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 subm...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 and344/373 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%and1%,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.展开更多
Purpose:The aim of this systematic review was to synthesize and appraise the evidence of the benefits of presbyopic correction on the cornea for visual function.Summary:Comprehensive search was conducted in MEDLINE us...Purpose:The aim of this systematic review was to synthesize and appraise the evidence of the benefits of presbyopic correction on the cornea for visual function.Summary:Comprehensive search was conducted in MEDLINE using keywords like“presbylasik”,“presbyopic refractive surgery”,“corneal pseudoaccommodation”and“corneal multifocality”.We reviewed corrected and uncorrected visual acuities for distance and near(uncorrected distance visual acuity(UDVA),uncorrected near visual acuity(UNVA),corrected distance visual acuity(CDVA),distance corrected near visual acuity(DCNVA),corrected near visual acuity(CNVA)),along with the refractive outcomes in spherical equivalent(SE)and astigmatism comparing the differences observed between preoperative myopic and hyperopic patients,as well as among techniques.Thirty-one studies met the inclusion and quality criteria.Monovision provides excellent distance and near uncorrected acuities,but with a 17%retreatment and a 5%reversal rate.Initial multifocal ablations result in 12%loss of 2 or more lines of CDVA,and a 21%retreatment rate.Laser Blended Vision provides excellent UDVA,but with a 19%retreatment rate.Initial experiences with Supracor show moderate predictability and a 22%retreatment rate.Intracor results in 9%loss of 2 or more lines of CDVA.KAMRA provides excellent UDVA,with only a 1%retreatment rate,but a 6%reversal rate.Initial experiences with PresbyMAX provided excellent UNVA and DCNVA,showing excellent predictability and a 1%reversal rate.Conclusions:The findings have implications for clinicians and policymakers in the health-care industry and emphasize the need for additional trials examining this important and widely performed clinical procedure.展开更多
文摘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 and344/373 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%and1%,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.
文摘Purpose:The aim of this systematic review was to synthesize and appraise the evidence of the benefits of presbyopic correction on the cornea for visual function.Summary:Comprehensive search was conducted in MEDLINE using keywords like“presbylasik”,“presbyopic refractive surgery”,“corneal pseudoaccommodation”and“corneal multifocality”.We reviewed corrected and uncorrected visual acuities for distance and near(uncorrected distance visual acuity(UDVA),uncorrected near visual acuity(UNVA),corrected distance visual acuity(CDVA),distance corrected near visual acuity(DCNVA),corrected near visual acuity(CNVA)),along with the refractive outcomes in spherical equivalent(SE)and astigmatism comparing the differences observed between preoperative myopic and hyperopic patients,as well as among techniques.Thirty-one studies met the inclusion and quality criteria.Monovision provides excellent distance and near uncorrected acuities,but with a 17%retreatment and a 5%reversal rate.Initial multifocal ablations result in 12%loss of 2 or more lines of CDVA,and a 21%retreatment rate.Laser Blended Vision provides excellent UDVA,but with a 19%retreatment rate.Initial experiences with Supracor show moderate predictability and a 22%retreatment rate.Intracor results in 9%loss of 2 or more lines of CDVA.KAMRA provides excellent UDVA,with only a 1%retreatment rate,but a 6%reversal rate.Initial experiences with PresbyMAX provided excellent UNVA and DCNVA,showing excellent predictability and a 1%reversal rate.Conclusions:The findings have implications for clinicians and policymakers in the health-care industry and emphasize the need for additional trials examining this important and widely performed clinical procedure.
