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Outcomes Following Implantation of Two Second-Generation Trabecular Micro-Bypass Stents in Patients with Open-Angle Glaucoma on One Medication: 18-Month Follow-Up

INTRODUCTION: The study objective was to evaluate the intraocular pressure (IOP) and medication-lowering effect of 2 second-generation trabecular micro-bypass stents in eyes with open-angle glaucoma (OAG) on one preoperative medication. METHODS: Fifty-seven qualified phakic eyes with OAG on 1 medica...

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Autores principales: Lindstrom, Richard, Lewis, Richard, Hornbeak, Dana M., Voskanyan, Lilit, Giamporcaro, Jane Ellen, Hovanesian, John, Sarkisian, Steven
Formato: Online Artículo Texto
Lenguaje:English
Publicado: Springer Healthcare 2016
Materias:
Acceso en línea:https://www.ncbi.nlm.nih.gov/pmc/articles/PMC5083781/
https://www.ncbi.nlm.nih.gov/pubmed/27739003
http://dx.doi.org/10.1007/s12325-016-0420-8
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author Lindstrom, Richard
Lewis, Richard
Hornbeak, Dana M.
Voskanyan, Lilit
Giamporcaro, Jane Ellen
Hovanesian, John
Sarkisian, Steven
author_facet Lindstrom, Richard
Lewis, Richard
Hornbeak, Dana M.
Voskanyan, Lilit
Giamporcaro, Jane Ellen
Hovanesian, John
Sarkisian, Steven
author_sort Lindstrom, Richard
collection PubMed
description INTRODUCTION: The study objective was to evaluate the intraocular pressure (IOP) and medication-lowering effect of 2 second-generation trabecular micro-bypass stents in eyes with open-angle glaucoma (OAG) on one preoperative medication. METHODS: Fifty-seven qualified phakic eyes with OAG on 1 medication, preoperative medicated IOP of 18–30 mmHg, and preoperative unmedicated (post-washout) IOP of 22–38 mmHg underwent implantation of 2 second-generation trabecular micro-bypass stents in a standalone procedure. Evaluations included IOP, best-corrected visual acuity, medication use, fundus and slit lamp examinations, visual field, cup to disc ratio, pachymetry, and complications and interventions. Subjects have been followed for 18 months, and follow-up is ongoing. RESULTS: At Month 12 postoperative, 100% of eyes had achieved an IOP reduction ≥20% (100% had IOP ≤18 mmHg and 67% had IOP ≤15 mmHg) without medication versus preoperative unmedicated IOP, and 75% had IOP reduction ≥20% without medication versus preoperative medicated IOP. The Month 12 mean unmedicated IOP had decreased by 42%, to 14.2 ± 1.9 mmHg vs 24.4 ± 1.3 mmHg preoperatively, and this reduction was maintained through 18 months (14.4 ± 2.1 mmHg). A high safety profile was observed. CONCLUSION: In this prospective, open-label, single-arm study, the standalone implantation of two second-generation trabecular micro-bypass stents in OAG patients on 1 preoperative medication resulted in IOP reduction to ≤15 mmHg and elimination of medication through 18 months, with favorable safety. TRIAL REGISTRATION: ClinicalTrials.gov identifier, NCT02868190. FUNDING: Glaukos Corporation, San Clemente, CA. ELECTRONIC SUPPLEMENTARY MATERIAL: The online version of this article (doi:10.1007/s12325-016-0420-8) contains supplementary material, which is available to authorized users.
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spelling pubmed-50837812016-11-14 Outcomes Following Implantation of Two Second-Generation Trabecular Micro-Bypass Stents in Patients with Open-Angle Glaucoma on One Medication: 18-Month Follow-Up Lindstrom, Richard Lewis, Richard Hornbeak, Dana M. Voskanyan, Lilit Giamporcaro, Jane Ellen Hovanesian, John Sarkisian, Steven Adv Ther Original Research INTRODUCTION: The study objective was to evaluate the intraocular pressure (IOP) and medication-lowering effect of 2 second-generation trabecular micro-bypass stents in eyes with open-angle glaucoma (OAG) on one preoperative medication. METHODS: Fifty-seven qualified phakic eyes with OAG on 1 medication, preoperative medicated IOP of 18–30 mmHg, and preoperative unmedicated (post-washout) IOP of 22–38 mmHg underwent implantation of 2 second-generation trabecular micro-bypass stents in a standalone procedure. Evaluations included IOP, best-corrected visual acuity, medication use, fundus and slit lamp examinations, visual field, cup to disc ratio, pachymetry, and complications and interventions. Subjects have been followed for 18 months, and follow-up is ongoing. RESULTS: At Month 12 postoperative, 100% of eyes had achieved an IOP reduction ≥20% (100% had IOP ≤18 mmHg and 67% had IOP ≤15 mmHg) without medication versus preoperative unmedicated IOP, and 75% had IOP reduction ≥20% without medication versus preoperative medicated IOP. The Month 12 mean unmedicated IOP had decreased by 42%, to 14.2 ± 1.9 mmHg vs 24.4 ± 1.3 mmHg preoperatively, and this reduction was maintained through 18 months (14.4 ± 2.1 mmHg). A high safety profile was observed. CONCLUSION: In this prospective, open-label, single-arm study, the standalone implantation of two second-generation trabecular micro-bypass stents in OAG patients on 1 preoperative medication resulted in IOP reduction to ≤15 mmHg and elimination of medication through 18 months, with favorable safety. TRIAL REGISTRATION: ClinicalTrials.gov identifier, NCT02868190. FUNDING: Glaukos Corporation, San Clemente, CA. ELECTRONIC SUPPLEMENTARY MATERIAL: The online version of this article (doi:10.1007/s12325-016-0420-8) contains supplementary material, which is available to authorized users. Springer Healthcare 2016-10-13 2016 /pmc/articles/PMC5083781/ /pubmed/27739003 http://dx.doi.org/10.1007/s12325-016-0420-8 Text en © The Author(s) 2016 https://creativecommons.org/licenses/by-nc/4.0/This article is distributed under the terms of the Creative Commons Attribution-NonCommercial 4.0 International License (http://creativecommons.org/licenses/by-nc/4.0/ (https://creativecommons.org/licenses/by-nc/4.0/) ), which permits any noncommercial use, distribution, and reproduction in any medium, provided you give appropriate credit to the original author(s) and the source, provide a link to the Creative Commons license, and indicate if changes were made.
spellingShingle Original Research
Lindstrom, Richard
Lewis, Richard
Hornbeak, Dana M.
Voskanyan, Lilit
Giamporcaro, Jane Ellen
Hovanesian, John
Sarkisian, Steven
Outcomes Following Implantation of Two Second-Generation Trabecular Micro-Bypass Stents in Patients with Open-Angle Glaucoma on One Medication: 18-Month Follow-Up
title Outcomes Following Implantation of Two Second-Generation Trabecular Micro-Bypass Stents in Patients with Open-Angle Glaucoma on One Medication: 18-Month Follow-Up
title_full Outcomes Following Implantation of Two Second-Generation Trabecular Micro-Bypass Stents in Patients with Open-Angle Glaucoma on One Medication: 18-Month Follow-Up
title_fullStr Outcomes Following Implantation of Two Second-Generation Trabecular Micro-Bypass Stents in Patients with Open-Angle Glaucoma on One Medication: 18-Month Follow-Up
title_full_unstemmed Outcomes Following Implantation of Two Second-Generation Trabecular Micro-Bypass Stents in Patients with Open-Angle Glaucoma on One Medication: 18-Month Follow-Up
title_short Outcomes Following Implantation of Two Second-Generation Trabecular Micro-Bypass Stents in Patients with Open-Angle Glaucoma on One Medication: 18-Month Follow-Up
title_sort outcomes following implantation of two second-generation trabecular micro-bypass stents in patients with open-angle glaucoma on one medication: 18-month follow-up
topic Original Research
url https://www.ncbi.nlm.nih.gov/pmc/articles/PMC5083781/
https://www.ncbi.nlm.nih.gov/pubmed/27739003
http://dx.doi.org/10.1007/s12325-016-0420-8
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