Retrospective Comparison of Visual Outcomes After KAMRA Corneal Inlay Implantation With Simultaneous PRK or LASIK

J Refract Surg. 2018 May 1;34(5):310-315. doi: 10.3928/1081597X-20180228-03.

Abstract

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.].

Publication types

  • Comparative Study

MeSH terms

  • Adult
  • Corneal Stroma / surgery*
  • Female
  • Humans
  • Keratomileusis, Laser In Situ / methods*
  • Lasers, Excimer / therapeutic use*
  • Male
  • Middle Aged
  • Photorefractive Keratectomy / methods*
  • Presbyopia / physiopathology
  • Presbyopia / surgery*
  • Prostheses and Implants
  • Prosthesis Implantation*
  • Refraction, Ocular / physiology
  • Retrospective Studies
  • Treatment Outcome
  • Visual Acuity / physiology*