Status:
COMPLETED
EX-PRESS® P-50 and EX-PRESS® P-200
Lead Sponsor:
Alcon Research
Conditions:
Glaucoma
Eligibility:
All Genders
18+ years
Brief 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.
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...
Eligibility Criteria
Inclusion
- Key
- 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
- 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.
Key Trial Info
Start Date :
November 21 2023
Trial Type :
OBSERVATIONAL
Allocation :
ACTUAL
End Date :
June 20 2024
Estimated Enrollment :
122 Patients enrolled
Trial Details
Trial ID
NCT06119178
Start Date
November 21 2023
End Date
June 20 2024
Last Update
August 12 2024
Active Locations (2)
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1
Boozman Hoff Regional Eye Clinic
Rogers, Arkansas, United States, 72756
2
El Paso Eye Surgeons, PA
El Paso, Texas, United States, 79922