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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Veröffentlicht in:Eye (London) 2024-05, Vol.38 (Suppl 1), p.9-14
Hauptverfasser: Corbett, Dean, Black, Daniel, Roberts, Timothy V., Cronin, Brendan, Gunn, David, Bala, Chandra, Versace, Patrick, Tsai, Linda, Papadatou, Eleni, Alarcon, Aixa, Vilupuru, Srividhya
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container_end_page 14
container_issue Suppl 1
container_start_page 9
container_title Eye (London)
container_volume 38
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
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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 &amp; 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. 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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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1476-5454
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recordid cdi_pubmedcentral_primary_oai_pubmedcentral_nih_gov_11080637
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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