One-Year Clinical Outcomes of a Corneal Inlay for Presbyopia.

PURPOSE: To report the results of a 1-year follow-up analysis of the safety and efficacy of the Flexivue Microlens corneal inlay.

METHODS

The Flexivue Microlens corneal inlay was implanted in the nondominant eye of patients with emmetropic presbyopia (a spherical equivalent of -0.5 to 1.00 diopter) after the creation of a 300-μm deep stromal pocket, using a femtosecond laser. The patients were followed up according to a clinical protocol involving refraction, anterior segment imaging analysis (Oculyzer), and optical quality analysis (OPD-Scan).

RESULTS

Thirty-one patients were enrolled in this ongoing study. The mean age was 50.7 years (range 45-60 yrs), and 70% of the patients were female. The mean uncorrected near visual acuity improved to Jaeger 1 in 87.1% of the eyes treated with the inlays. All eyes improved 4 lines at all visits. The binocular uncorrected distance visual acuity was 20/20 in all patients. Ninety percent of the patients reported that their near vision was good or excellent. Some of the patients (16.1%) lost more than 3 lines of corrected distance visual acuity. At the latest follow-up, induction of a corneal spherical aberration to improve near visual acuity was statistically significant. No other intraoperative or postoperative complication was noted.

CONCLUSIONS

The Flexivue Microlens provided patients with improved near vision, as a result of a negative spherical aberration. A significant loss of corrected distance visual acuity in the operated eyes was observed. Overall, this intracorneal inlay was an effective alternative to other procedures for the correction of presbyopia.