Purpose: To report a retrospective study of simultaneous LASIK versus photorefractive keratectomy (PRK) with accompanying small-aperture cornea inlay implantation (KAMRA; AcuFocus, Inc., Irvine, CA) in treating presbyopia.
Methods: Simultaneous LASIK/inlay and simultaneous PRK/inlay was performed on 79 and 47 patients, respectively. Follow-up examinations were conducted at 1, 3, and 6 months postoperatively. The main outcome measures were safety, efficacy, predictability, and stability with primary emphasis on monocular uncorrected near visual acuity (UNVA).
Results: Both groups met U.S. Food and Drug Administration criteria for efficacy with 95% and 55% of the LASIK/inlay group and 83% and 52% of the PRK/inlay group having a monocular UNVA of 20/40 (J5) and 20/25 (J2), respectively, at 6-month follow-up. Ninety-two percent of the LASIK/inlay group and 95% of the PRK/inlay group had a UDVA of 20/40 or better at 6 months. Two eyes lost one line of corrected distance visual acuity (CDVA). Mild hyperopic shift was noted in both groups at 6 months.
Conclusions: Simultaneous PRK/inlay and LASIK/inlay meet the U.S. Food and Drug Administration standards for efficacy and safety based on 6-month preliminary results and have similar outcomes to emmetropic eyes. [J Refract Surg. 2018;34(5):310-315.].
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