AIM:To evaluate the light adjustable lens(LAL)vs a standard monofocal lens in achieving target astigmatic refraction and improving postoperative uncorrected distance visual acuity(UDVA).METHODS:This randomized control...AIM:To evaluate the light adjustable lens(LAL)vs a standard monofocal lens in achieving target astigmatic refraction and improving postoperative uncorrected distance visual acuity(UDVA).METHODS:This randomized controlled clinical trial included 40 patients with pre-existing astigmatism and visually significant cataract.Twenty-eight patients received the LAL and 12 control patients received a monofocal intraocular lens(IOL)after cataract extraction at a single institution.The patients with the LAL underwent adjustment by ultraviolet(UV)light postoperatively plus subsequent lock-in procedures and all patients returned to clinic for follow up of study parameters at 6,9,and 12 mo.Manifest refraction,distance visual acuity,and adverse events were recorded at each visit.RESULTS:The mean cylinder before adjustment in eyes with the LAL was-0.89±0.58 D(-2.00 to 0.00 D)and-0.34±0.34 D(-1.25 to 0.00 D)after lock-in(P=1.68 x10-8).The mean cylinder in patients with the monofocal lens was-1.00±0.32 D(-1.50 to-0.50 D)at 17-21 d postoperatively,which was statistically different from the LAL cylinder postlock-in(P=1.43 x10-6).UDVA in the LAL group was 20/20 or better in 79%of patients post lock-in with good stability over 12 mo compared with 33%of the control patients with UDVA of 20/20 or better.CONCLUSION:These results demonstrate that the LAL is more effective in achieving target refractions and improving postoperative UDVA in patients with pre-existing corneal astigmatism than a standard monofocal lens.展开更多
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
基金Supported by Research to Prevent Blindness(New York,New York)the clinical trial was sponsored by Rx Sight Inc.(formerly Calhoun Vision)
文摘AIM:To evaluate the light adjustable lens(LAL)vs a standard monofocal lens in achieving target astigmatic refraction and improving postoperative uncorrected distance visual acuity(UDVA).METHODS:This randomized controlled clinical trial included 40 patients with pre-existing astigmatism and visually significant cataract.Twenty-eight patients received the LAL and 12 control patients received a monofocal intraocular lens(IOL)after cataract extraction at a single institution.The patients with the LAL underwent adjustment by ultraviolet(UV)light postoperatively plus subsequent lock-in procedures and all patients returned to clinic for follow up of study parameters at 6,9,and 12 mo.Manifest refraction,distance visual acuity,and adverse events were recorded at each visit.RESULTS:The mean cylinder before adjustment in eyes with the LAL was-0.89±0.58 D(-2.00 to 0.00 D)and-0.34±0.34 D(-1.25 to 0.00 D)after lock-in(P=1.68 x10-8).The mean cylinder in patients with the monofocal lens was-1.00±0.32 D(-1.50 to-0.50 D)at 17-21 d postoperatively,which was statistically different from the LAL cylinder postlock-in(P=1.43 x10-6).UDVA in the LAL group was 20/20 or better in 79%of patients post lock-in with good stability over 12 mo compared with 33%of the control patients with UDVA of 20/20 or better.CONCLUSION:These results demonstrate that the LAL is more effective in achieving target refractions and improving postoperative UDVA in patients with pre-existing corneal astigmatism than a standard monofocal lens.
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.
