Visual outcomes and safety of a refractive corneal inlay for presbyopia using femtosecond laser.

PURPOSE To evaluate the outcomes and safety of a refractive inlay (Flexivue Micro-Lens, Presbia Coöperatief U.A.) for the corneal compensation of presbyopia. METHODS This prospective, interventional clinical study comprised 47 emmetropic presbyopes with a mean age of 52±4 years (range: 45 to 60 years). The inlay was inserted, centered on the line of sight, inside a corneal pocket created in the patient's nondominant eye, using a femtosecond laser. Follow-up was 12 months. Visual acuity, corneal topography, wavefront aberrometry, contrast sensitivity, structural corneal alterations, and questionnaires were evaluated. RESULTS Twelve months after surgery, uncorrected near visual acuity was 20/32 or better in 75% of operated eyes, whereas mean uncorrected distance visual acuity (UDVA) of operated eyes was statistically significantly decreased from 0.06±0.09 logMAR (20/20) (range: -0.08 to 0.26) preoperatively to 0.38±0.15 logMAR (20/50) (range: 0.12 to 0.8) (P<.001), and mean binocular UDVA was not significantly altered (P=.516). Seventeen patients lost one line of corrected distance visual acuity in the operated eye. No patient lost 2 lines in CDVA in the operated eye. Overall, higher order aberrations increased and contrast sensitivity decreased in the operated eye. No tissue alterations were found using corneal confocal microscopy. No intra- or postoperative complications occurred. CONCLUSIONS Twelve months after implantation, the Flexivue Micro-Lens intracorneal refractive inlay seems to be an effective method for the corneal compensation of presbyopia in emmetropic presbyopes aged between 45 and 60 years old.