Performance and Safety of the Extended Depth of Focus Implantable Collamer® Lens (EDOF ICL) in Phakic Subjects with Presbyopia

Performance and Safety of the Extended Depth of Focus Implantable Collamer® Lens (EDOF ICL) in Phakic Subjects with Presbyopia

Mark Packer,1 Jose F Alfonso,2 Jaime Aramberri,3 Daniel Elies,4 Joaquin Fernandez,5 Erik Mertens6 1Packer Research Associates, Boulder, CO, USA; 2Ophthalmology Institute Fernández Vega, Oviedo, Asturias, Spain; 3Opthalmology Clinic Miranza Begitek, San Sebastian, Spain; 4Institute of Ocul...

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Autores principales: Packer M, Alfonso JF, Aramberri J, Elies D, Fernandez J, Mertens E
Formato: article
Lenguaje:EN
Publicado: Dove Medical Press 2020
Materias:
presbyopia
myopia
phakic refractive lens
implantable collamer lens
Ophthalmology
RE1-994
Acceso en línea:https://doaj.org/article/6db2d3a00733405a801e58ecf6300b93
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spelling oai:doaj.org-article:6db2d3a00733405a801e58ecf6300b932021-12-02T10:20:48ZPerformance and Safety of the Extended Depth of Focus Implantable Collamer® Lens (EDOF ICL) in Phakic Subjects with Presbyopia1177-5483https://doaj.org/article/6db2d3a00733405a801e58ecf6300b932020-09-01T00:00:00Zhttps://www.dovepress.com/performance-and-safety-of-the-extended-depth-of-focus-implantable-coll-peer-reviewed-article-OPTHhttps://doaj.org/toc/1177-5483Mark Packer,1 Jose F Alfonso,2 Jaime Aramberri,3 Daniel Elies,4 Joaquin Fernandez,5 Erik Mertens6 1Packer Research Associates, Boulder, CO, USA; 2Ophthalmology Institute Fernández Vega, Oviedo, Asturias, Spain; 3Opthalmology Clinic Miranza Begitek, San Sebastian, Spain; 4Institute of Ocular Microsurgery, Barcelona, Spain; 5Qvision-Hospital Vithas Virgen del Mar, Almeria, Spain; 6Medipolis, Antwerp, BelgiumCorrespondence: Mark PackerPacker Research Associates, Boulder, CO, USATel +1 541 915 0291Email mark@markpackerconsulting.comPurpose: To evaluate the performance and safety of the Extended Depth of Focus Implantable Collamer® Lens (EDOF ICL) for improvement of uncorrected near, intermediate and distance visual acuity in phakic subjects with myopia and presbyopia.Design: Prospective multicenter study.Methods: Presbyopic subjects who required an EDOF ICL in the range of − 0.50 D to − 18.00 D, exhibited ≤ 0.75 D refractive astigmatism and required from +1.00 to +2.50 D reading add were implanted bilaterally. Assessments at 6 months included uncorrected near, intermediate and distance visual acuities, defocus curves, contrast sensitivity, responses to the National Eye Institute Refractive Error Quality of Life Questionnaire and a Task Assessment Questionnaire.Results: A total of 34 subjects completed the study. Investigators targeted emmetropia in all eyes. Mean binocular uncorrected near, intermediate and distance visual acuities measured logMAR − 0.01 ± 0.05 (20/20), − 0.02 ± 0.08 (20/19) and 0.07 ± 0.10 (20/23), respectively. Mean monocular uncorrected near, intermediate and distance visual acuities measured logMAR 0.068 ± 0.09 (20/23), 0.062 ± 0.10 (20/23) and 0.16 ± 0.12 (20/29). There were no clinically or statistically significant differences in contrast sensitivity between baseline and 6 months under any testing conditions. Subjects reported significant improvements in measures of vision-related quality of life and ability to perform tasks at all distances without glasses or contact lenses. Overall, satisfaction with the EDOF ICL was high: postoperatively, 91.2% of subjects were satisfied with their vision.Conclusion: This multicenter, prospective clinical investigation demonstrated the ability of the EDOF ICL to correct myopia and presbyopia, resulting in improvement of uncorrected near, intermediate and distance visual acuity without compromising the quality of vision. The EDOF ICL allowed subjects to perform tasks of daily living without glasses or contact lenses. Subjects reported significant improvements in quality of life with high levels of spectacle independence and satisfaction.Keywords: presbyopia, myopia, phakic refractive lens, implantable Collamer lensPacker MAlfonso JFAramberri JElies DFernandez JMertens EDove Medical Pressarticlepresbyopiamyopiaphakic refractive lensimplantable collamer lensOphthalmologyRE1-994ENClinical Ophthalmology, Vol Volume 14, Pp 2717-2730 (2020)
institution DOAJ
collection DOAJ
language EN
topic presbyopia
myopia
phakic refractive lens
implantable collamer lens
Ophthalmology
RE1-994
spellingShingle presbyopia
myopia
phakic refractive lens
implantable collamer lens
Ophthalmology
RE1-994
Packer M
Alfonso JF
Aramberri J
Elies D
Fernandez J
Mertens E
Performance and Safety of the Extended Depth of Focus Implantable Collamer® Lens (EDOF ICL) in Phakic Subjects with Presbyopia
description Mark Packer,1 Jose F Alfonso,2 Jaime Aramberri,3 Daniel Elies,4 Joaquin Fernandez,5 Erik Mertens6 1Packer Research Associates, Boulder, CO, USA; 2Ophthalmology Institute Fernández Vega, Oviedo, Asturias, Spain; 3Opthalmology Clinic Miranza Begitek, San Sebastian, Spain; 4Institute of Ocular Microsurgery, Barcelona, Spain; 5Qvision-Hospital Vithas Virgen del Mar, Almeria, Spain; 6Medipolis, Antwerp, BelgiumCorrespondence: Mark PackerPacker Research Associates, Boulder, CO, USATel +1 541 915 0291Email mark@markpackerconsulting.comPurpose: To evaluate the performance and safety of the Extended Depth of Focus Implantable Collamer® Lens (EDOF ICL) for improvement of uncorrected near, intermediate and distance visual acuity in phakic subjects with myopia and presbyopia.Design: Prospective multicenter study.Methods: Presbyopic subjects who required an EDOF ICL in the range of − 0.50 D to − 18.00 D, exhibited ≤ 0.75 D refractive astigmatism and required from +1.00 to +2.50 D reading add were implanted bilaterally. Assessments at 6 months included uncorrected near, intermediate and distance visual acuities, defocus curves, contrast sensitivity, responses to the National Eye Institute Refractive Error Quality of Life Questionnaire and a Task Assessment Questionnaire.Results: A total of 34 subjects completed the study. Investigators targeted emmetropia in all eyes. Mean binocular uncorrected near, intermediate and distance visual acuities measured logMAR − 0.01 ± 0.05 (20/20), − 0.02 ± 0.08 (20/19) and 0.07 ± 0.10 (20/23), respectively. Mean monocular uncorrected near, intermediate and distance visual acuities measured logMAR 0.068 ± 0.09 (20/23), 0.062 ± 0.10 (20/23) and 0.16 ± 0.12 (20/29). There were no clinically or statistically significant differences in contrast sensitivity between baseline and 6 months under any testing conditions. Subjects reported significant improvements in measures of vision-related quality of life and ability to perform tasks at all distances without glasses or contact lenses. Overall, satisfaction with the EDOF ICL was high: postoperatively, 91.2% of subjects were satisfied with their vision.Conclusion: This multicenter, prospective clinical investigation demonstrated the ability of the EDOF ICL to correct myopia and presbyopia, resulting in improvement of uncorrected near, intermediate and distance visual acuity without compromising the quality of vision. The EDOF ICL allowed subjects to perform tasks of daily living without glasses or contact lenses. Subjects reported significant improvements in quality of life with high levels of spectacle independence and satisfaction.Keywords: presbyopia, myopia, phakic refractive lens, implantable Collamer lens
format article
author Packer M
Alfonso JF
Aramberri J
Elies D
Fernandez J
Mertens E
author_facet Packer M
Alfonso JF
Aramberri J
Elies D
Fernandez J
Mertens E
author_sort Packer M
title Performance and Safety of the Extended Depth of Focus Implantable Collamer® Lens (EDOF ICL) in Phakic Subjects with Presbyopia
title_short Performance and Safety of the Extended Depth of Focus Implantable Collamer® Lens (EDOF ICL) in Phakic Subjects with Presbyopia
title_full Performance and Safety of the Extended Depth of Focus Implantable Collamer® Lens (EDOF ICL) in Phakic Subjects with Presbyopia
title_fullStr Performance and Safety of the Extended Depth of Focus Implantable Collamer® Lens (EDOF ICL) in Phakic Subjects with Presbyopia
title_full_unstemmed Performance and Safety of the Extended Depth of Focus Implantable Collamer® Lens (EDOF ICL) in Phakic Subjects with Presbyopia
title_sort performance and safety of the extended depth of focus implantable collamer® lens (edof icl) in phakic subjects with presbyopia
publisher Dove Medical Press
publishDate 2020
url https://doaj.org/article/6db2d3a00733405a801e58ecf6300b93
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AT aramberrij performanceandsafetyoftheextendeddepthoffocusimplantablecollamerreglensedoficlinphakicsubjectswithpresbyopia
AT eliesd performanceandsafetyoftheextendeddepthoffocusimplantablecollamerreglensedoficlinphakicsubjectswithpresbyopia
AT fernandezj performanceandsafetyoftheextendeddepthoffocusimplantablecollamerreglensedoficlinphakicsubjectswithpresbyopia
AT mertense performanceandsafetyoftheextendeddepthoffocusimplantablecollamerreglensedoficlinphakicsubjectswithpresbyopia
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