Refractive surgical correction of presbyopia with the AcuFocus small aperture corneal inlay: two-year follow-up.

PURPOSE: To evaluate the safety and efficacy of the AcuFocus Corneal Inlay 7000 (ACI 7000) implanted in emmetropic presbyopic patients for the improvement of near and intermediate vision over 2-year follow-up.

METHODS: This prospective, non-randomized, non-comparative study included 32 naturally emmetropic presbyopic patients. The intracorneal inlay was implanted in the non-dominant eye over the pupil by creating a superior-hinged flap with the IntraLase 60-kHz femtosecond laser (Abbott Medical Optics). Inlay centration was over the line of sight. Minimum postoperative follow-up was 24 months.

RESULTS: After mean follow-up of 24.2±0.8 months (range: 24 to 26 months), 96.9% of patients read J3 or better in the implanted eye. Mean binocular uncorrected near visual acuity improved from J6 preoperatively to J1 after 24 months. Mean binocular uncorrected intermediate visual acuity (UIVA) was 20/20 at 1 month and remained 20/20 throughout 24-month follow-up, with 71.9% of eyes reaching UIVA of 20/20 or better. At 24 months, mean uncorrected distance visual acuity was 20/20 in the implanted eye and 20/16 binocularly. No inlay was explanted during the study. Two decentered inlays were recentered after 6 months because of in-sufficient increase in near and intermediate visual acuity. Both patients' near and intermediate visual acuity improved significantly after recentration.

CONCLUSIONS: The ACI 7000 seems to provide a safe and effective treatment for presbyopia over follow-up of 2 years.