Purpose: 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.
Methods: 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.
Results: The mean spherical equivalent refraction (MRSE) for all eyes changed from +3.51 +/- 1.45 [corrected] D (range: +0.50 to +6.63 D) preoperatively to +0.35 +/- 0.54 D (range: +1.63 [corrected] to +2.00 D) 1 year [corrected] 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.
Conclusions: The NIDEK EC-5000 corrected hyperopia and hyperopic astigmatism with UCVA, refractive accuracy, 1-year stability, and safety that surpassed all FDA criteria.
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