Five-Year Results of Combined Small-Aperture Corneal Inlay Implantation and LASIK for the Treatment of Hyperopic Presbyopic Eyes

PURPOSE To evaluate the efficacy of simultaneous laser in situ keratomileusis (LASIK) and small-aperture corneal inlay (KAMRA; AcuFocus, Inc) implantation in hyperopic presbyopic eyes at 5 years postoperatively. METHODS This was a retrospective single-center study of patients with hyperopia and presbyopia who underwent simultaneous LASIK and corneal inlay implantation by two experienced refractive surgeons. These patients were regularly observed for 5 years and evaluated with serial corneal tomographies and refractive assessments for uncorrected near visual acuity (UNVA), uncorrected distance visual acuity (UDVA), corrected distance visual acuity (CDVA), distance-corrected near visual acuity (DCNVA), and manifest refraction spherical equivalent (MRSE). RESULTS Twenty-four eyes of 24 patients were included. Mean age was 53.63 ± 4.11 years (range: 47 to 63 years) and mean preoperative MRSE was +1.52 ± 0.64 diopters (D) (range: +0.50 to +3.00 D). UNVA was 0.04 ± 0.06 logMAR at 1 month and 0.02 ± 0.05 logMAR (J1+ equivalent) at 5 years postoperatively. In comparison, preoperative DCNVA was 0.44 ± 0.20 (J5/J6 equivalent) (P < .001). At 5 years postoperatively, UDVA was 0.16 ± 0.18 logMAR (20/30 Snellen equivalent), and 23 of 24 eyes (95.8%) had UNVA of J3 or better. Two eyes (8.3%) lost one line of CDVA. One corneal inlay needed readjustment but none were explanted. Eight eyes (25%) developed regression in UNVA with hyperopic shift, which responded to a 3- to 4-month course of topical steroids, with 3 eyes showing patchy haze on the undersurface of the corneal inlay. CONCLUSIONS Simultaneous LASIK and KAMRA inlay implantation, evaluated for 5 years postoperatively, shows some efficacy and predictability in improving UDVA and UNVA in hyperopic presbyopic eyes. However, late-onset regression with hyperopic shift, possible loss of CDVA, and occasional haze remain challenges. [J Refract Surg. 2020;36(8):498-505.].