EX-PRESS® P-50 and EX-PRESS® P-200
1 other identifier
observational
122
1 country
2
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.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P50-P75 for all trials
Started Nov 2023
Shorter than P25 for all trials
2 active sites
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
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Study Timeline
Key milestones and dates
First Submitted
Initial submission to the registry
October 31, 2023
CompletedFirst Posted
Study publicly available on registry
November 7, 2023
CompletedStudy Start
First participant enrolled
November 21, 2023
CompletedPrimary Completion
Last participant's last visit for primary outcome
June 20, 2024
CompletedStudy Completion
Last participant's last visit for all outcomes
June 20, 2024
CompletedAugust 12, 2024
August 1, 2024
7 months
October 31, 2023
August 9, 2024
Conditions
Keywords
Outcome Measures
Primary Outcomes (1)
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).
Baseline (preoperative), up to Year 5 postoperative
Study Arms (2)
EX-PRESS P-50
EX-PRESS P-50 filtration device implanted in one or both eyes during glaucoma surgery
EX-PRESS P-200
EX-PRESS P-200 filtration device implanted in one or both eyes during glaucoma surgery
Interventions
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
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
Eligibility Criteria
Cohorts will be selected from approximately 12 investigative sites located in the United States and/or outside the United States, approximately 4 countries.
You may qualify if:
- 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;
You may not qualify if:
- 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.
Contact the study team to confirm eligibility.
Sponsors & Collaborators
- Alcon Researchlead
Study Sites (2)
Boozman Hoff Regional Eye Clinic
Rogers, Arkansas, 72756, United States
El Paso Eye Surgeons, PA
El Paso, Texas, 79922, United States
MeSH Terms
Conditions
Condition Hierarchy (Ancestors)
Study Officials
- STUDY DIRECTOR
Clinical Trial Lead, Vision Care
Alcon Research, LLC
Study Design
- Study Type
- observational
- Observational Model
- COHORT
- Time Perspective
- RETROSPECTIVE
- Sponsor Type
- INDUSTRY
- Responsible Party
- SPONSOR
Study Record Dates
First Submitted
October 31, 2023
First Posted
November 7, 2023
Study Start
November 21, 2023
Primary Completion
June 20, 2024
Study Completion
June 20, 2024
Last Updated
August 12, 2024
Record last verified: 2024-08
Data Sharing
- IPD Sharing
- Will not share