Majid Moshirfar1,2, Jordan D Desautels1,3, Ryan T Wallace4, Nicholas Koen5, Phillip C Hoopes1. 1. HDR Research Center, Hoopes Vision, Draper, Utah 84020, United States. 2. John A. Moran Eye Center, Department of Ophthalmology and Visual Sciences, University of Utah School of Medicine, Salt Lake City, Utah 84132, United States. 3. Tufts University School of Medicine, Boston, Massachusetts 02111, United States. 4. Brigham Young University, Provo, Utah 84602, United States. 5. Brown University Alpert School of Medicine, Providence, Rhode Island 02906, United States.
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.
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.
Authors: Brien A Holden; Timothy R Fricke; S May Ho; Reg Wong; Gerhard Schlenther; Sonja Cronjé; Anthea Burnett; Eric Papas; Kovin S Naidoo; Kevin D Frick Journal: Arch Ophthalmol Date: 2008-12
Authors: 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 Jr Hoopes Journal: Med Hypothesis Discov Innov Ophthalmol Date: 2019
Authors: Majid Moshirfar; Benjamin Buckner; David B Rosen; Madeline B Heiland; Yasmyne C Ronquillo; David F Skanchy; Harry Y Liu; Tim Melton; Liliana Werner; Phillip C Jr Hoopes Journal: Med Hypothesis Discov Innov Ophthalmol Date: 2019
Authors: Majid Moshirfar; Marshall K Henrie; Carter J Payne; Briana K Ply; Yasmyne C Ronquillo; Steven H Linn; Phillip C Hoopes Journal: Clin Ophthalmol Date: 2022-08-24
Authors: Michael S Korenfeld; Stella M Robertson; Jerry M Stein; David G Evans; Steven H Rauchman; Kenneth N Sall; Subha Venkataraman; Bee-Lian Chen; Mark Wuttke; William Burns Journal: Eye (Lond) Date: 2021-01-29 Impact factor: 3.775