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. 2017 Sep 18;10(9):1446-1451.
doi: 10.18240/ijo.2017.09.18. eCollection 2017.

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

Majid Moshirfar  1   2 , Jordan D Desautels  1   3 , Ryan T Wallace  4 , Nicholas Koen  5 , Phillip C Hoopes  1
Affiliations

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

Majid Moshirfar et al. Int J Ophthalmol. .

Abstract

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 presbyopia.

Methods: 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.

Results: 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.

Conclusion: 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.

Keywords: KAMRA; Raindrop; corneal inlay; presbyopia.

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Figures

Figure 1
Figure 1. Percent of eyes showing a loss of two or more lines of CDVA at the given postoperative time points
Of note, the sample size diminishes throughout the course of follow up visits for both devices.
Figure 2
Figure 2. Percent of eyes with a preoperative CDVA of 20/40 or better that became worse than 20/40 postoperatively.
Figure 3
Figure 3. Percent of eyes experiencing a change in mean MRSE less than or equal to 1.0 D between 3mo intervals up to 24mo
Raindrop did not include data in the ranges: 0-1mo and >24mo.
Figure 4
Figure 4. Change in MRSE between specified postoperative intervals.
Figure 5
Figure 5. Efficacy results for monocular UNVA at 24mo.
See this image and copyright information in PMC

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