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comparison of FDA safety and efficacy data for KAMRA and Raindrop corneal inlays

International Journal of Ophthalmology(English edition) 2017年第9期10卷 1446-1451页

作者： Majid Moshirfar Jordan D Desautels Ryan T Wallace nicholas koen.phillip c.hoopes HDR Research center Hoopes VisionDraperUtah 84020United States john A.Moran Eye center Department of Ophthalmology and Visual SciencesUniversity of Utah School of MedicineSalt Lake CityUtah 84132United States Tufts University School of Medicine BostonMassachusetts 02111United States Brigham Young University ProvoUtah 84602United States Brown University Alpert School of Medicine ProvidenceRhode Island 02906United States

AIM：To provide a side-by-side analysis of the summary of safety and effectiveness data（SSED）submitted to the FDA for the KAMRA and Raindrop corneal inlays for the correction of ***：SSED reports submitted to the FDA for KAMRA and Raindrop were compared with respect to loss of corrected distance visual acuity（cDVA）,adverse event rates,induction of astigmatism,retention of contrast sensitivity,stability of manifest refractive spherical equivalent（MRSE）,and achieved monocular uncorrected near visual acuity（UNVA）at ***：Totally 442/508 of KAMRA patients and344/373 Raindrop patients remained enrolled in the clinical trials at *** proportion of KAMRA and Raindrop patients who lost≥2 lines of cDVA at 24mo was 3.4%and1%,*** adverse event rate was comparable between the *** significant inductions of astigmatism were *** technologies induced a transient myopic shift in MRSE followed by a hyperopic shift and subsequent *** 87%of KAMRA and 98%of Raindrop patients attained a monocular UNVA of J5（20/40）or better at 24mo,28%of KAMRA and 67%of Raindrop patients attained a monocular UNVA of J1（20/20）or better at ***：Both devices can be considered safe and effective,however,the results of corneal inlay implantation are mixed,and long-term patient satisfaction will likely depend on subjective expectations about the capabilities of the *** in surgical technique and postoperative care within and between the two clinical trials diminishes the comparative power of this article.

关键词： KAMRA Raindrop presbyopia comeal inlay

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