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Clinical Outcomes After Bilateral Implantation of a Diffractive Trifocal Intraocular Lens: A Worldwide Pooled Analysis of Prospective Clinical Investigations

PURPOSE: To investigate visual and safety outcomes of AcrySof(®) IQ PanOptix(®) (model TFNT00), a trifocal, presbyopia-correcting intraocular lens (IOL), in patients of different ethnicities across multiple countries, based on a pooled analysis of six prospective multicenter studies. PATIENTS AND ME...

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Autores principales: Kohnen, Thomas, Lapid-Gortzak, Ruth, Ramamurthy, Dandapani, Bissen-Miyajima, Hiroko, Maxwell, Andrew, Kim, Tae-Im, Modi, Satish
Formato: Online Artículo Texto
Lenguaje:English
Publicado: Dove 2023
Materias:
Acceso en línea:https://www.ncbi.nlm.nih.gov/pmc/articles/PMC9840399/
https://www.ncbi.nlm.nih.gov/pubmed/36647516
http://dx.doi.org/10.2147/OPTH.S377234
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author Kohnen, Thomas
Lapid-Gortzak, Ruth
Ramamurthy, Dandapani
Bissen-Miyajima, Hiroko
Maxwell, Andrew
Kim, Tae-Im
Modi, Satish
author_facet Kohnen, Thomas
Lapid-Gortzak, Ruth
Ramamurthy, Dandapani
Bissen-Miyajima, Hiroko
Maxwell, Andrew
Kim, Tae-Im
Modi, Satish
author_sort Kohnen, Thomas
collection PubMed
description PURPOSE: To investigate visual and safety outcomes of AcrySof(®) IQ PanOptix(®) (model TFNT00), a trifocal, presbyopia-correcting intraocular lens (IOL), in patients of different ethnicities across multiple countries, based on a pooled analysis of six prospective multicenter studies. PATIENTS AND METHODS: This pooled analysis included adult patients from six prospective clinical studies performed across 56 centers worldwide. After cataract removal by phacoemulsification, all patients were implanted with TFNT00; follow-up duration varied from 3 to 12 months according to the studies’ design. Binocular defocus curve; absolute manifest refraction spherical equivalent (MRSE); and binocular photopic uncorrected and corrected visual acuities at distance (UCDVA, BCDVA; 4–5 m), intermediate (UCIVA, DCIVA; 60–66 cm), and near (UCNVA, DCNVA; 40 cm) were measured. RESULTS: The study included 557 patients, 547 of whom were implanted bilaterally with the TFNT00 IOL (n = 1094 eyes). Binocular visual data at 1 month and 3–6 months after implantation were available for up to 546 and 542 bilaterally implanted patients, respectively. A continuous range of 0.1 logarithm of the minimum angle of resolution (logMAR) or better vision from distance (0.00 diopter [D], 4–5 m) to near (–3.00 D; optically equivalent to 33 cm) was observed 3–6 months after TFNT00 implantation. At 3–6 months, 88.2% of first eyes achieved an MRSE ≤0.50 D and 88.7% of second eyes achieved an MRSE ≤0.50 D. Overall, 99.3%, 92.3%, and 94.6% of patients bilaterally implanted with TFNT00 achieved binocular photopic BCDVA, DCIVA, and DCNVA of 0.14 logMAR or better, respectively. Ocular adverse device effects and secondary surgical interventions (SSIs) were infrequent. CONCLUSION: This global pooled analysis showed that TFNT00 provided a continuous range of 0.1 logMAR (~20/25 Snellen) or better vision from distance to 33 cm, with a low incidence of ocular adverse device effects and SSIs.
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spelling pubmed-98403992023-01-15 Clinical Outcomes After Bilateral Implantation of a Diffractive Trifocal Intraocular Lens: A Worldwide Pooled Analysis of Prospective Clinical Investigations Kohnen, Thomas Lapid-Gortzak, Ruth Ramamurthy, Dandapani Bissen-Miyajima, Hiroko Maxwell, Andrew Kim, Tae-Im Modi, Satish Clin Ophthalmol Original Research PURPOSE: To investigate visual and safety outcomes of AcrySof(®) IQ PanOptix(®) (model TFNT00), a trifocal, presbyopia-correcting intraocular lens (IOL), in patients of different ethnicities across multiple countries, based on a pooled analysis of six prospective multicenter studies. PATIENTS AND METHODS: This pooled analysis included adult patients from six prospective clinical studies performed across 56 centers worldwide. After cataract removal by phacoemulsification, all patients were implanted with TFNT00; follow-up duration varied from 3 to 12 months according to the studies’ design. Binocular defocus curve; absolute manifest refraction spherical equivalent (MRSE); and binocular photopic uncorrected and corrected visual acuities at distance (UCDVA, BCDVA; 4–5 m), intermediate (UCIVA, DCIVA; 60–66 cm), and near (UCNVA, DCNVA; 40 cm) were measured. RESULTS: The study included 557 patients, 547 of whom were implanted bilaterally with the TFNT00 IOL (n = 1094 eyes). Binocular visual data at 1 month and 3–6 months after implantation were available for up to 546 and 542 bilaterally implanted patients, respectively. A continuous range of 0.1 logarithm of the minimum angle of resolution (logMAR) or better vision from distance (0.00 diopter [D], 4–5 m) to near (–3.00 D; optically equivalent to 33 cm) was observed 3–6 months after TFNT00 implantation. At 3–6 months, 88.2% of first eyes achieved an MRSE ≤0.50 D and 88.7% of second eyes achieved an MRSE ≤0.50 D. Overall, 99.3%, 92.3%, and 94.6% of patients bilaterally implanted with TFNT00 achieved binocular photopic BCDVA, DCIVA, and DCNVA of 0.14 logMAR or better, respectively. Ocular adverse device effects and secondary surgical interventions (SSIs) were infrequent. CONCLUSION: This global pooled analysis showed that TFNT00 provided a continuous range of 0.1 logMAR (~20/25 Snellen) or better vision from distance to 33 cm, with a low incidence of ocular adverse device effects and SSIs. Dove 2023-01-10 /pmc/articles/PMC9840399/ /pubmed/36647516 http://dx.doi.org/10.2147/OPTH.S377234 Text en © 2023 Kohnen et al. https://creativecommons.org/licenses/by-nc/3.0/This work is published and licensed by Dove Medical Press Limited. The full terms of this license are available at https://www.dovepress.com/terms.php and incorporate the Creative Commons Attribution – Non Commercial (unported, v3.0) License (http://creativecommons.org/licenses/by-nc/3.0/ (https://creativecommons.org/licenses/by-nc/3.0/) ). By accessing the work you hereby accept the Terms. Non-commercial uses of the work are permitted without any further permission from Dove Medical Press Limited, provided the work is properly attributed. For permission for commercial use of this work, please see paragraphs 4.2 and 5 of our Terms (https://www.dovepress.com/terms.php).
spellingShingle Original Research
Kohnen, Thomas
Lapid-Gortzak, Ruth
Ramamurthy, Dandapani
Bissen-Miyajima, Hiroko
Maxwell, Andrew
Kim, Tae-Im
Modi, Satish
Clinical Outcomes After Bilateral Implantation of a Diffractive Trifocal Intraocular Lens: A Worldwide Pooled Analysis of Prospective Clinical Investigations
title Clinical Outcomes After Bilateral Implantation of a Diffractive Trifocal Intraocular Lens: A Worldwide Pooled Analysis of Prospective Clinical Investigations
title_full Clinical Outcomes After Bilateral Implantation of a Diffractive Trifocal Intraocular Lens: A Worldwide Pooled Analysis of Prospective Clinical Investigations
title_fullStr Clinical Outcomes After Bilateral Implantation of a Diffractive Trifocal Intraocular Lens: A Worldwide Pooled Analysis of Prospective Clinical Investigations
title_full_unstemmed Clinical Outcomes After Bilateral Implantation of a Diffractive Trifocal Intraocular Lens: A Worldwide Pooled Analysis of Prospective Clinical Investigations
title_short Clinical Outcomes After Bilateral Implantation of a Diffractive Trifocal Intraocular Lens: A Worldwide Pooled Analysis of Prospective Clinical Investigations
title_sort clinical outcomes after bilateral implantation of a diffractive trifocal intraocular lens: a worldwide pooled analysis of prospective clinical investigations
topic Original Research
url https://www.ncbi.nlm.nih.gov/pmc/articles/PMC9840399/
https://www.ncbi.nlm.nih.gov/pubmed/36647516
http://dx.doi.org/10.2147/OPTH.S377234
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