N/A
Completed N=129
Changes in Corneal Endothelial Cell Density After Transscleral ab Interno Glaucoma Gel Stent Implantation
Glaucoma · Endothelial Cell Loss, Corneal
Source: ClinicalTrials.gov NCT04547036 ↗
Enrolled (actual)
129
Serious AEs
0.0%
Results posted
Jul 2021
Primary outcomePrimary: Endothelial Cell Count Change — 2; -1; 0; -4 % change compared to baseline
Summary
The objective of this study is to evaluate the change of endothelial cell count after XEN45 in patients with or without cataract operation.
Outcome Measures
| Outcome | Result | p-value |
|---|---|---|
| PRIMARY Endothelial Cell Count Change |
2; -1; 0; -4; -1 | — |
Eligibility Criteria
Inclusion Criteria
- Open Angle Glaucoma
- History past XEN45 implantation with or without combined cataract procedure
- Available preoperative endothelial cell count data not older than 1 year before XEN operation without any operation between the day of data record and XEN45 operation.
- Age 18 years or older and of legal age of consent
- Signed written informed consent
- Availability, willingness, and sufficient cognitive awareness to comply with examination procedures
Exclusion Criteria
- Patients with secondary IOP lowering procedures (excluding SLT, needlings, bleb revisions, YAG lasers, Argon lasers) after XEN implantation will be excluded from analysis, because the secondary IOP lowering procedures may influence endothelial cell count itself. Cataract operations without complications are no exclusion criteria, but have to be recorded.
Data sourced from ClinicalTrials.gov (NCT04547036). 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.