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A multicenter prospective comparative study evaluating cataract surgery and endoscopic cyclophotocoagulation either with or without iStent inject implantation in Brazilian patients with glaucoma
PURPOSE: Compare 12-month (12 M) safety and efficacy of endoscopic cyclophotocoagulation (ECP) + cataract surgery (Group 1) versus ECP + cataract surgery + iStent inject trabecular micro-bypass implantation (Group 2) in Brazilian patients with open-angle glaucoma (OAG). METHODS: This prospective, mu...
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Formato: | Online Artículo Texto |
Lenguaje: | English |
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Springer Netherlands
2022
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Materias: | |
Acceso en línea: | https://www.ncbi.nlm.nih.gov/pmc/articles/PMC10149466/ https://www.ncbi.nlm.nih.gov/pubmed/36273360 http://dx.doi.org/10.1007/s10792-022-02563-4 |
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author | Lima, Francisco E. Geraissate, João C. Ávila, Marcos P. |
author_facet | Lima, Francisco E. Geraissate, João C. Ávila, Marcos P. |
author_sort | Lima, Francisco E. |
collection | PubMed |
description | PURPOSE: Compare 12-month (12 M) safety and efficacy of endoscopic cyclophotocoagulation (ECP) + cataract surgery (Group 1) versus ECP + cataract surgery + iStent inject trabecular micro-bypass implantation (Group 2) in Brazilian patients with open-angle glaucoma (OAG). METHODS: This prospective, multicenter, comparative case series included patients with OAG and cataract who were randomized to receive treatment in Group 1 or Group 2. Outcomes included mean and percent reduction versus preoperative in intraocular pressure (IOP) and number of glaucoma medications; visual acuity; occurrence of adverse events; and rate of secondary surgeries. RESULTS: Preoperatively, Groups 1 and 2 had similar mean IOP (mean ± standard deviation 22.1 ± 3.6 and 22.0 ± 2.5 mmHg, respectively) and mean number of medications (3.3 ± 0.6 and 3.4 ± 0.6 medications, respectively). At all follow-up timepoints through 12 M, both groups achieved significant IOP and medication reductions versus preoperative (IOP p < 0.001 and number of medications p < 0.001 for both groups). At 12 M, IOP reductions were 24.2% (Group 1) and 43.6% (Group 2) (p < 0.001); mean medication reductions were 50.2% and 71.5%, respectively. Mean postoperative IOP and number of medications were higher in Group 1 than Group 2 (IOP p < 0.01 all visits, medication p < 0.01 at 6 M and 12 M). Adverse events were generally mild and infrequent in both groups. CONCLUSION: Both treatment groups (ECP + phacoemulsification, with/without iStent inject implantation) achieved significant and safe reductions in IOP and medications versus preoperative in Brazilian OAG patients. Percent reductions were significantly greater, and mean IOP and medications were significantly lower, in the group receiving iStent inject. CLINICAL TRIAL REGISTRATION (CTR): CAAE project identification #20053019.5.0000.5078. Protocol #3.587.147. Clinical Trial Database of the Federal University of Goiás, Brazil. Registration Date: September 19, 2019. SUPPLEMENTARY INFORMATION: The online version contains supplementary material available at 10.1007/s10792-022-02563-4. |
format | Online Article Text |
id | pubmed-10149466 |
institution | National Center for Biotechnology Information |
language | English |
publishDate | 2022 |
publisher | Springer Netherlands |
record_format | MEDLINE/PubMed |
spelling | pubmed-101494662023-05-02 A multicenter prospective comparative study evaluating cataract surgery and endoscopic cyclophotocoagulation either with or without iStent inject implantation in Brazilian patients with glaucoma Lima, Francisco E. Geraissate, João C. Ávila, Marcos P. Int Ophthalmol Original Paper PURPOSE: Compare 12-month (12 M) safety and efficacy of endoscopic cyclophotocoagulation (ECP) + cataract surgery (Group 1) versus ECP + cataract surgery + iStent inject trabecular micro-bypass implantation (Group 2) in Brazilian patients with open-angle glaucoma (OAG). METHODS: This prospective, multicenter, comparative case series included patients with OAG and cataract who were randomized to receive treatment in Group 1 or Group 2. Outcomes included mean and percent reduction versus preoperative in intraocular pressure (IOP) and number of glaucoma medications; visual acuity; occurrence of adverse events; and rate of secondary surgeries. RESULTS: Preoperatively, Groups 1 and 2 had similar mean IOP (mean ± standard deviation 22.1 ± 3.6 and 22.0 ± 2.5 mmHg, respectively) and mean number of medications (3.3 ± 0.6 and 3.4 ± 0.6 medications, respectively). At all follow-up timepoints through 12 M, both groups achieved significant IOP and medication reductions versus preoperative (IOP p < 0.001 and number of medications p < 0.001 for both groups). At 12 M, IOP reductions were 24.2% (Group 1) and 43.6% (Group 2) (p < 0.001); mean medication reductions were 50.2% and 71.5%, respectively. Mean postoperative IOP and number of medications were higher in Group 1 than Group 2 (IOP p < 0.01 all visits, medication p < 0.01 at 6 M and 12 M). Adverse events were generally mild and infrequent in both groups. CONCLUSION: Both treatment groups (ECP + phacoemulsification, with/without iStent inject implantation) achieved significant and safe reductions in IOP and medications versus preoperative in Brazilian OAG patients. Percent reductions were significantly greater, and mean IOP and medications were significantly lower, in the group receiving iStent inject. CLINICAL TRIAL REGISTRATION (CTR): CAAE project identification #20053019.5.0000.5078. Protocol #3.587.147. Clinical Trial Database of the Federal University of Goiás, Brazil. Registration Date: September 19, 2019. SUPPLEMENTARY INFORMATION: The online version contains supplementary material available at 10.1007/s10792-022-02563-4. Springer Netherlands 2022-10-23 2023 /pmc/articles/PMC10149466/ /pubmed/36273360 http://dx.doi.org/10.1007/s10792-022-02563-4 Text en © The Author(s) 2022 https://creativecommons.org/licenses/by/4.0/Open AccessThis article is licensed under a Creative Commons Attribution 4.0 International License, which permits use, sharing, adaptation, distribution and reproduction in any medium or format, as long as you give appropriate credit to the original author(s) and the source, provide a link to the Creative Commons licence, and indicate if changes were made. The images or other third party material in this article are included in the article's Creative Commons licence, unless indicated otherwise in a credit line to the material. If material is not included in the article's Creative Commons licence and your intended use is not permitted by statutory regulation or exceeds the permitted use, you will need to obtain permission directly from the copyright holder. To view a copy of this licence, visit http://creativecommons.org/licenses/by/4.0/ (https://creativecommons.org/licenses/by/4.0/) . |
spellingShingle | Original Paper Lima, Francisco E. Geraissate, João C. Ávila, Marcos P. A multicenter prospective comparative study evaluating cataract surgery and endoscopic cyclophotocoagulation either with or without iStent inject implantation in Brazilian patients with glaucoma |
title | A multicenter prospective comparative study evaluating cataract surgery and endoscopic cyclophotocoagulation either with or without iStent inject implantation in Brazilian patients with glaucoma |
title_full | A multicenter prospective comparative study evaluating cataract surgery and endoscopic cyclophotocoagulation either with or without iStent inject implantation in Brazilian patients with glaucoma |
title_fullStr | A multicenter prospective comparative study evaluating cataract surgery and endoscopic cyclophotocoagulation either with or without iStent inject implantation in Brazilian patients with glaucoma |
title_full_unstemmed | A multicenter prospective comparative study evaluating cataract surgery and endoscopic cyclophotocoagulation either with or without iStent inject implantation in Brazilian patients with glaucoma |
title_short | A multicenter prospective comparative study evaluating cataract surgery and endoscopic cyclophotocoagulation either with or without iStent inject implantation in Brazilian patients with glaucoma |
title_sort | multicenter prospective comparative study evaluating cataract surgery and endoscopic cyclophotocoagulation either with or without istent inject implantation in brazilian patients with glaucoma |
topic | Original Paper |
url | https://www.ncbi.nlm.nih.gov/pmc/articles/PMC10149466/ https://www.ncbi.nlm.nih.gov/pubmed/36273360 http://dx.doi.org/10.1007/s10792-022-02563-4 |
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