Complications and post-operative interventions in XEN45 gel stent implantation in the treatment of open angle glaucoma-a systematic review and meta-analysis
© 2022. The Author(s), under exclusive licence to The Royal College of Ophthalmologists..
BACKGROUND: The XEN45 Gel Stent is a subconjunctival filtering device that has demonstrated promising efficacy. This meta-analysis quantitatively evaluates reported complications and interventions after XEN45 implantation in the treatment of open angle glaucoma (OAG).
METHODS: Pilot, cohort, observational studies, and randomised controlled trials that included at least ten patients undergoing ab interno or externo XEN45 surgery, with or without phacoemulsification were deemed eligible for inclusion. A meta-analysis of proportions with random-effect models was performed using the meta routine in R version 3.2.1. Outcomes included the rate of complications and post-operative interventions.
RESULTS: One hundred and fifty-two studies were identified on initial literature search and 33 were included in final analysis. Numerical hypotony was the most common post-operative complication, involving 20% of patients (95% CI: 10-31%). Post-operative gross hyphema occurred in 14% (95% CI: 7-22%) and transient intra-ocular pressure (IOP) spikes (>30 mmHg) in 13% (95% CI: 4-27%). Stent exposure occurred in 1% (95% CI: 0-2%). Stent migration occurred in 1% (95% CI: 0-3%). XEN45 revision and/or a second XEN45 implantation was performed in 5% of patients (95% CI: 3-7%). Stent relocation was performed in 3% (95% CI: 1-7%). A second glaucoma procedure was performed in 11% (95% CI: 8-15%). 26% underwent one (95% CI: 17-36%), 13% underwent two (95% CI: 5-24%) while 4% underwent three (95% CI: 2-6%) bleb needling procedures. 35% of patients (95% CI: 29-40%) required at least one needling. The average rate of needling per patient was 0.38 (95% CI: 0.20-0.59). However, there is a lack of high-quality data, with 8 of the 33 studies assessed to have a moderate to high risk of bias.
CONCLUSIONS: While literature suggests that XEN45 Gel Stent implantation is safe in the treatment of OAG, the overall current level of evidence is low and further studies are needed. More than a third of patients require at least one post-operative bleb needling procedure.
Errataetall: |
CommentOn: Am J Ophthalmol. 2017 Nov;183:25-36. - PMID 28784554 |
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Medienart: |
E-Artikel |
Erscheinungsjahr: |
2023 |
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Erschienen: |
2023 |
Enthalten in: |
Zur Gesamtaufnahme - volume:37 |
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Enthalten in: |
Eye (London, England) - 37(2023), 6 vom: 07. Apr., Seite 1047-1060 |
Sprache: |
Englisch |
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Beteiligte Personen: |
Betzler, Bjorn Kaijun [VerfasserIn] |
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Anmerkungen: |
Date Completed 17.04.2023 Date Revised 02.04.2024 published: Print-Electronic CommentOn: Am J Ophthalmol. 2017 Nov;183:25-36. - PMID 28784554 Citation Status MEDLINE |
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doi: |
10.1038/s41433-022-02022-5 |
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funding: |
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PPN (Katalog-ID): |
NLM338774254 |
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520 | |a © 2022. The Author(s), under exclusive licence to The Royal College of Ophthalmologists. | ||
520 | |a BACKGROUND: The XEN45 Gel Stent is a subconjunctival filtering device that has demonstrated promising efficacy. This meta-analysis quantitatively evaluates reported complications and interventions after XEN45 implantation in the treatment of open angle glaucoma (OAG) | ||
520 | |a METHODS: Pilot, cohort, observational studies, and randomised controlled trials that included at least ten patients undergoing ab interno or externo XEN45 surgery, with or without phacoemulsification were deemed eligible for inclusion. A meta-analysis of proportions with random-effect models was performed using the meta routine in R version 3.2.1. Outcomes included the rate of complications and post-operative interventions | ||
520 | |a RESULTS: One hundred and fifty-two studies were identified on initial literature search and 33 were included in final analysis. Numerical hypotony was the most common post-operative complication, involving 20% of patients (95% CI: 10-31%). Post-operative gross hyphema occurred in 14% (95% CI: 7-22%) and transient intra-ocular pressure (IOP) spikes (>30 mmHg) in 13% (95% CI: 4-27%). Stent exposure occurred in 1% (95% CI: 0-2%). Stent migration occurred in 1% (95% CI: 0-3%). XEN45 revision and/or a second XEN45 implantation was performed in 5% of patients (95% CI: 3-7%). Stent relocation was performed in 3% (95% CI: 1-7%). A second glaucoma procedure was performed in 11% (95% CI: 8-15%). 26% underwent one (95% CI: 17-36%), 13% underwent two (95% CI: 5-24%) while 4% underwent three (95% CI: 2-6%) bleb needling procedures. 35% of patients (95% CI: 29-40%) required at least one needling. The average rate of needling per patient was 0.38 (95% CI: 0.20-0.59). However, there is a lack of high-quality data, with 8 of the 33 studies assessed to have a moderate to high risk of bias | ||
520 | |a CONCLUSIONS: While literature suggests that XEN45 Gel Stent implantation is safe in the treatment of OAG, the overall current level of evidence is low and further studies are needed. More than a third of patients require at least one post-operative bleb needling procedure | ||
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