GlaucomaNCT03151577
Longitudinal Study on Glaucoma Surgery Using XEN® Gel Stent
A study testing XEN® Gel Stent implantation in people with Glaucoma and Glaucoma, Open-Angle, run by Swiss Vision Network.
Trial summary
To evaluate the safety and efficacy of the XEN® Gel Stent in mild to moderate glaucoma patients undergoing glaucoma surgery. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Glaucoma, Glaucoma, Open-Angle, Glaucoma, Angle-Closure
- What is being tested?
- XEN® Gel Stent implantation
- Type of treatment
- Surgery or procedure
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 150 participants
- Where
- No sites listed yet
- Study dates
- 1 Jan 2015to 31 May 2023
- Phase
- Interventional
- Are there results?
- None posted in the registry
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
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Mild to moderate glaucoma patients
- Have given written informed consent
- Aged 18 years or older of either sex
Who cannot join
- Patients not able to understand the character of the study
- Participation in other clinical research within the last 4 weeks
- Patients with end-stage glaucoma
- Patients with glaucoma surgery done before
About this study
To evaluate the safety and efficacy of the XEN® Gel Stent in mild to moderate glaucoma patients undergoing glaucoma surgery.
Read the detailed description
To evaluate the safety and efficacy of the XEN® Gel Stent in mild to moderate glaucoma patients undergoing glaucoma surgery.
Follow-up period is 2 years.
- Being tested
- XEN® Gel Stent implantation
- Medical subject headings
- Glaucoma, Glaucoma, Open-Angle, Glaucoma, Angle-Closure
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
XEN® Gel Stent implantationProcedure or surgery
Also called XEN® Gel Stent, Aquesys
Minimally invasive glaucoma surgery (MIGS) which consists of implanting a XEN® Gel Stent in the irido-corneal angle of the eye to drain the aqueous humour in the sub-conjunctival space to lower the IOP.
| Study group | Role | What they receive |
|---|---|---|
| Evolution of IOP after XEN® Gel Stent implantation | Other | To study the efficacy of the XEN® Gel Stent in lowering the IOP. Receives: Procedure: XEN® Gel Stent implantation |
What is being measured
The primary outcome is the main question the study is designed to answer.
Intraocular pressure
Change in IOP before and after XEN® Gel Stent implantation
Measured: Day 0 (=Baseline=before surgery), after surgery on day 1, day 3, week 1, month 1, month 3, month 6, year 1, year 2
Secondary outcomes (2)
Number of needlings
Number of needlings performed during the follow-up after surgery
Measured: 2 years
Number of antiglaucomatous medications
Change in number of antiglaucomatous medications before and after the surgery.
Measured: Day 0 (=Baseline=before surgery), after surgery on day 1, day 3, week 1, month 1, month 3, month 6, year 1, year 2
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted12 May 2017
- Study start1 Jan 2015
- Primary completion31 Jan 2019
- Study completion31 May 2023 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (2)Papers the sponsor has linked to this study.
- 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
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Model description
- Intraocular pressure, adverse events, complications, number of medications in mild to moderate glaucoma patients who underwent XEN® Gel Stent implantation were recorded. Data were collected in a 2 years follow-up.
- Masking
- None (open label)
- Enrolment
- 150 participants (actual)
Sponsor and investigators
- Lead sponsor
- Swiss Vision Network
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Dr. Kaweh Mansouri, Swiss Vision Network
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03151577
- Sponsor's protocol ID
- 2016-02077
- Other IDs
- 2016
- Status last verified
- May 2022
- First submitted
- 28 Apr 2017
- Last updated
- 5 May 2022
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Publications
Gillmann K, Bravetti GE, Rao HL, Mermoud A, Mansouri K. Bilateral XEN Stent Implantation: A Long-term Prospective Study of the Difference in Outcomes Between First-operated and Fellow Eyes. J Glaucoma. 2020 Jul;29(7):536-541. doi: 10.1097/IJG.0000000000001520.
PubMed 32341321Mansouri K, Gillmann K, Rao HL, Guidotti J, Mermoud A. Prospective Evaluation of XEN Gel Implant in Eyes With Pseudoexfoliative Glaucoma. J Glaucoma. 2018 Oct;27(10):869-873. doi: 10.1097/IJG.0000000000001045.
PubMed 30095603
Study at a glance
From the registry record, last updated by the sponsor on 5 May 2022. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Longitudinal Study on Glaucoma Surgery Using XEN® Gel Stent
- ClinicalTrials.gov ID
- NCT03151577
- Acronym / sponsor ID
- 2016-02077
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 150 participants (actual)
- Lead sponsor
- Swiss Vision NetworkUniversity, hospital or other
- Study start
- 1 Jan 2015 (actual)
- Primary completion
- 31 Jan 2019 (actual)
- Study completion
- 31 May 2023 (estimated)
- First posted
- 12 May 2017 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
To evaluate the safety and efficacy of the XEN® Gel Stent in mild to moderate glaucoma patients undergoing glaucoma surgery.
Detailed description
To evaluate the safety and efficacy of the XEN® Gel Stent in mild to moderate glaucoma patients undergoing glaucoma surgery.
Follow-up period is 2 years.
Study design
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
- Model description
- Intraocular pressure, adverse events, complications, number of medications in mild to moderate glaucoma patients who underwent XEN® Gel Stent implantation were recorded. Data were collected in a 2 years follow-up.
| Arm | Type | Receives |
|---|---|---|
| Evolution of IOP after XEN® Gel Stent implantation | Other | Procedure: XEN® Gel Stent implantationTo study the efficacy of the XEN® Gel Stent in lowering the IOP. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (3 listed)
- Mild to moderate glaucoma patients
- Have given written informed consent
- Aged 18 years or older of either sex
Key exclusion criteria (4 listed)
- Patients not able to understand the character of the study
- Participation in other clinical research within the last 4 weeks
- Patients with end-stage glaucoma
- Patients with glaucoma surgery done before
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 |
|---|---|---|
| XEN® Gel Stent implantationAlso: XEN® Gel Stent, AquesysMinimally invasive glaucoma surgery (MIGS) which consists of implanting a XEN® Gel Stent in the irido-corneal angle of the eye to drain the aqueous humour in the sub-conjunctival space to lower the IOP. | Procedure or surgery | Evolution of IOP after XEN® Gel Stent implantation |
Primary outcome
Intraocular pressure
Time frame: Day 0 (=Baseline=before surgery), after surgery on day 1, day 3, week 1, month 1, month 3, month 6, year 1, year 2
Change in IOP before and after XEN® Gel Stent implantation
2 secondary outcomes
Number of needlings
Time frame: 2 years
Number of antiglaucomatous medications
Time frame: Day 0 (=Baseline=before surgery), after surgery on day 1, day 3, week 1, month 1, month 3, month 6, year 1, year 2
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 5 May 2022.
- Derived from this study: PubMed 32341321Gillmann K, Bravetti GE, Rao HL, Mermoud A, Mansouri K. Bilateral XEN Stent Implantation: A Long-term Prospective Study of the Difference in Outcomes Between First-operated and Fellow Eyes. J Glaucoma. 2020 Jul;29(7):536-541. doi: 10.1097/IJG.0000000000001520.
- Derived from this study: PubMed 30095603Mansouri K, Gillmann K, Rao HL, Guidotti J, Mermoud A. Prospective Evaluation of XEN Gel Implant in Eyes With Pseudoexfoliative Glaucoma. J Glaucoma. 2018 Oct;27(10):869-873. doi: 10.1097/IJG.0000000000001045.
- Individual participant dataSharing planned: No
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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.
Questions about this trial
What is this clinical trial studying?
A study testing XEN® Gel Stent implantation in people with Glaucoma and Glaucoma, Open-Angle, run by Swiss Vision Network.
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 3 inclusion and 4 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: status not confirmed, as of the sponsor's last update on 5 May 2022. Status can change between updates, so confirm with the study contact before making plans.
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?
Results are not available in the source record.
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?
Intraocular pressure (time frame: Day 0 (=Baseline=before surgery), after surgery on day 1, day 3, week 1, month 1, month 3, month 6, year 1, year 2). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT03151577, which also lists 2 linked publications.
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 5 May 2022.