Format

Send to

Choose Destination
Br J Ophthalmol. 2019 Aug 24. pii: bjophthalmol-2019-314314. doi: 10.1136/bjophthalmol-2019-314314. [Epub ahead of print]

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

Author information

1
Department of Refractive Surgery, Universidade Federal de Sao Paulo, Sao Paulo, Brazil.
2
Department of Ophthalmology and Visual Sciencies, University of Utah, Salt Lake City, Utah, USA.
3
Department of Ophthalmology, Universidade Federal de Sao Paulo Escola Paulista de Medicina, Sao Paulo, Brazil.

Abstract

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.

KEYWORDS:

Bifocal refractive corneal inlay; Intracorneal inlay; cornea; presbyopia

Conflict of interest statement

Competing interests: The correspondent author is a consultant for Presbia.

Supplemental Content

Full text links

Icon for HighWire
Loading ...
Support Center