NCT04547036

Changes in Corneal Endothelial Cell Density After Transscleral ab Interno Glaucoma Gel Stent Implantation

• Status: Completed
• Phase: —
• Study type: Observational
• Enrollment: 129 (actual)
• Sponsor: Paracelsus Medical University · Academic / Other
• Sex: All
• Age: 18 Years
• Healthy volunteers: Accepted

Summary

The objective of this study is to evaluate the change of endothelial cell count after XEN45 in patients with or without cataract operation.

Detailed description

STUDY OBJECTIVE Corneal endothelial cell loss is a known sequela of glaucoma tube shunt implantation. Big tube shunts show a decrease of endothelial cell count postoperatively (-11.5% after Ahmed glaucoma valves and -12.4% after Molteno shunt 2 years postoperatively). The objective of this study is to evaluate the change of endothelial cell count after XEN45 in patients with or without cataract operation. PATIENT POPULATION In 140 open angle eyes central endothelial cell counts were recorded preoperatively, before the XEN45 implantation was performed in Dept. Ophthalmology at Paracelsus Medical University Salzburg. XEN45s were already performed in the year 2013-2017 (so up to 5 years) in open angle glaucoma eyes in combination with or without cataract operation. In these eyes central endothelial cell count and central corneal thickness was measured preoperatively and documented in patients records. STUDY DESIGN A prospective, observational, monocentric trial to evaluate the course of endothelial cell density after the XEN implant. The study will take place in the Dept. Ophthalmology at Paracelsus Medical University Salzburg/SALK. Up to 140 consecutive patients with preoperatively recorded endothelial cell counts will be summoned to a consecutive endothelial cell count record and measurement of central corneal thickness postoperatively. Informed consents will be obtained from patients, who are interested in participating in the study. Patients will be assessed for endothelial cell density and the position of the XEN45 measured by anterior segment optical coherence tomography. The distance of the XEN45 to cornea, the angle of the tube, and the tube length in the anterior chamber will be recorded with anterior segment optical coherence tomography. Endothelial cell density will be measured on 3 positions: central, superior-nasal (location of XEN45 implantation), infero-temporal (far away for the XEN45 implant). OUTCOME PARAMETERS The primary endpoint is the change of central endothelial cell density compared to preoperative data. Secondary objectives are the differences of supero-nasal and infero-temporal endothelial cell density compared to the central endothelial cell density, and pachymetry compared to preoperative data. EXAMINATION SCHEDULE Subjects will undergo study visits at the following times: preoperative data (2013-2017) out of patient records, postoperative visit in the year 2018-2020 (1-7 years post XEN45 implantation). CLINICAL PARAMETERS The following clinical assessments will be performed at the postoperative examination: 1. Endothelial cell count on different locations of the study eye 2. Central corneal thickness 3. Anterior segment optical coherence tomography (to determine the position of the XEN45) 4. Slit lamp examination of the cornea, anterior segment including gonioscopy (to determine the position of the XEN45), and dilated fundus examination 5. Best corrected visual acuity 6. Measurement of IOP 7. Number and frequency of ocular (glaucoma) medications 8. Ocular symptoms and assessment of complications (especially symptoms, which may be a hint for loss of endothelial cell count) 9. Secondary surgical procedures (if applicable including needlings, lasers, cataract operation, bleb revisions, keratoplasty, secondary IOP lowering procedures, other operations)

Conditions

• Glaucoma
• Endothelial Cell Loss, Corneal

Interventions

Type	Name	Description
DEVICE	XEN45	Up to 140 consecutive patients with preoperatively recorded endothelial cell counts will be summoned to a consecutive endothelial cell count record and measurement of central corneal thickness postoperatively.

Timeline

• Start date: 2020-01-30
• Primary completion: 2021-01-31
• Completion: 2021-04-30
• First posted: 2020-09-14
• Last updated: 2021-07-13
• Results posted: 2021-07-13

Locations

1 site across 1 country: Austria

Regulatory

• FDA-regulated device study