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

Abstract

PurposeHere, we report the results of a 3-year follow-up analysis of the outcomes of the Flexivue Microlens corneal inlay.PatientsNon-dominant eyes (n=31) of emmetropic presbyopic patients (spherical equivalent: −0.5 to 1.00 dioptre).MethodsA 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.ResultsThirty 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.ConclusionsThe Presbia Flexivue Microlens provided presbyopia treatment by improving near vision. Manageable complications may occur over the long term.Clinical trial registration numberU1111-1185-5684 and 0310451200000550.

A new trifocal corneal inlay for presbyopia

“…However, for RCIs there are no quantitative results to justify this hypothesis. Currently only two studies [4,11] describe only qualitatively what could happen with a Flexivue decentering. In this work the offset of the inlays was numerically evaluated and it is proven that it is critical for RCI in small pupils (See Fig.…”

“…Based on different physical principles, several types of CIs have been proposed, each one having its own strengths and weaknesses [2,3]. At present, the most successful, and widely studied, commercial CIs are the refractive Flexivue Microlens® (Presbia Cooperatief, UA, Irvine, CA, USA) [4][5][6][7], and the small aperture KAMRA® inlay (Acufocus, Inc., Irvine, CA, USA) [8][9][10].…”

“…Refractive Inlays (RI) act locally at central part of the cornea either, by modifying its curvature or by altering the refractive index to improve near vision. However, RIs produce a loss of uncorrected distance visual acuity (UDVA) and contrast sensitivity [4,5,7]. Besides, an increase of higher order aberrations in the operated eye, especially spherical aberration has also been reported [6,11].…”

Review of Presbyopia Treatment with Corneal Inlays and New Developments

“…This inlay contains a bifocal design with a central plano zone with no refractive power for distance and a peripheral positive refractive zone for near vision. 7 , 17 This refractive corneal inlay alters the corneal index of refraction to improve near vision performance. 4 Centration of the lens is guided by the line of sight (Purkinje Line).…”

“…A pocket at a depth of 300μm is created with a femtosecond laser, and the lens is inserted with the manufacturer’s tool. 17 A summary of the device properties and mechanism of action are in Table 1 . The lens remains available in approximately 50 countries worldwide.…”