Primary Open Angle GlaucomaNCT04141865
Effect of Xen Implantation on the Aqueous Humor Proteome
An observational study of Primary Open Angle Glaucoma, run by Price Vision Group at 1 site in United States.
Trial summary
The purpose of this study is to determine how the aqueous humor proteome changes after implantation of a Xen microstent for treatment of glaucoma. Read more about this study
- Who is it for?
- Ages 18 to 90 years
- Conditions the study is for
- Primary Open Angle Glaucoma
- What is being tested?
- Xen and Aqueous shunt
- Type of treatment
- Medical device
- How many people
- 3 participants
- Where
- 1 siteUnited States
- Study dates
- 24 Oct 2019to 15 Feb 2022
- Phase
- Observational
- 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 to 90 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Study population: Patients with open angle glaucoma treated with a glaucoma drainage device.
Who may be able to join
- Male or female of any racial or ethnic origin, 18 years or older
- Able to provide written informed consent.
- Scheduled to undergo Xen implantation for open angle glaucoma or already has an aqueous shunt
Who cannot join
- History of conjunctivitis or any ocular infection within the past 3 weeks.
- Any active inflammation of the cornea or the anterior chamber (uveitis)
Trial locations and contacts
1 site in 1 country.
About this study
The purpose of this study is to determine how the aqueous humor proteome changes after implantation of a Xen microstent for treatment of glaucoma.
Read the detailed description
The purpose of this study is to determine how the aqueous humor proteome changes after implantation of a Xen microstent for treatment of glaucoma using liquid chromatography mass spectrometry.
- Conditions
- Primary Open Angle Glaucoma
- Being tested
- Xen, Aqueous shunt
- Medical subject headings
- Glaucoma, Open-Angle
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
XenDevice
Xen microstent implantation
Aqueous shuntDevice
Aqueous shunt implantation
| Study group | Role | What they receive |
|---|---|---|
| Xen | Patients treated with a Xen microstent for glaucoma. Receives: Device: Xen | |
| Aqueous shunt | Patients treated with an aqueous shunt for glaucoma. Receives: Device: Aqueous shunt |
What is being measured
The primary outcome is the main question the study is designed to answer.
Aqueous humor proteome
The aqueous humor proteome will be assessed with liquid chromotography/mass spectometry (quantitative LC-MS/MS).
Measured: Change from baseline at 6 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted28 Oct 2019
- Study start24 Oct 2019
- Primary completion15 Feb 2022
- Study completion15 Feb 2022
Why it stopped: low enrollment
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Primary Open Angle 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
- 3 participants (actual)
Sponsor and investigators
- Lead sponsor
- Price Vision Group
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
- Investigators
- Francis Price, Jr, MD, Principal investigator, Price Vision Group
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04141865
- Sponsor's protocol ID
- 2019-006
- Status last verified
- Feb 2022
- First submitted
- 24 Oct 2019
- Last updated
- 3 Mar 2022
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- Yes
- Individual data sharing
- No: de-identified data will be available upon request
Study at a glance
From the registry record, last updated by the sponsor on 3 Mar 2022. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Effect of Xen Implantation on the Aqueous Humor Proteome
- ClinicalTrials.gov ID
- NCT04141865
- Acronym / sponsor ID
- 2019-006
- Conditions
- Primary Open Angle Glaucoma
- Study type
- Observational
- Recruitment status
- TerminatedReason stopped: low enrollment
- Enrolment
- 3 participants (actual)
- Lead sponsor
- Price Vision GroupIndustry (pharma, biotech, devices)
- Study start
- 24 Oct 2019 (actual)
- Primary completion
- 15 Feb 2022 (actual)
- Study completion
- 15 Feb 2022 (actual)
- First posted
- 28 Oct 2019 (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.
The purpose of this study is to determine how the aqueous humor proteome changes after implantation of a Xen microstent for treatment of glaucoma.
Detailed description
The purpose of this study is to determine how the aqueous humor proteome changes after implantation of a Xen microstent for treatment of glaucoma using liquid chromatography mass spectrometry.
Study design
- Observational model
- Cohort
- Time perspective
- Prospective
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Xen | – | Device: XenPatients treated with a Xen microstent for glaucoma. |
| Aqueous shunt | – | Device: Aqueous shuntPatients treated with an aqueous shunt for glaucoma. |
Who may qualify
- Ages
- 18 to 90 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study population
- Patients with open angle glaucoma treated with a glaucoma drainage device.
Key inclusion criteria (3 listed)
- Male or female of any racial or ethnic origin, 18 years or older
- Able to provide written informed consent.
- Scheduled to undergo Xen implantation for open angle glaucoma or already has an aqueous shunt
Key exclusion criteria (2 listed)
- History of conjunctivitis or any ocular infection within the past 3 weeks.
- Any active inflammation of the cornea or the anterior chamber (uveitis)
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 |
|---|---|---|
| XenXen microstent implantation | Device | Xen |
| Aqueous shuntAqueous shunt implantation | Device | Aqueous shunt |
Primary outcome
Aqueous humor proteome
Time frame: Change from baseline at 6 months
The aqueous humor proteome will be assessed with liquid chromotography/mass spectometry (quantitative LC-MS/MS).
Results and safety
The study was stopped early (reason given: low enrollment). Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 3 Mar 2022.
- Individual participant dataSharing planned: No. de-identified data will be available upon request
Related trials for Primary Open Angle Glaucoma
RecruitingPhase 2
A Phase 2a Study Comparing the Efficacy, Safety and Tolerability of Pregabalin Eye Drops Comparing With Timolol Eye Drops in Adults With Glaucoma or High Eye Pressure.
Primary Open - Angle Glaucoma (POAG), Ocular Hypertension (OHT)
Recruiting
The Acute Effect of Exercise Type And Timing on Ambulatory Blood Pressure and Intra-Ocular Pressure in Individuals With Glaucoma (The ACHIEVE-project).
Glaucoma Open-Angle Primary, Hypertension
RecruitingObservational study
PRESERFLO™ MicroShunt XI Observational PMCF Study With no Control Group
Primary Open Angle Glaucoma
Active, not recruitingObservational study
Glaucoma, Visual Field Loss, and Their Association With Life Space in Older Adults
Primary Open Angle Glaucoma
Active, not recruitingObservational study
Impact of Glaucoma and Visual Field Loss on Life Space
Primary Open-angle Glaucoma
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.
Francis Price, Jr, MD principal investigator
Price Vision Group
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 Primary Open Angle Glaucoma, run by Price Vision Group at 1 site in United States.
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 2 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: stopped early, as of the sponsor's last update on 3 Mar 2022. 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 United States. 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?
The study was stopped early (reason given: low enrollment). 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?
Aqueous humor proteome (time frame: Change from baseline at 6 months). 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 3 Mar 2022.