GlaucomaNCT06119178
EX-PRESS® P-50 and EX-PRESS® P-200
An observational study of Glaucoma, run by Alcon Research at 2 sites in United States.
Trial summary
The purpose of this Post-Market Clinical Follow-Up (PMCF) study is to assess long term clinical performance and safety outcomes for EX-PRESS Glaucoma Filtration Devices Models P-50 and P-200. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Glaucoma
- What is being tested?
- EX-PRESS P-50 filtration device and EX-PRESS P-200 filtration device
- Type of treatment
- Medical device
- How many people
- 122 participants
- Where
- 2 sitesUnited States
- Study dates
- 21 Nov 2023to 20 Jun 2024
- 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 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Study population: Cohorts will be selected from approximately 12 investigative sites located in the United States and/or outside the United States, approximately 4 countries.
Who may be able to join
- Able to understand and sign an Institutional Review Board (IRB) / Independent Ethics Committee (IEC) approved informed consent form authorizing data collection prior to the review of any medical records;
- Implanted (one eye or both) with the EXPRESS P-50 or EXPRESS P-200 device per indications for use for at least 5 years;
- Have a minimum of 5 years of recorded follow-up data;
- Other protocol-specified inclusion criteria may apply.
Who cannot join
- Enrolled in any clinical trial within the last 5 years;
- At the time of implantation:
- Presence of ocular disease such as uveitis, ocular infection, severe dry eye, severe blepharitis.
- Pre-existing ocular or systemic pathology that, in the opinion of the surgeon, is likely to cause postoperative complications following implantation of the device.
- Diagnosed with angle-closure glaucoma.
- Other protocol-defined exclusion criteria may apply.
Trial locations and contacts
2 sites in 1 country.
United States2 sites
El Paso Eye Surgeons, PA
El Paso, Texas, 79922
Boozman Hoff Regional Eye Clinic
Rogers, Arkansas, 72756
About this study
The purpose of this Post-Market Clinical Follow-Up (PMCF) study is to assess long term clinical performance and safety outcomes for EX-PRESS Glaucoma Filtration Devices Models P-50 and P-200.
Read the detailed description
This is a non-interventional/observational study designed as a retrospective chart review. Study sites will identify patient charts within their existing databases in a fair and consistent manner, e.g., reviewing all eligible charts in reverse chronological order by year of baseline visit. Patients meeting the eligibility criteria who have a minimum of 5 years of follow-up data since the implantation of the P-50 or P-200 device will be enrolled, including patients whose 5-year standard of care visit is scheduled during the study enrollment period.
The overall study duration is expected to be approximately 7 months.
- Conditions
- Glaucoma
- Being tested
- EX-PRESS P-50 filtration device, EX-PRESS P-200 filtration device
- Keywords
- Glaucoma
- Medical subject headings
- Glaucoma
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
EX-PRESS P-50 filtration deviceDevice
FDA-approved, stainless steel device with a 50-micron internal lumen size indicated for the reduction of intraocular pressure in glaucoma patients where medical and conventional surgical treatments have failed
EX-PRESS P-200 filtration deviceDevice
FDA-approved, stainless steel device with a 200-micron internal lumen size indicated for the reduction of intraocular pressure in glaucoma patients where medical and conventional surgical treatments have failed
| Study group | Role | What they receive |
|---|---|---|
| EX-PRESS P-50 | EX-PRESS P-50 filtration device implanted in one or both eyes during glaucoma surgery Receives: Device: EX-PRESS P-50 filtration device | |
| EX-PRESS P-200 | EX-PRESS P-200 filtration device implanted in one or both eyes during glaucoma surgery Receives: Device: EX-PRESS P-200 filtration device |
What is being measured
The primary outcome is the main question the study is designed to answer.
Percentage reduction in intraocular pressure (IOP) from baseline
IOP will be measured for each eye individually using applanation tonometry and recorded in millimeters mercury (mmHG).
Measured: Baseline (preoperative), up to Year 5 postoperative
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted7 Nov 2023
- Study start21 Nov 2023
- Primary completion20 Jun 2024
- Study completion20 Jun 2024
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for GlaucomaStudies of the same condition, open and under way.
- More trials run by Alcon ResearchThe sponsor's other registered studies.
- 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
- Retrospective
- Enrolment
- 122 participants (actual)
Sponsor and investigators
- Lead sponsor
- Alcon Research
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
- Investigators
- Clinical Trial Lead, Vision Care, Study director, Alcon Research, LLC
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06119178
- Sponsor's protocol ID
- GLR516-P001
- Status last verified
- Aug 2024
- First submitted
- 31 Oct 2023
- Last updated
- 12 Aug 2024
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 12 Aug 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- EX-PRESS® P-50 and EX-PRESS® P-200
- ClinicalTrials.gov ID
- NCT06119178
- Acronym / sponsor ID
- GLR516-P001
- Conditions
- Glaucoma
- Keywords
- Glaucoma
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 122 participants (actual)
- Lead sponsor
- Alcon ResearchIndustry (pharma, biotech, devices)
- Study start
- 21 Nov 2023 (actual)
- Primary completion
- 20 Jun 2024 (actual)
- Study completion
- 20 Jun 2024 (actual)
- First posted
- 7 Nov 2023 (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 Post-Market Clinical Follow-Up (PMCF) study is to assess long term clinical performance and safety outcomes for EX-PRESS Glaucoma Filtration Devices Models P-50 and P-200.
Detailed description
This is a non-interventional/observational study designed as a retrospective chart review. Study sites will identify patient charts within their existing databases in a fair and consistent manner, e.g., reviewing all eligible charts in reverse chronological order by year of baseline visit. Patients meeting the eligibility criteria who have a minimum of 5 years of follow-up data since the implantation of the P-50 or P-200 device will be enrolled, including patients whose 5-year standard of care visit is scheduled during the study enrollment period.
The overall study duration is expected to be approximately 7 months.
Study design
- Observational model
- Cohort
- Time perspective
- Retrospective
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| EX-PRESS P-50 | – | Device: EX-PRESS P-50 filtration deviceEX-PRESS P-50 filtration device implanted in one or both eyes during glaucoma surgery |
| EX-PRESS P-200 | – | Device: EX-PRESS P-200 filtration deviceEX-PRESS P-200 filtration device implanted in one or both eyes during glaucoma surgery |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study population
- Cohorts will be selected from approximately 12 investigative sites located in the United States and/or outside the United States, approximately 4 countries.
Key inclusion criteria (4 listed)
- Able to understand and sign an Institutional Review Board (IRB) / Independent Ethics Committee (IEC) approved informed consent form authorizing data collection prior to the review of any medical records;
- Implanted (one eye or both) with the EXPRESS P-50 or EXPRESS P-200 device per indications for use for at least 5 years;
- Have a minimum of 5 years of recorded follow-up data;
- Other protocol-specified inclusion criteria may apply.
Key exclusion criteria (6 listed)
- Enrolled in any clinical trial within the last 5 years;
- At the time of implantation:
- Other protocol-defined exclusion criteria may apply.
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 |
|---|---|---|
| EX-PRESS P-50 filtration deviceFDA-approved, stainless steel device with a 50-micron internal lumen size indicated for the reduction of intraocular pressure in glaucoma patients where medical and conventional surgical treatments have failed | Device | EX-PRESS P-50 |
| EX-PRESS P-200 filtration deviceFDA-approved, stainless steel device with a 200-micron internal lumen size indicated for the reduction of intraocular pressure in glaucoma patients where medical and conventional surgical treatments have failed | Device | EX-PRESS P-200 |
Primary outcome
Percentage reduction in intraocular pressure (IOP) from baseline
Time frame: Baseline (preoperative), up to Year 5 postoperative
IOP will be measured for each eye individually using applanation tonometry and recorded in millimeters mercury (mmHG).
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 12 Aug 2024.
- Individual participant dataSharing planned: No
Related trials for Glaucoma
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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.
Clinical Trial Lead, Vision Care study director
Alcon Research, LLC
2 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Glaucoma, run by Alcon Research at 2 sites 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 4 inclusion and 6 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 12 Aug 2024. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 2 sites 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 is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
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?
Percentage reduction in intraocular pressure (IOP) from baseline (time frame: Baseline (preoperative), up to Year 5 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 12 Aug 2024.