NCT06119178Completed
EX-PRESS® P-50 and EX-PRESS® P-200
Source: ClinicalTrials.gov · Last updated 12 Aug 2024
Brief summary (registry, in English)
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.
- Status (registry)
- Completed
- Study type
- Observational
- Enrollment
- 122 (actual)
- First submitted
- 31 Oct 2023
- Start date
- 21 Nov 2023
- Primary completion date
- 20 Jun 2024
- Lead sponsor
- Alcon Research
- Diseases
- Glaucoma
- NCT number
- NCT06119178
What you commit to
- Study type: Observational
- Participants enrolled: 122
- From 21 Nov 2023 to the primary completion date, 20 Jun 2024
- 2 sites in 1 country
- Visits and tests: ask the trial team, the registry does not list them
Built from the registry fields of ClinicalTrials.gov. It describes the study, not your situation.
Who cannot take part
Copied verbatim from ClinicalTrials.gov and grouped by topic. Only the trial team decides who can take part.
Other illness
- 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
- Enrolled in any clinical trial within the last 5 years;
- Other protocol-defined exclusion criteria may apply.
Who the study is looking for
- 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.
Age in the registry: 18 years to - · Sex: All · Does not accept healthy volunteers
Sites (2)
Sites in registry order. Pick your city on the disease page to sort them by distance.
| Site | City | Country | Site status |
|---|---|---|---|
| El Paso Eye Surgeons, PA Coordinator of this site? Confirm its status | El Paso | United States | Unknown status |
| Boozman Hoff Regional Eye Clinic Coordinator of this site? Confirm its status | Rogers | United States | Unknown status |
This page is information, not medical advice. Discuss any trial with your doctor.