N/A
Completed N=174
Chart Review of XEN 45 Gel Stent: Long Term Performance and Safety Assessment (XEN LT)
Source: ClinicalTrials.gov NCT03868254 ↗Enrolled (actual)
174
Serious AEs
1.2%
Results posted
Nov 2020
Primary outcomePrimary: Change From Baseline in Mean Intraocular Pressure (IOP) to 36 Months After Implantation — 21.03; 20.21; -6.42; -6.73 mm Hg — p=<.0001
Summary
A retrospective, non-interventional, observational, multi-center, chart review study to be conducted in participants who underwent placement of the XEN 45 Gel Stent as a standalone procedure or in combination with phacoemulsification from 1 January 2014 to 1 October 2015.
Outcome Measures
| Outcome | Result | p-value |
|---|---|---|
| PRIMARY Change From Baseline in Mean Intraocular Pressure (IOP) to 36 Months After Implantation |
21.03; 20.21; -6.42; -6.73 | <.0001 sig |
| PRIMARY Change From Baseline in the Number of Topical IOP-lowering Medications 36 Months After Implantation |
2.6; 2.4; -1.6; -1.2 | <.0001 sig |
| SECONDARY Change From Baseline in Mean IOP to 48 Months After Implantation |
21.03; 20.21; -5.46; -5.27 | 0.0030 sig |
| SECONDARY Change From Baseline in the Number of Topical IOP-lowering Medications 48 Months After Implantation |
2.6; 2.4; -1.1; -0.8 | 0.0053 sig |
| SECONDARY Percentage of Eyes Achieving Qualified Success at Month 36 |
23.9; 40.0 | — |
| SECONDARY Percentage of Eyes Achieving Qualified Success at Month 48 |
25.0; 33.3 | — |
| SECONDARY Percentage of Eyes Achieving Complete Success at Month 36 |
45.7; 20.0 | — |
| SECONDARY Percentage of Eyes Achieving Complete Success at Month 48 |
33.3; 20.0 | — |
| SECONDARY Percentage of Eyes With Adverse Events of Special Interest (AESIs) |
18.1; 10.4 | — |
Eligibility Criteria
Inclusion Criteria
- Eye treated with XEN 45 Gel Stent for primary open angle glaucoma as a standalone procedure or in combination with phacoemulsification
- XEN 45 Gel Stent was implanted between 1 January 2014 and 1 October 2015
Exclusion Criteria
- None
Data sourced from ClinicalTrials.gov (NCT03868254). Outcome figures and adverse-event rates are extracted automatically from the registry's posted results and are provided for clinician reference, not as a substitute for the primary publication. Informational only — not medical advice.