Clinical Trial Details
— Status: Completed
Administrative data
NCT number |
NCT04547036 |
Other study ID # |
0010152018 |
Secondary ID |
|
Status |
Completed |
Phase |
|
First received |
|
Last updated |
|
Start date |
January 30, 2020 |
Est. completion date |
April 30, 2021 |
Study information
Verified date |
July 2021 |
Source |
Paracelsus Medical University |
Contact |
n/a |
Is FDA regulated |
No |
Health authority |
|
Study type |
Observational
|
Clinical Trial Summary
The objective of this study is to evaluate the change of endothelial cell count after XEN45
in patients with or without cataract operation.
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)