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.