Ignite Creation Date:
2024-05-06 @ 3:10 PM
Last Modification Date:
2024-10-26 @ 1:44 PM
Study NCT ID:
NCT04547036
Status:
COMPLETED
Last Update Posted:
2021-07-13
First Post:
2020-09-08
Brief Title:
Changes in Corneal Endothelial Cell Density After Transscleral ab Interno Glaucoma Gel Stent Implantation
Sponsor:
Paracelsus Medical University
Organization:
Paracelsus Medical University
Study Overview
Official Title:
Changes in Corneal Endothelial Cell Density After Transscleral ab Interno Glaucoma Gel Stent Implantation
Status:
COMPLETED
Status Verified Date:
2021-07
Last Known Status:
None
Delayed Posting:
No
If Stopped, Why?:
Not Stopped
Has Expanded Access:
False
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
None
Brief 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 -115 after Ahmed glaucoma valves and -124 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 SalzburgSALK
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
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 SalzburgSALK
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
Study Oversight
Has Oversight DMC:
None
Is a FDA Regulated Drug?:
False
Is a FDA Regulated Device?:
True
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
False
Is an FDA AA801 Violation?:
None