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A 3-year follow-up study of a new corneal inlay: clinical results and outcomes
  1. Sandra Maria Canelas Beer1,
  2. Liliana Werner2,
  3. Eliane Mayumi Nakano1,
  4. Rodrigo T Santos1,
  5. Flavio Hirai3,
  6. Enrico J Nitschke3,
  7. Claudia Francesconi Benicio1,
  8. Mauro S Q Campos1
  1. 1Department of Refractive Surgery, Universidade Federal de Sao Paulo, Sao Paulo, Brazil
  2. 2Department of Ophthalmology and Visual Sciencies, University of Utah, Salt Lake City, Utah, USA
  3. 3Department of Ophthalmology, Universidade Federal de Sao Paulo Escola Paulista de Medicina, Sao Paulo, Brazil
  1. Correspondence to Dr Sandra Maria Canelas Beer, Refractive Surgery, Universidade Federal de Sao Paulo, Sao Paulo 9581-460, 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.

  • Bifocal refractive corneal inlay
  • Intracorneal inlay
  • presbyopia
  • cornea
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Footnotes

  • Presented at Tis papaer was presented at the following meetings: AAO 2015, ESCRS 2016 and SIMASP 2017.

  • Funding LW: supported in part by an unrestricted grant from Research to Prevent Blindness, Inc, New York City, New York, USA to the Department of Ophthalmology and Visual Sciences, University of Utah.

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

  • Patient consent for publication Obtained.

  • Ethics approval The study had ethical approval from the Institutional Ethics Committee, Hospital São Paulo. This clinical trial was performed at the Department of Refractive Surgery, Federal University of São Paulo, UNIFESP, São Paulo, Brazil.

  • Provenance and peer review Not commissioned; externally peer reviewed.

  • Data availability statement Data are available on request.

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