Visual Prognosis after Explantation of Small-Aperture Corneal Inlays in Presbyopic Eyes: A Case Series
Medical hypothesis discovery and innovation in ophthalmology,
Vol. 8 No. 3 (2019),
20 September 2019
AbstractThe 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.
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.
Dexl AK, Jell G, Strohmaier C, Seyeddain O, Riha W, Ruckl T, et al. Long-term outcomes after monocular corneal inlay implantation for the surgical compensation of presbyopia. J Cataract Refract Surg. 2015;41(3):566-75. doi: 10.1016/j.jcrs.2014.05.051 pmid: 25726504
Jalali S, Aus der Au W, Shaarawy T. AcuFocus Corneal Inlay to Correct Presbyopia Using Femto-LASIK. One Year Results of a Prospective Cohort Study. Klin Monbl Augenheilkd. 2016;233(4):360-4. doi: 10.1055/s-0041-111804 pmid: 27116483
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
Ong HS, Chan AS, Yau CW, Mehta JS. Corneal Inlays for Presbyopia Explanted Due to Corneal Haze. J Refract Surg. 2018;34(5):357-60. doi: 10.3928/1081597X-20180308-01 pmid: 29738595
SBWire. Corneal Implantable Devices Market - Global Industry Analysis, Size, Share, Growth, Trends and Forec. Available from: http://www.sbwire.com/press-releases/corneal-implantable-devices/release-996581.htm? utm_source=djournal&utm_medium=feed&utm_campaign=distribution.
Yilmaz OF, Alagoz N, Pekel G, Azman E, Aksoy EF, Cakir H, et al. Intracorneal inlay to correct presbyopia: Long-term results. J Cataract Refract Surg. 2011;37(7):1275-81. doi: 10.1016/j.jcrs.2011.01.027 pmid: 21570249
Igras E, O'Caoimh R, O'Brien P, Power W. Long-term Results of Combined LASIK and Monocular Small-Aperture Corneal Inlay Implantation. J Refract Surg. 2016;32(6):379-84. doi: 10.3928/1081597X-20160317-01 pmid: 27304601
Moshirfar M, Desautels JD, Wallace RT, Koen N, Hoopes PC. Comparison of FDA safety and efficacy data for KAMRA and Raindrop corneal inlays. Int J Ophthalmol. 2017;10(9):1446-51. doi: 10.18240/ijo.2017.09.18 pmid: 28944206
Alio JL, Abbouda A, Huseynli S, Knorz MC, Homs ME, Durrie DS. Removability of a small aperture intracorneal inlay for presbyopia correction. J Refract Surg. 2013;29(8):550-6. doi: 10.3928/1081597X-20130719-05 pmid: 23909782
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