Small‐aperture corneal inlay for the correction of presbyopia: 3‐year follow‐up

PURPOSE: To report the 3‐year postoperative safety and efficacy outcomes of the Acufocus corneal inlay. SETTING: University Eye Clinic, Paracelsus Medical University, Salzburg, Austria. DESIGN: Prospective nonrandomized noncomparative cohort study. METHODS: The corneal inlay was implanted in the nondominant eye of naturally emmetropic presbyopic patients. Refraction, uncorrected near (UNVA), intermediate (UIVA), and distance (UDVA) visual acuities; corrected distance visual acuity (CDVA); contrast sensitivity; visual fields; subjective patient satisfaction and symptoms; and operative and postoperative adverse events and complications were evaluated. RESULTS: The study enrolled 32 patients. The mean UNVA improved from Jaeger (J) 6 preoperatively to J1 at 3 years and the mean UIVA, from 20/40 to 20/25, respectively. At 3 years, 97% of eyes had a UNVA of J3 or better and 91% had a UIVA of 20/32 or better. The mean UDVA was 20/20, with all eyes achieving 20/32 or better. Nine eyes (28.3%) lost 1 line of CDVA, 1 eye (3.1%) lost more than 2 lines (3.8 lines), and 3 eyes (9.3%) gained 1 line. No inlay was explanted, and no inflammatory reactions were observed. At 3 years, 15.6% of patients reported severe night‐vision problems and 6.3% (versus 87.5% preoperatively) reported being dependent on reading glasses. CONCLUSIONS: These 3‐year results support the safety and efficacy of the corneal inlay to correct presbyopia in naturally emmetropic presbyopic patients. However, despite a significant gain in UNVA and UIVA, 28.3% of patients lost 1 line of CDVA. Financial Disclosure: Acufocus, Inc., California, USA, financially supports the Research Foundation for Promoting Opthhalmology, Salzburg, Austria, as the clinical research center of the University Eye Clinic, Paracelsus Medical University, Salzburg. Dr. Grabner received travel expenses from Acufocus, Inc. Dr. Riha currently works as a clinical application specialist for Acufocus, Inc. Drs. Seyeddain, Hohensinn, Nix, Rückl, and Dexl have no financial or proprietary interest in any material or method mentioned.