GlaucomaNCT04547036
Changes in Corneal Endothelial Cell Density After Transscleral ab Interno Glaucoma Gel Stent Implantation
An observational study of Glaucoma and Endothelial Cell Loss, Corneal, run by Paracelsus Medical University at 1 site in Austria.
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. Read more about this study
- Who is it for?
- Ages 18 years and olderHealthy volunteers can take part
- Conditions the study is for
- Glaucoma, Endothelial Cell Loss, Corneal
- What is being tested?
- XEN45
- Type of treatment
- Medical device
- How many people
- 129 participants
- Where
- 1 siteAustria
- Study dates
- 30 Jan 2020to 30 Apr 2021
- Phase
- Observational
- Are there results?
- Yes, posted in the registrySummary in the doctors' view
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- Healthy volunteers accepted
- Adult, Older adult
Study population: 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.
Who may be able to join
- 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
Who cannot join
- 1. 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.
Trial locations and contacts
1 site in 1 country.
Austria1 site
Dept. Ophthalmology and Optometry Paracelsus Medical University
Salzburg, 5020
About this study
The objective of this study is to evaluate the change of endothelial cell count after XEN45 in patients with or without cataract operation.
Read the 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:
- Endothelial cell count on different locations of the study eye
- Central corneal thickness
- Anterior segment optical coherence tomography (to determine the position of the XEN45)
- Slit lamp examination of the cornea, anterior segment including gonioscopy (to determine the position of the XEN45), and dilated fundus examination
- Best corrected visual acuity
- Measurement of IOP
- Number and frequency of ocular (glaucoma) medications
- Ocular symptoms and assessment of complications (especially symptoms, which may be a hint for loss of endothelial cell count)
- 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
- Being tested
- XEN45
- Medical subject headings
- Glaucoma, Corneal Endothelial Cell Loss
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
XEN45Device
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.
| Study group | Role | What they receive |
|---|---|---|
| Endothelial cell count measurment | Not described Receives: Device: XEN45 |
What is being measured
The primary outcome is the main question the study is designed to answer.
Endothelial Cell Count Change
The primary endpoint is the change of central endothelial cell density compared to preoperative data.
Measured: baseline compared to 1-5 years postoperative
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted14 Sep 2020
- Study start30 Jan 2020
- Primary completion31 Jan 2021
- Study completion30 Apr 2021
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Posted resultsParticipant flow, outcome measures and adverse events reported by the sponsor.
- Other trials for GlaucomaStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Cohort
- Time perspective
- Prospective
- Enrolment
- 129 participants (actual)
Sponsor and investigators
- Lead sponsor
- Paracelsus Medical University
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Prof. Dr. Herbert Reitsamer, Paracelsus Medical University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04547036
- Sponsor's protocol ID
- 0010152018
- Status last verified
- Jul 2021
- First submitted
- 8 Sep 2020
- Last updated
- 13 Jul 2021
- Results posted
- Yes, on ClinicalTrials.gov
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- Yes
- Individual data sharing
- Undecided
Study at a glance
From the registry record, last updated by the sponsor on 13 Jul 2021. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Changes in Corneal Endothelial Cell Density After Transscleral ab Interno Glaucoma Gel Stent Implantation
- ClinicalTrials.gov ID
- NCT04547036
- Acronym / sponsor ID
- 0010152018
- Conditions
- Glaucoma, Endothelial Cell Loss, Corneal
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 129 participants (actual)
- Lead sponsor
- Paracelsus Medical UniversityUniversity, hospital or other
- Study start
- 30 Jan 2020 (actual)
- Primary completion
- 31 Jan 2021 (actual)
- Study completion
- 30 Apr 2021 (actual)
- First posted
- 14 Sep 2020 (actual)
- Results
- Posted 13 Jul 2021
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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:
- Endothelial cell count on different locations of the study eye
- Central corneal thickness
- Anterior segment optical coherence tomography (to determine the position of the XEN45)
- Slit lamp examination of the cornea, anterior segment including gonioscopy (to determine the position of the XEN45), and dilated fundus examination
- Best corrected visual acuity
- Measurement of IOP
- Number and frequency of ocular (glaucoma) medications
- Ocular symptoms and assessment of complications (especially symptoms, which may be a hint for loss of endothelial cell count)
- Secondary surgical procedures (if applicable including needlings, lasers, cataract operation, bleb revisions, keratoplasty, secondary IOP lowering procedures, other operations)
Study design
- Observational model
- Cohort
- Time perspective
- Prospective
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Endothelial cell count measurment | – | Device: XEN45 |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
- Study population
- 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.
Key inclusion criteria (6 listed)
- 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
Key exclusion criteria (1 listed)
- 1. 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.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| XEN45Up 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. | Device | Endothelial cell count measurment |
Primary outcome
Endothelial Cell Count Change
Time frame: baseline compared to 1-5 years postoperative
The primary endpoint is the change of central endothelial cell density compared to preoperative data.
Results and safety
Loading the posted results from ClinicalTrials.gov…
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 13 Jul 2021.
- Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
- Individual participant dataSharing planned: Undecided
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
The record lists no contact. Use the official record to reach the sponsor.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Glaucoma and Endothelial Cell Loss, Corneal, run by Paracelsus Medical University at 1 site in Austria.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 6 inclusion and 1 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 13 Jul 2021. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Austria. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
Yes. Results are posted in the registry (first posted 13 Jul 2021). A summary is in the For doctors view, and the full results are on ClinicalTrials.gov.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Endothelial Cell Count Change (time frame: baseline compared to 1-5 years postoperative). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 13 Jul 2021.