Moshirfar Majid, Desautels Jordan D, Wallace Ryan T, Koen Nicholas, Hoopes Phillip C
HDR Research Center, Hoopes Vision, Draper, Utah 84020, United States.
John A. Moran Eye Center, Department of Ophthalmology and Visual Sciences, University of Utah School of Medicine, Salt Lake City, Utah 84132, United States.
Int J Ophthalmol. 2017 Sep 18;10(9):1446-1451. doi: 10.18240/ijo.2017.09.18. eCollection 2017.
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 presbyopia.
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 24mo.
Totally 442/508 of KAMRA patients and 344/373 Raindrop patients remained enrolled in the clinical trials at 24mo. The proportion of KAMRA and Raindrop patients who lost ≥2 lines of CDVA at 24mo was 3.4% and 1%, respectively. The adverse event rate was comparable between the devices. No significant inductions of astigmatism were noted. Both technologies induced a transient myopic shift in MRSE followed by a hyperopic shift and subsequent stabilization. Totally 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 24mo.
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 inlays. Variability in surgical technique and postoperative care within and between the two clinical trials diminishes the comparative power of this article.
对提交给美国食品药品监督管理局（FDA）的用于矫正老花眼的KAMRA和Raindrop角膜嵌体的安全性和有效性数据摘要（SSED）进行对比分析。
比较提交给FDA的KAMRA和Raindrop的SSED报告，内容涉及矫正远视力（CDVA）丧失情况、不良事件发生率、散光诱导情况、对比敏感度保留情况、明显屈光球镜等效值（MRSE）的稳定性以及24个月时获得的单眼未矫正近视力（UNVA）。
在24个月时，KAMRA患者中有442/508例、Raindrop患者中有344/373例仍参与临床试验。在24个月时CDVA下降≥2行的KAMRA和Raindrop患者比例分别为3.4%和1%。两种器械的不良事件发生率相当。未观察到明显的散光诱导。两种技术均在MRSE上引起短暂的近视偏移，随后是远视偏移及随后的稳定。在24个月时，KAMRA患者中有87%、Raindrop患者中有98%单眼UNVA达到J5（20/40）或更好，KAMRA患者中有28%、Raindrop患者中有67%单眼UNVA达到J1（20/20）或更好。
两种器械均可认为是安全有效的，然而，角膜嵌体植入的结果不一，长期患者满意度可能取决于对嵌体功能的主观期望。两项临床试验内部及之间手术技术和术后护理的差异降低了本文的比较效力。
