RESULTS</h4><p>The mean spherical equivalent refraction (MRSE) for all eyes changed from +2.61±1.19 D (range: +0.50 to +6.63 D) preoperatively to +0.35±0.54 D (range: -1.63 to +2.00 D) 1 year postoperatively. Overall, 61% (170/279) of eyes achieved distance uncorrected visual acuity (UCVA) of 20/20 or better, 82% (228/279) of eyes saw 20/25 or better, and 99% (277/279) of eyes saw 20/40 or better. Refractive accuracy was demonstrated as 63.1% (176/279) of eyes achieved a MRSE within ±0.50 D and 90.3% (252/279) of eyes within ±1.00 D. Less than 2% (4/279) of eyes lost 2 lines of distance best spectacle-corrected visual acuity. Stability of refraction was demonstrated by 6 months, with a mean hyperopic shift of <0.03 D from 3 to 6 months. </p> <h4>CONCLUSIONS</h4><p>The NIDEK EC-5000 corrected hyperopia and hyperopic astigmatism with UCVA, refractive accuracy, 1-year stability, and safety that surpassed all FDA criteria. [<cite>J Refract Surg.</cite> 2008;24:123-136.]</p> <h4>ABOUT THE AUTHORS</h4> <p>From InView, Atlanta, Ga (Waring); Clinical Research Consultants Inc, Cincinnati, Ohio (Fant); Sound Eye and Laser, Seattle, Wash (Phillips); Fischer Laser Eye Center, Willmar, Minn (Fischer); Liberty Laser Eye Center, Vienna, Va (Tanchel); Southern Eye Associates, Memphis, Tenn (Schanzer); the Department of Ophthalmology, Loma Linda University, Loma Linda, Calif (Narvaez); and CODET/Aris Vision Institute, Tijuana, BC, Mexico (Chayet).</p> <p>Dr Waring is a consultant for NIDEK, AMO, Acufocus, Calhoun Vision, and SCHWIND. Dr Chayet is a consultant for NIDEK and Calhoun Vision. Dr Fant is a consultant for NIDEK and has a financial interest in Clinical Research Consultants Inc. The remaining authors have no financial interest in the materials presented herein.</p> <p>Correspondence: George O. Waring III, MD, InView, 301 Perimeter Center North, Ste 600, Atlanta, GA 30346. Tel: 678.222.5102; Fax: 404.250.9006; E-mail: <a href="mailto:drgeorge@georgewaring.com">drgeorge@georgewaring.com</a></p> <p>Received: June 25, 2007</p> <p>Accepted: December 4, 2007</p>

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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