Quality of vision clinical outcomes for a new fully-refractive extended depth of focus Intraocular Lens
Background/objective To evaluate the visual performance of a purely refractive extended depth of focus (EDF) intraocular lens (IOL). Subjects/methods A prospective, multi-center, randomized, subject/evaluator-masked study. Subjects were bilaterally implanted with the EDF test (Model ZEN00V, TECNIS P...
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creator | Corbett, Dean Black, Daniel Roberts, Timothy V. Cronin, Brendan Gunn, David Bala, Chandra Versace, Patrick Tsai, Linda Papadatou, Eleni Alarcon, Aixa Vilupuru, Srividhya |
description | Background/objective
To evaluate the visual performance of a purely refractive extended depth of focus (EDF) intraocular lens (IOL).
Subjects/methods
A prospective, multi-center, randomized, subject/evaluator-masked study. Subjects were bilaterally implanted with the EDF test (Model ZEN00V, TECNIS PureSee™ IOL,
N
= 60) or an enhanced monofocal control (Model ICB00, TECNIS Eyhance™ IOL,
N
= 57) IOL. Monocular corrected distance (CDVA), intermediate (DCIVA), near acuities (DCNVA) and patient reported visual symptoms were evaluated at the 6-month visit. Monocular mesopic contrast sensitivity (CS) and depth of focus (DOF) testing were assessed at 3 months.
Results
CDVA (Mean ± SD) was −0.06 ± 0.08 for test and −0.05 ± 0.08 logMAR for control groups. DCIVA was 0.13 ± 0.08 for test and 0.18 ± 0.14 logMAR for control groups (
p
= 0.0127). DCNVA was 0.37 ± 0.10 for test and 0.43 ± 0.16 logMAR for control groups (
p
= 0.0137). Test lens was statistically superior for intermediate and near. Overall, 91.7% (halos), 95.0% (starbursts) and 95.0% (glare) of test lens patients reported that they did not experience, were not bothered, or were slightly bothered by specific visual symptoms, compared to 98.2%, 100% and 96.5% in the control group. The DOF range over which monocular visual acuity was 0.20 logMAR or better was −1.6 D for the test lens. Mesopic CS was comparable between both groups, falling within 0.11 log units for all measured cycles per degree with and without glare.
Conclusion
The EDF IOL demonstrated extended range of vision and statistically superior intermediate and near performance compared to the monofocal IOL. Distance visual acuity, contrast sensitivity and dysphotopsia profile were similar to the monofocal IOL. |
doi_str_mv | 10.1038/s41433-024-03039-8 |
format | Article |
fullrecord | <record><control><sourceid>proquest_pubme</sourceid><recordid>TN_cdi_pubmedcentral_primary_oai_pubmedcentral_nih_gov_11080637</recordid><sourceformat>XML</sourceformat><sourcesystem>PC</sourcesystem><sourcerecordid>3034244157</sourcerecordid><originalsourceid>FETCH-LOGICAL-c475t-d35cba884b518313d791eb4012ef364625778ee5e3aef4979c8e874e803e6d483</originalsourceid><addsrcrecordid>eNp9kV1rHCEYhSW0JNu0fyAXQehNb2x11NG5CiH0I7BQCg3kTlznnY3B1a3ObLr_vk43TT8ueqVwHo_veQ9CZ4y-ZZTrd0UwwTmhjSCUU94RfYQWTKiWSCHFM7SgnaSkaZrbE_SilHtKq6joMTrhWmqqBFug9ZfJBj_ucRrwzhefInbBR-9swGkaXdpAwUPK2OIID3iYQtiTDEO2bvQ7wPB9hNhDj3vYjnezy5DcVPB1HLOtt2AzXkIsL9HzwYYCrx7PU3Tz4f3Xq09k-fnj9dXlkjih5Eh6Lt3Kai1WkmnOeK86BitBWQMDb0XbSKU0gARuYRCd6pwGrQRoyqHthean6OLgu51WG-gdzHMEs81-Y_PeJOvN30r0d2addoYxqmnLVXV48-iQ07cJymg2vjgIwUZIUzF106IRgskZff0Pep-mHGu-SkmmZKfZTDUHyuVUSt3d0zSMmrlIcyjS1CLNzyLNnOP8zxxPT341VwF-AEqV4hry77__Y_sDbqWqLg</addsrcrecordid><sourcetype>Open Access Repository</sourcetype><iscdi>true</iscdi><recordtype>article</recordtype><pqid>3051759817</pqid></control><display><type>article</type><title>Quality of vision clinical outcomes for a new fully-refractive extended depth of focus Intraocular Lens</title><source>MEDLINE</source><source>Alma/SFX Local Collection</source><creator>Corbett, Dean ; Black, Daniel ; Roberts, Timothy V. ; Cronin, Brendan ; Gunn, David ; Bala, Chandra ; Versace, Patrick ; Tsai, Linda ; Papadatou, Eleni ; Alarcon, Aixa ; Vilupuru, Srividhya</creator><creatorcontrib>Corbett, Dean ; Black, Daniel ; Roberts, Timothy V. ; Cronin, Brendan ; Gunn, David ; Bala, Chandra ; Versace, Patrick ; Tsai, Linda ; Papadatou, Eleni ; Alarcon, Aixa ; Vilupuru, Srividhya</creatorcontrib><description>Background/objective
To evaluate the visual performance of a purely refractive extended depth of focus (EDF) intraocular lens (IOL).
Subjects/methods
A prospective, multi-center, randomized, subject/evaluator-masked study. Subjects were bilaterally implanted with the EDF test (Model ZEN00V, TECNIS PureSee™ IOL,
N
= 60) or an enhanced monofocal control (Model ICB00, TECNIS Eyhance™ IOL,
N
= 57) IOL. Monocular corrected distance (CDVA), intermediate (DCIVA), near acuities (DCNVA) and patient reported visual symptoms were evaluated at the 6-month visit. Monocular mesopic contrast sensitivity (CS) and depth of focus (DOF) testing were assessed at 3 months.
Results
CDVA (Mean ± SD) was −0.06 ± 0.08 for test and −0.05 ± 0.08 logMAR for control groups. DCIVA was 0.13 ± 0.08 for test and 0.18 ± 0.14 logMAR for control groups (
p
= 0.0127). DCNVA was 0.37 ± 0.10 for test and 0.43 ± 0.16 logMAR for control groups (
p
= 0.0137). Test lens was statistically superior for intermediate and near. Overall, 91.7% (halos), 95.0% (starbursts) and 95.0% (glare) of test lens patients reported that they did not experience, were not bothered, or were slightly bothered by specific visual symptoms, compared to 98.2%, 100% and 96.5% in the control group. The DOF range over which monocular visual acuity was 0.20 logMAR or better was −1.6 D for the test lens. Mesopic CS was comparable between both groups, falling within 0.11 log units for all measured cycles per degree with and without glare.
Conclusion
The EDF IOL demonstrated extended range of vision and statistically superior intermediate and near performance compared to the monofocal IOL. Distance visual acuity, contrast sensitivity and dysphotopsia profile were similar to the monofocal IOL.</description><identifier>ISSN: 0950-222X</identifier><identifier>ISSN: 1476-5454</identifier><identifier>EISSN: 1476-5454</identifier><identifier>DOI: 10.1038/s41433-024-03039-8</identifier><identifier>PMID: 38580741</identifier><language>eng</language><publisher>London: Nature Publishing Group UK</publisher><subject>692/308/409 ; 692/699/3161/3168 ; Acuity ; Aged ; Contrast Sensitivity - physiology ; Depth Perception - physiology ; Double-Blind Method ; Female ; Humans ; Intraocular lenses ; Laboratory Medicine ; Lens Implantation, Intraocular ; Lenses, Intraocular ; Male ; Medicine ; Medicine & Public Health ; Middle Aged ; Ophthalmology ; Patient Satisfaction ; Phacoemulsification ; Pharmaceutical Sciences/Technology ; Prospective Studies ; Prosthesis Design ; Pseudophakia - physiopathology ; Refraction, Ocular - physiology ; Surgery ; Surgical Oncology ; Vision ; Visual acuity ; Visual Acuity - physiology</subject><ispartof>Eye (London), 2024-05, Vol.38 (Suppl 1), p.9-14</ispartof><rights>The Author(s) 2024. corrected publication 2024</rights><rights>2024. The Author(s).</rights><rights>The Author(s) 2024. corrected publication 2024. This work is published under http://creativecommons.org/licenses/by/4.0/ (the “License”). Notwithstanding the ProQuest Terms and Conditions, you may use this content in accordance with the terms of the License.</rights><rights>The Author(s) 2024</rights><lds50>peer_reviewed</lds50><oa>free_for_read</oa><woscitedreferencessubscribed>false</woscitedreferencessubscribed><citedby>FETCH-LOGICAL-c475t-d35cba884b518313d791eb4012ef364625778ee5e3aef4979c8e874e803e6d483</citedby><cites>FETCH-LOGICAL-c475t-d35cba884b518313d791eb4012ef364625778ee5e3aef4979c8e874e803e6d483</cites><orcidid>0000-0001-8056-927X ; 0000-0002-4443-8915 ; 0000-0002-6288-0141 ; 0009-0006-2011-0807</orcidid></display><links><openurl>$$Topenurl_article</openurl><openurlfulltext>$$Topenurlfull_article</openurlfulltext><thumbnail>$$Tsyndetics_thumb_exl</thumbnail><link.rule.ids>230,314,780,784,885,27924,27925</link.rule.ids><backlink>$$Uhttps://www.ncbi.nlm.nih.gov/pubmed/38580741$$D View this record in MEDLINE/PubMed$$Hfree_for_read</backlink></links><search><creatorcontrib>Corbett, Dean</creatorcontrib><creatorcontrib>Black, Daniel</creatorcontrib><creatorcontrib>Roberts, Timothy V.</creatorcontrib><creatorcontrib>Cronin, Brendan</creatorcontrib><creatorcontrib>Gunn, David</creatorcontrib><creatorcontrib>Bala, Chandra</creatorcontrib><creatorcontrib>Versace, Patrick</creatorcontrib><creatorcontrib>Tsai, Linda</creatorcontrib><creatorcontrib>Papadatou, Eleni</creatorcontrib><creatorcontrib>Alarcon, Aixa</creatorcontrib><creatorcontrib>Vilupuru, Srividhya</creatorcontrib><title>Quality of vision clinical outcomes for a new fully-refractive extended depth of focus Intraocular Lens</title><title>Eye (London)</title><addtitle>Eye</addtitle><addtitle>Eye (Lond)</addtitle><description>Background/objective
To evaluate the visual performance of a purely refractive extended depth of focus (EDF) intraocular lens (IOL).
Subjects/methods
A prospective, multi-center, randomized, subject/evaluator-masked study. Subjects were bilaterally implanted with the EDF test (Model ZEN00V, TECNIS PureSee™ IOL,
N
= 60) or an enhanced monofocal control (Model ICB00, TECNIS Eyhance™ IOL,
N
= 57) IOL. Monocular corrected distance (CDVA), intermediate (DCIVA), near acuities (DCNVA) and patient reported visual symptoms were evaluated at the 6-month visit. Monocular mesopic contrast sensitivity (CS) and depth of focus (DOF) testing were assessed at 3 months.
Results
CDVA (Mean ± SD) was −0.06 ± 0.08 for test and −0.05 ± 0.08 logMAR for control groups. DCIVA was 0.13 ± 0.08 for test and 0.18 ± 0.14 logMAR for control groups (
p
= 0.0127). DCNVA was 0.37 ± 0.10 for test and 0.43 ± 0.16 logMAR for control groups (
p
= 0.0137). Test lens was statistically superior for intermediate and near. Overall, 91.7% (halos), 95.0% (starbursts) and 95.0% (glare) of test lens patients reported that they did not experience, were not bothered, or were slightly bothered by specific visual symptoms, compared to 98.2%, 100% and 96.5% in the control group. The DOF range over which monocular visual acuity was 0.20 logMAR or better was −1.6 D for the test lens. Mesopic CS was comparable between both groups, falling within 0.11 log units for all measured cycles per degree with and without glare.
Conclusion
The EDF IOL demonstrated extended range of vision and statistically superior intermediate and near performance compared to the monofocal IOL. Distance visual acuity, contrast sensitivity and dysphotopsia profile were similar to the monofocal IOL.</description><subject>692/308/409</subject><subject>692/699/3161/3168</subject><subject>Acuity</subject><subject>Aged</subject><subject>Contrast Sensitivity - physiology</subject><subject>Depth Perception - physiology</subject><subject>Double-Blind Method</subject><subject>Female</subject><subject>Humans</subject><subject>Intraocular lenses</subject><subject>Laboratory Medicine</subject><subject>Lens Implantation, Intraocular</subject><subject>Lenses, Intraocular</subject><subject>Male</subject><subject>Medicine</subject><subject>Medicine & Public Health</subject><subject>Middle Aged</subject><subject>Ophthalmology</subject><subject>Patient Satisfaction</subject><subject>Phacoemulsification</subject><subject>Pharmaceutical Sciences/Technology</subject><subject>Prospective Studies</subject><subject>Prosthesis Design</subject><subject>Pseudophakia - physiopathology</subject><subject>Refraction, Ocular - physiology</subject><subject>Surgery</subject><subject>Surgical Oncology</subject><subject>Vision</subject><subject>Visual acuity</subject><subject>Visual Acuity - physiology</subject><issn>0950-222X</issn><issn>1476-5454</issn><issn>1476-5454</issn><fulltext>true</fulltext><rsrctype>article</rsrctype><creationdate>2024</creationdate><recordtype>article</recordtype><sourceid>C6C</sourceid><sourceid>EIF</sourceid><recordid>eNp9kV1rHCEYhSW0JNu0fyAXQehNb2x11NG5CiH0I7BQCg3kTlznnY3B1a3ObLr_vk43TT8ueqVwHo_veQ9CZ4y-ZZTrd0UwwTmhjSCUU94RfYQWTKiWSCHFM7SgnaSkaZrbE_SilHtKq6joMTrhWmqqBFug9ZfJBj_ucRrwzhefInbBR-9swGkaXdpAwUPK2OIID3iYQtiTDEO2bvQ7wPB9hNhDj3vYjnezy5DcVPB1HLOtt2AzXkIsL9HzwYYCrx7PU3Tz4f3Xq09k-fnj9dXlkjih5Eh6Lt3Kai1WkmnOeK86BitBWQMDb0XbSKU0gARuYRCd6pwGrQRoyqHthean6OLgu51WG-gdzHMEs81-Y_PeJOvN30r0d2addoYxqmnLVXV48-iQ07cJymg2vjgIwUZIUzF106IRgskZff0Pep-mHGu-SkmmZKfZTDUHyuVUSt3d0zSMmrlIcyjS1CLNzyLNnOP8zxxPT341VwF-AEqV4hry77__Y_sDbqWqLg</recordid><startdate>20240501</startdate><enddate>20240501</enddate><creator>Corbett, Dean</creator><creator>Black, Daniel</creator><creator>Roberts, Timothy V.</creator><creator>Cronin, Brendan</creator><creator>Gunn, David</creator><creator>Bala, Chandra</creator><creator>Versace, Patrick</creator><creator>Tsai, Linda</creator><creator>Papadatou, Eleni</creator><creator>Alarcon, Aixa</creator><creator>Vilupuru, Srividhya</creator><general>Nature Publishing Group UK</general><general>Nature Publishing Group</general><scope>C6C</scope><scope>CGR</scope><scope>CUY</scope><scope>CVF</scope><scope>ECM</scope><scope>EIF</scope><scope>NPM</scope><scope>AAYXX</scope><scope>CITATION</scope><scope>7TK</scope><scope>K9.</scope><scope>7X8</scope><scope>5PM</scope><orcidid>https://orcid.org/0000-0001-8056-927X</orcidid><orcidid>https://orcid.org/0000-0002-4443-8915</orcidid><orcidid>https://orcid.org/0000-0002-6288-0141</orcidid><orcidid>https://orcid.org/0009-0006-2011-0807</orcidid></search><sort><creationdate>20240501</creationdate><title>Quality of vision clinical outcomes for a new fully-refractive extended depth of focus Intraocular Lens</title><author>Corbett, Dean ; Black, Daniel ; Roberts, Timothy V. ; Cronin, Brendan ; Gunn, David ; Bala, Chandra ; Versace, Patrick ; Tsai, Linda ; Papadatou, Eleni ; Alarcon, Aixa ; Vilupuru, Srividhya</author></sort><facets><frbrtype>5</frbrtype><frbrgroupid>cdi_FETCH-LOGICAL-c475t-d35cba884b518313d791eb4012ef364625778ee5e3aef4979c8e874e803e6d483</frbrgroupid><rsrctype>articles</rsrctype><prefilter>articles</prefilter><language>eng</language><creationdate>2024</creationdate><topic>692/308/409</topic><topic>692/699/3161/3168</topic><topic>Acuity</topic><topic>Aged</topic><topic>Contrast Sensitivity - physiology</topic><topic>Depth Perception - physiology</topic><topic>Double-Blind Method</topic><topic>Female</topic><topic>Humans</topic><topic>Intraocular lenses</topic><topic>Laboratory Medicine</topic><topic>Lens Implantation, Intraocular</topic><topic>Lenses, Intraocular</topic><topic>Male</topic><topic>Medicine</topic><topic>Medicine & Public Health</topic><topic>Middle Aged</topic><topic>Ophthalmology</topic><topic>Patient Satisfaction</topic><topic>Phacoemulsification</topic><topic>Pharmaceutical Sciences/Technology</topic><topic>Prospective Studies</topic><topic>Prosthesis Design</topic><topic>Pseudophakia - physiopathology</topic><topic>Refraction, Ocular - physiology</topic><topic>Surgery</topic><topic>Surgical Oncology</topic><topic>Vision</topic><topic>Visual acuity</topic><topic>Visual Acuity - physiology</topic><toplevel>peer_reviewed</toplevel><toplevel>online_resources</toplevel><creatorcontrib>Corbett, Dean</creatorcontrib><creatorcontrib>Black, Daniel</creatorcontrib><creatorcontrib>Roberts, Timothy V.</creatorcontrib><creatorcontrib>Cronin, Brendan</creatorcontrib><creatorcontrib>Gunn, David</creatorcontrib><creatorcontrib>Bala, Chandra</creatorcontrib><creatorcontrib>Versace, Patrick</creatorcontrib><creatorcontrib>Tsai, Linda</creatorcontrib><creatorcontrib>Papadatou, Eleni</creatorcontrib><creatorcontrib>Alarcon, Aixa</creatorcontrib><creatorcontrib>Vilupuru, Srividhya</creatorcontrib><collection>Springer Nature OA Free Journals</collection><collection>Medline</collection><collection>MEDLINE</collection><collection>MEDLINE (Ovid)</collection><collection>MEDLINE</collection><collection>MEDLINE</collection><collection>PubMed</collection><collection>CrossRef</collection><collection>Neurosciences Abstracts</collection><collection>ProQuest Health & Medical Complete (Alumni)</collection><collection>MEDLINE - Academic</collection><collection>PubMed Central (Full Participant titles)</collection><jtitle>Eye (London)</jtitle></facets><delivery><delcategory>Remote Search Resource</delcategory><fulltext>fulltext</fulltext></delivery><addata><au>Corbett, Dean</au><au>Black, Daniel</au><au>Roberts, Timothy V.</au><au>Cronin, Brendan</au><au>Gunn, David</au><au>Bala, Chandra</au><au>Versace, Patrick</au><au>Tsai, Linda</au><au>Papadatou, Eleni</au><au>Alarcon, Aixa</au><au>Vilupuru, Srividhya</au><format>journal</format><genre>article</genre><ristype>JOUR</ristype><atitle>Quality of vision clinical outcomes for a new fully-refractive extended depth of focus Intraocular Lens</atitle><jtitle>Eye (London)</jtitle><stitle>Eye</stitle><addtitle>Eye (Lond)</addtitle><date>2024-05-01</date><risdate>2024</risdate><volume>38</volume><issue>Suppl 1</issue><spage>9</spage><epage>14</epage><pages>9-14</pages><issn>0950-222X</issn><issn>1476-5454</issn><eissn>1476-5454</eissn><abstract>Background/objective
To evaluate the visual performance of a purely refractive extended depth of focus (EDF) intraocular lens (IOL).
Subjects/methods
A prospective, multi-center, randomized, subject/evaluator-masked study. Subjects were bilaterally implanted with the EDF test (Model ZEN00V, TECNIS PureSee™ IOL,
N
= 60) or an enhanced monofocal control (Model ICB00, TECNIS Eyhance™ IOL,
N
= 57) IOL. Monocular corrected distance (CDVA), intermediate (DCIVA), near acuities (DCNVA) and patient reported visual symptoms were evaluated at the 6-month visit. Monocular mesopic contrast sensitivity (CS) and depth of focus (DOF) testing were assessed at 3 months.
Results
CDVA (Mean ± SD) was −0.06 ± 0.08 for test and −0.05 ± 0.08 logMAR for control groups. DCIVA was 0.13 ± 0.08 for test and 0.18 ± 0.14 logMAR for control groups (
p
= 0.0127). DCNVA was 0.37 ± 0.10 for test and 0.43 ± 0.16 logMAR for control groups (
p
= 0.0137). Test lens was statistically superior for intermediate and near. Overall, 91.7% (halos), 95.0% (starbursts) and 95.0% (glare) of test lens patients reported that they did not experience, were not bothered, or were slightly bothered by specific visual symptoms, compared to 98.2%, 100% and 96.5% in the control group. The DOF range over which monocular visual acuity was 0.20 logMAR or better was −1.6 D for the test lens. Mesopic CS was comparable between both groups, falling within 0.11 log units for all measured cycles per degree with and without glare.
Conclusion
The EDF IOL demonstrated extended range of vision and statistically superior intermediate and near performance compared to the monofocal IOL. Distance visual acuity, contrast sensitivity and dysphotopsia profile were similar to the monofocal IOL.</abstract><cop>London</cop><pub>Nature Publishing Group UK</pub><pmid>38580741</pmid><doi>10.1038/s41433-024-03039-8</doi><tpages>6</tpages><orcidid>https://orcid.org/0000-0001-8056-927X</orcidid><orcidid>https://orcid.org/0000-0002-4443-8915</orcidid><orcidid>https://orcid.org/0000-0002-6288-0141</orcidid><orcidid>https://orcid.org/0009-0006-2011-0807</orcidid><oa>free_for_read</oa></addata></record> |
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source | MEDLINE; Alma/SFX Local Collection |
subjects | 692/308/409 692/699/3161/3168 Acuity Aged Contrast Sensitivity - physiology Depth Perception - physiology Double-Blind Method Female Humans Intraocular lenses Laboratory Medicine Lens Implantation, Intraocular Lenses, Intraocular Male Medicine Medicine & Public Health Middle Aged Ophthalmology Patient Satisfaction Phacoemulsification Pharmaceutical Sciences/Technology Prospective Studies Prosthesis Design Pseudophakia - physiopathology Refraction, Ocular - physiology Surgery Surgical Oncology Vision Visual acuity Visual Acuity - physiology |
title | Quality of vision clinical outcomes for a new fully-refractive extended depth of focus Intraocular Lens |
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