Long-term Results of Combined LASIK and Monocular Small-Aperture Corneal Inlay Implantation.

PURPOSE: To evaluate the long-term effectiveness and safety of combined LASIK and small-aperture intracorneal inlay implantation (KAMRA; AcuFocus, Irvine, CA) for the surgical compensation of presbyopia and refractive errors. METHODS: Retrospective chart review of all ametropic, presbyopic patients who underwent combined LASIK and KAMRA inlay implantation at a single clinic. Demographic data and preoperative uncorrected and corrected monocular and binocular near and distance visual acuity (UNVA, UDVA, and CDVA) with manifest refractive spherical equivalent (MRSE) were collected and analyzed. All perioperative adverse events were recorded. RESULTS: In total, 132 patients were available (median age: 56 years; interquartile range (IQR) ± 5; range: 44 to 68 years). Median preoperative MRSE was +1.37± 1.20 diopters (D). The majority (113; 85%) were hypermetropic. Preoperative median UNVA improved from N24 (J13) ±6 to N6 (J5) ±1 by day 1 postoperatively, remaining stable throughout follow-up. At last follow-up, 97% of patients achieved UNVA of N5 (J3) or better. Median UDVA (implanted eye) improved from 20/40 (0.50 ± 0.41 on the decimal chart) preoperatively to 20/25 (0.80 ± 0.13) at month 12. Binocular UDVA was 20/20 in 88%, with CDVA unchanged for 84% at 12 months. No patient lost more than one line of CDVA. MRSE was also stable, albeit +0.25 D off-target refraction (-0.75 D). Two inlays were explanted due to suboptimal adaptation/corneal haze. CONCLUSIONS: The results of this follow-up study show that combined insertion of a small-aperture corneal inlay with LASIK in presbyopic patients improves near vision with a slight compromise in distance vision in the implanted eye. Overall, it appears to be a safe, effective procedure for the treatment of presbyopia. [J Refract Surg. 2016;32(6):379-384.].