A 3-year follow-up study of a new corneal inlay: clinical results and outcomes.

PURPOSE: Here, we report the results of a 3-year follow-up analysis of the outcomes of the Flexivue Microlens corneal inlay.

PATIENTS: Non-dominant eyes (n=31) of emmetropic presbyopic patients (spherical equivalent: -0.5 to 1.00 dioptre).

METHODS

A Flexivue Microlens corneal inlay was implanted after the creation of a 300 μm deep stromal pocket using a femtosecond laser. Patients were followed up according to a clinical protocol involving refraction, anterior segment imaging analysis (Oculyser), optical quality analysis (OPD-Scan), monocular binocular uncorrected and corrected visual acuity tests, contrast sensitivity measurements (photopic and mesopic), satisfaction questionnaire results and adverse event reporting.

RESULTS

Thirty patients were examined at the 3-year follow-up in this ongoing study. The mean uncorrected near visual acuity improved to Jaeger 1 in 76.9% of eyes treated with the inlays (vs 87.1% at the 1-year follow-up). All eyes improved four lines in all visits, except for four patients for whom the inlay was explanted. Patients reported that their near vision was good or excellent in 73.3% of cases (vs 90.3% in the first year). The UDVA remained stable over time. Three patients were explanted due to blurred vision for near-point and far-point distances. One patient developed a superficial corneal ulcer after 20 months. Two patients underwent cataract removal. Four patients underwent inlay exchange to increase near power correction.

CONCLUSIONS

The Presbia Flexivue Microlens provided presbyopia treatment by improving near vision. Manageable complications may occur over the long term.

CLINICAL TRIAL REGISTRATION NUMBER: U1111-1185-5684 and 0310451200000550.