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Twelve-Months Follow-Up Postmarket Study of a Hydrophobic Intraocular Lens Using a Preloaded Automated Injector in an Indian Population

PURPOSE: To assess real-world clinical outcomes and safety of the Clareon(®) intraocular lens (IOL) and AutonoMe(®) automated preloaded delivery system in an Indian population. PATIENTS AND METHODS: This was a prospective, single-arm, multicenter, 12-month clinical study in patients aged ≥20 years w...

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Autores principales: Titiyal, Jeewan S, Basak, Samar K, Shetty, Naren, Mathur, Umang, Padmanabhan, Prema, Ganesh, Sri, Dey, Arindam, Ramamurthy, Dandapani
Formato: Online Artículo Texto
Lenguaje:English
Publicado: Dove 2022
Materias:
Acceso en línea:https://www.ncbi.nlm.nih.gov/pmc/articles/PMC9767064/
https://www.ncbi.nlm.nih.gov/pubmed/36561374
http://dx.doi.org/10.2147/OPTH.S379054
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author Titiyal, Jeewan S
Basak, Samar K
Shetty, Naren
Mathur, Umang
Padmanabhan, Prema
Ganesh, Sri
Dey, Arindam
Ramamurthy, Dandapani
author_facet Titiyal, Jeewan S
Basak, Samar K
Shetty, Naren
Mathur, Umang
Padmanabhan, Prema
Ganesh, Sri
Dey, Arindam
Ramamurthy, Dandapani
author_sort Titiyal, Jeewan S
collection PubMed
description PURPOSE: To assess real-world clinical outcomes and safety of the Clareon(®) intraocular lens (IOL) and AutonoMe(®) automated preloaded delivery system in an Indian population. PATIENTS AND METHODS: This was a prospective, single-arm, multicenter, 12-month clinical study in patients aged ≥20 years with unilateral or bilateral cataracts. Surgery was performed by phacoemulsification followed by implantation of the Clareon monofocal IOL (CNA0T0). Monocular best-corrected distance visual acuity (BCDVA) and uncorrected distance visual acuity (UCDVA) were assessed at 1 week and 1, 6, and 12 months after implantation. Posterior capsular opacification (PCO), surface haze, and glistenings were evaluated at all visits. Surgeons’ satisfaction with automated injector system was also evaluated using a questionnaire. Safety was assessed by monitoring adverse events (AEs). RESULTS: A total of 151 eyes received the CNA0T0 IOL. Mean ± SD monocular BCDVA improved from 0.53±0.44 logMAR preoperatively to 0.00±0.08 logMAR at week 1 and −0.03±0.08 logMAR at 12 months after implantation. At 12 months, 137/137 (100%) of eyes achieved BCDVA of 0.3 logMAR or better. Mean ± SD monocular UCDVA was 0.78±0.40 logMAR preoperatively, 0.11±0.15 logMAR at week 1, and 0.08±0.13 logMAR at 12 months after implantation. At 12 months, 132/137 (96%) eyes achieved UCDVA of 0.3 logMAR or better. Serious intraoperative AEs were posterior capsule rupture (n=1) and ciliary zonular dehiscence (n=1). Surgeons reported that the automated preloaded device was more intuitive compared with other push- or screw-style preloaded injector systems. None of the eyes in this study presented surface haze; all were graded as 0 glistenings at all visits. No clinically significant PCO or neodymium-doped yttrium aluminum garnet (Nd:YAG) capsulotomies were reported. CONCLUSION: The hydrophobic IOL preloaded in an automated injector system provided good visual and refractive outcomes, as well as no surface haze and grade 0 glistenings. None of the patients required Nd:YAG capsulotomy.
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spelling pubmed-97670642022-12-21 Twelve-Months Follow-Up Postmarket Study of a Hydrophobic Intraocular Lens Using a Preloaded Automated Injector in an Indian Population Titiyal, Jeewan S Basak, Samar K Shetty, Naren Mathur, Umang Padmanabhan, Prema Ganesh, Sri Dey, Arindam Ramamurthy, Dandapani Clin Ophthalmol Clinical Trial Report PURPOSE: To assess real-world clinical outcomes and safety of the Clareon(®) intraocular lens (IOL) and AutonoMe(®) automated preloaded delivery system in an Indian population. PATIENTS AND METHODS: This was a prospective, single-arm, multicenter, 12-month clinical study in patients aged ≥20 years with unilateral or bilateral cataracts. Surgery was performed by phacoemulsification followed by implantation of the Clareon monofocal IOL (CNA0T0). Monocular best-corrected distance visual acuity (BCDVA) and uncorrected distance visual acuity (UCDVA) were assessed at 1 week and 1, 6, and 12 months after implantation. Posterior capsular opacification (PCO), surface haze, and glistenings were evaluated at all visits. Surgeons’ satisfaction with automated injector system was also evaluated using a questionnaire. Safety was assessed by monitoring adverse events (AEs). RESULTS: A total of 151 eyes received the CNA0T0 IOL. Mean ± SD monocular BCDVA improved from 0.53±0.44 logMAR preoperatively to 0.00±0.08 logMAR at week 1 and −0.03±0.08 logMAR at 12 months after implantation. At 12 months, 137/137 (100%) of eyes achieved BCDVA of 0.3 logMAR or better. Mean ± SD monocular UCDVA was 0.78±0.40 logMAR preoperatively, 0.11±0.15 logMAR at week 1, and 0.08±0.13 logMAR at 12 months after implantation. At 12 months, 132/137 (96%) eyes achieved UCDVA of 0.3 logMAR or better. Serious intraoperative AEs were posterior capsule rupture (n=1) and ciliary zonular dehiscence (n=1). Surgeons reported that the automated preloaded device was more intuitive compared with other push- or screw-style preloaded injector systems. None of the eyes in this study presented surface haze; all were graded as 0 glistenings at all visits. No clinically significant PCO or neodymium-doped yttrium aluminum garnet (Nd:YAG) capsulotomies were reported. CONCLUSION: The hydrophobic IOL preloaded in an automated injector system provided good visual and refractive outcomes, as well as no surface haze and grade 0 glistenings. None of the patients required Nd:YAG capsulotomy. Dove 2022-12-16 /pmc/articles/PMC9767064/ /pubmed/36561374 http://dx.doi.org/10.2147/OPTH.S379054 Text en © 2022 Titiyal 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 Clinical Trial Report
Titiyal, Jeewan S
Basak, Samar K
Shetty, Naren
Mathur, Umang
Padmanabhan, Prema
Ganesh, Sri
Dey, Arindam
Ramamurthy, Dandapani
Twelve-Months Follow-Up Postmarket Study of a Hydrophobic Intraocular Lens Using a Preloaded Automated Injector in an Indian Population
title Twelve-Months Follow-Up Postmarket Study of a Hydrophobic Intraocular Lens Using a Preloaded Automated Injector in an Indian Population
title_full Twelve-Months Follow-Up Postmarket Study of a Hydrophobic Intraocular Lens Using a Preloaded Automated Injector in an Indian Population
title_fullStr Twelve-Months Follow-Up Postmarket Study of a Hydrophobic Intraocular Lens Using a Preloaded Automated Injector in an Indian Population
title_full_unstemmed Twelve-Months Follow-Up Postmarket Study of a Hydrophobic Intraocular Lens Using a Preloaded Automated Injector in an Indian Population
title_short Twelve-Months Follow-Up Postmarket Study of a Hydrophobic Intraocular Lens Using a Preloaded Automated Injector in an Indian Population
title_sort twelve-months follow-up postmarket study of a hydrophobic intraocular lens using a preloaded automated injector in an indian population
topic Clinical Trial Report
url https://www.ncbi.nlm.nih.gov/pmc/articles/PMC9767064/
https://www.ncbi.nlm.nih.gov/pubmed/36561374
http://dx.doi.org/10.2147/OPTH.S379054
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