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.

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.