Six-month visual outcomes for the correction of presbyopia using a small-aperture corneal inlay: single-site experience

OBJECTIVE The objective of this study was to describe 6-month postoperative efficacy and safety outcomes after monocular KAMRA corneal inlay implantation in emmetropic presbyopic patients. STUDY DESIGN This study followed a retrospective chart analysis. SETTING This study was performed at Hoopes Vision in Draper, UT, USA. SUBJECTS AND METHODS Fifty-seven patients met the inclusion criteria of this study and underwent KAMRA corneal inlay implantation following the approval of the United States Food and Drug Association between May 2015 and April 2016 at a single site. Surgery involved femtosecond laser-created corneal pockets of various depths. Efficacy, safety, and patient satisfaction reports were analyzed at 3 and 6 months. RESULTS At 6 months follow-up, the monocular uncorrected near visual acuity (UNVA) was Jaeger (J) 4 (20/32), the mean uncorrected distance visual acuity was 20/25, and the mean corrected distance visual acuity was 20/20. At 6 months, 71% of patients with a pocket depth of ≥250 μm had a UNVA of 20/20 or better, whereas only 22% of patients with a shallow pocket depth of <250 μm had a UNVA of 20/20 or better. There was no statistical difference in UNVA at 6 months between virgin eyes and post-LASIK eyes. One patient had an explant and five patients underwent inlay recentration, all of which resulted in improved visual acuity. At 6 months, 72% of patients reported some level of satisfaction, 26% of patients reported being "not dependent" on reading glasses, and 62% of patients reported being able to do most things in bright light without reading glasses. CONCLUSION For patients with emmetropic presbyopia, the KAMRA inlay is a viable treatment option resulting in improved UNVA. Increased pocket depth may be associated with better postoperative outcomes. Safety rates are high, while explantation and recentering rates are low. Overall, patient satisfaction of the KAMRA inlay is good.