Laser in situ keratomileusis for spherical hyperopia and hyperopic astigmatism using the NIDEK EC-5000 excimer laser

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.

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.

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.

The NIDEK EC-5000 corrected hyperopia and hyperopic astigmatism with UCVA, refractive accuracy, 1-year stability, and safety that surpassed all FDA criteria.