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Medical hypothesis discovery and innovation in ophthalmology

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Visual Prognosis after Explantation of Small-Aperture Corneal Inlays in Presbyopic Eyes: A Case Series

  • Majid Moshirfar
  • David F. Skanchy
  • David B. Rosen
  • Madeline B. Heiland
  • Harry Y. Liu
  • Benjamin Buckner
  • Aaron T. Gomez
  • Yasmyne C. Ronquillo
  • Tim Melton
  • Phillip C. Hoopes Jr

Medical hypothesis discovery and innovation in ophthalmology, Vol. 8 No. 3 (2019), 20 September 2019 , Page 129-133
Published 1 October 2019

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Abstract

The purpose of this study was to report visual prognosis after explantation of a small-aperture corneal inlay used for the treatment of presbyopia. This is a retrospective case series conducted at a single site in Draper, Utah, USA (Hoopes Vision). Medical records of 176 patients who had received a small-aperture corneal inlay (KAMRAâ„¢, AcuFocus Inc., Irvine, CA, USA) were reviewed. Patients who had undergone explantation of the device were identified. Uncorrected distance visual acuity (UDVA), uncorrected near visual acuity (UNVA), corrected distance visual acuity (CDVA), and manifest refraction spherical equivalent (MRSE) were measured pre-implantation, post-implantation, pre-explantation, and post-explantation of the inlay. Ten eyes from ten patients were included in this study. The explantation rate was 5.7% over 31 months, with blurry vision as the most common complaint. After explantation, six patients achieved pre-implantation UDVA, and six achieved pre-implantation UNVA. Eight of nine patients who underwent final manifest refraction achieved pre-operative CDVA. All patients had residual donut-shaped corneal haze in the stroma at the previous position of the inlay. All patients experienced improvement in haze with 20% experiencing complete resolution. The degree of stromal haze was not related to the duration of implantation. Of the subset of patients who underwent explantation of their small-aperture corneal inlay, there was persistent loss of CDVA in 10%. The majority of patients experienced some level of residual stromal haze, which may contribute to deficits in UNVA and CDVA in few patients. A hyperopic shift induced by the corneal inlay may contribute to the blurry vision these patients experienced; there was a reduction of this shift post-explantation. While this device is removable, patients should expect some post-explantation changes such as residual haze with a small subset experiencing persistent deficits in CDVA.
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References

PMA P120023: FDA Summary of Safety and Effectiveness Data (SSED) 2019 [cited 2019 May 16]. Available from: https://www.accessdata.fda.gov/cdrh_docs/pdf12/ P120023B.pdf.

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Moshirfar M, Quist TS, Skanchy DF, Wallace RT, Linn SH, Hoopes PC, Jr. Six-month visual outcomes for the correction of presbyopia using a small-aperture corneal inlay: single-site experience. Clin Ophthalmol. 2016;10:2191-8. doi: 10.2147/OPTH.S115798 pmid: 27843289

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ISSN: 2322-3219

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