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Efficacy and Safety of the Preserflo Microshunt With Mitomycin C for the Treatment of Open Angle Glaucoma
PRÉCIS: The Preserflo Microshunt (PSM) is a safe and effective glaucoma microfiltering implant that significantly reduces the intraocular pressure (IOP), either alone or in combination with phacoemulsification, during the first year after surgery. PURPOSE: The purpose of this study was to assess the...
Autores principales: | , , , , |
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Formato: | Online Artículo Texto |
Lenguaje: | English |
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Lippincott Williams & Wilkins
2022
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Acceso en línea: | https://www.ncbi.nlm.nih.gov/pmc/articles/PMC9232283/ https://www.ncbi.nlm.nih.gov/pubmed/35583510 http://dx.doi.org/10.1097/IJG.0000000000002052 |
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author | Ibarz Barberá, Marta Martínez-Galdón, Fátima Caballero-Magro, Elena Rodríguez-Piñero, Marta Tañá-Rivero, Pedro |
author_facet | Ibarz Barberá, Marta Martínez-Galdón, Fátima Caballero-Magro, Elena Rodríguez-Piñero, Marta Tañá-Rivero, Pedro |
author_sort | Ibarz Barberá, Marta |
collection | PubMed |
description | PRÉCIS: The Preserflo Microshunt (PSM) is a safe and effective glaucoma microfiltering implant that significantly reduces the intraocular pressure (IOP), either alone or in combination with phacoemulsification, during the first year after surgery. PURPOSE: The purpose of this study was to assess the safety and efficacy of the PSM for the treatment of open angle glaucoma with 0.2 mg/mL mitomycin C, either alone or in combination with cataract surgery. METHODS: A retrospective, open-label study of 64 eyes with primary open angle glaucoma that underwent PSM implantation and were followed up for at least 9 months. Success was defined as IOP 6–17 mm Hg and a reduction of at least 20%, complete without hypotensive medication, and qualified with medication. Safety was assessed by the incidence of adverse events. Secondary endpoints included mean hypotensive medications, visual acuity, and incidence of needling and surgical revision. RESULTS: A total of 51 eyes underwent PSM alone and 13 underwent PSM+phacoemulsification. In the overall population of the study, the mean IOP was significantly reduced from 22.03±0.7 mm Hg at baseline to 12.7±0.4 mm Hg at the final visit, P<0.0001 (mean follow-up: 11±1.4 mo). The IOP was significantly reduced in both groups (P<0.0001). Ocular hypotensive medication was reduced significantly from 2.7±0.7 to 0.2±0.5 (P<0.0001). No significant differences were found in IOP-lowering medication between groups (PSM alone, 0.2±0.08; PSM+phacoemulsification, 0.1±0.1; P=0.2). At the final visit, 70.3% were considered as complete success and 12.5% as qualified success. The most common adverse event was clinical hypotony (7.8%) followed by hyphema (4.7%), and anterior chamber reformation (1.6%). Overall, 1.6% required needling and 15.6% surgical revision to restore the flow. CONCLUSION: Glaucoma surgery with the PSM and mitomycin C was efficacious and safe in the short term, either alone or in combination with cataract surgery, and may be considered a surgical option for lowering IOP in primary open angle glaucoma. |
format | Online Article Text |
id | pubmed-9232283 |
institution | National Center for Biotechnology Information |
language | English |
publishDate | 2022 |
publisher | Lippincott Williams & Wilkins |
record_format | MEDLINE/PubMed |
spelling | pubmed-92322832022-07-01 Efficacy and Safety of the Preserflo Microshunt With Mitomycin C for the Treatment of Open Angle Glaucoma Ibarz Barberá, Marta Martínez-Galdón, Fátima Caballero-Magro, Elena Rodríguez-Piñero, Marta Tañá-Rivero, Pedro J Glaucoma New Glaucoma Insights: Original Studies PRÉCIS: The Preserflo Microshunt (PSM) is a safe and effective glaucoma microfiltering implant that significantly reduces the intraocular pressure (IOP), either alone or in combination with phacoemulsification, during the first year after surgery. PURPOSE: The purpose of this study was to assess the safety and efficacy of the PSM for the treatment of open angle glaucoma with 0.2 mg/mL mitomycin C, either alone or in combination with cataract surgery. METHODS: A retrospective, open-label study of 64 eyes with primary open angle glaucoma that underwent PSM implantation and were followed up for at least 9 months. Success was defined as IOP 6–17 mm Hg and a reduction of at least 20%, complete without hypotensive medication, and qualified with medication. Safety was assessed by the incidence of adverse events. Secondary endpoints included mean hypotensive medications, visual acuity, and incidence of needling and surgical revision. RESULTS: A total of 51 eyes underwent PSM alone and 13 underwent PSM+phacoemulsification. In the overall population of the study, the mean IOP was significantly reduced from 22.03±0.7 mm Hg at baseline to 12.7±0.4 mm Hg at the final visit, P<0.0001 (mean follow-up: 11±1.4 mo). The IOP was significantly reduced in both groups (P<0.0001). Ocular hypotensive medication was reduced significantly from 2.7±0.7 to 0.2±0.5 (P<0.0001). No significant differences were found in IOP-lowering medication between groups (PSM alone, 0.2±0.08; PSM+phacoemulsification, 0.1±0.1; P=0.2). At the final visit, 70.3% were considered as complete success and 12.5% as qualified success. The most common adverse event was clinical hypotony (7.8%) followed by hyphema (4.7%), and anterior chamber reformation (1.6%). Overall, 1.6% required needling and 15.6% surgical revision to restore the flow. CONCLUSION: Glaucoma surgery with the PSM and mitomycin C was efficacious and safe in the short term, either alone or in combination with cataract surgery, and may be considered a surgical option for lowering IOP in primary open angle glaucoma. Lippincott Williams & Wilkins 2022-07 2022-05-17 /pmc/articles/PMC9232283/ /pubmed/35583510 http://dx.doi.org/10.1097/IJG.0000000000002052 Text en Copyright © 2022 The Author(s). Published by Wolters Kluwer Health, Inc. https://creativecommons.org/licenses/by-nc-nd/4.0/This is an open access article distributed under the terms of the Creative Commons Attribution-Non Commercial-No Derivatives License 4.0 (https://creativecommons.org/licenses/by-nc-nd/4.0/) (CCBY-NC-ND), where it is permissible to download and share the work provided it is properly cited. The work cannot be changed in any way or used commercially without permission from the journal. http://creativecommons.org/licenses/by-nc-nd/4.0/ (https://creativecommons.org/licenses/by-nc-nd/4.0/) |
spellingShingle | New Glaucoma Insights: Original Studies Ibarz Barberá, Marta Martínez-Galdón, Fátima Caballero-Magro, Elena Rodríguez-Piñero, Marta Tañá-Rivero, Pedro Efficacy and Safety of the Preserflo Microshunt With Mitomycin C for the Treatment of Open Angle Glaucoma |
title | Efficacy and Safety of the Preserflo Microshunt With Mitomycin C for the Treatment of Open Angle Glaucoma |
title_full | Efficacy and Safety of the Preserflo Microshunt With Mitomycin C for the Treatment of Open Angle Glaucoma |
title_fullStr | Efficacy and Safety of the Preserflo Microshunt With Mitomycin C for the Treatment of Open Angle Glaucoma |
title_full_unstemmed | Efficacy and Safety of the Preserflo Microshunt With Mitomycin C for the Treatment of Open Angle Glaucoma |
title_short | Efficacy and Safety of the Preserflo Microshunt With Mitomycin C for the Treatment of Open Angle Glaucoma |
title_sort | efficacy and safety of the preserflo microshunt with mitomycin c for the treatment of open angle glaucoma |
topic | New Glaucoma Insights: Original Studies |
url | https://www.ncbi.nlm.nih.gov/pmc/articles/PMC9232283/ https://www.ncbi.nlm.nih.gov/pubmed/35583510 http://dx.doi.org/10.1097/IJG.0000000000002052 |
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