EX-PRESS® P-50 and EX-PRESS® P-200
Study Details
Study Description
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.
| Condition or Disease | Intervention/Treatment | Phase |
|---|---|---|
|
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
Arms and Interventions
| Arm | Intervention/Treatment |
|---|---|
| EX-PRESS P-50 EX-PRESS P-50 filtration device implanted in one or both eyes during glaucoma surgery |
Device: EX-PRESS P-50 filtration device
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 EX-PRESS P-200 filtration device implanted in one or both eyes during glaucoma surgery |
Device: EX-PRESS P-200 filtration device
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
|
Outcome Measures
Primary Outcome Measures
- Percentage reduction in intraocular pressure (IOP) from baseline [Baseline (preoperative), up to Year 5 postoperative]
IOP will be measured for each eye individually using applanation tonometry and recorded in millimeters mercury (mmHG).
Eligibility Criteria
Criteria
Key Inclusion Criteria:
-
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;
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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:
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Enrolled in any clinical trial within the last 5 years;
-
At the time of implantation:
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Presence of ocular disease such as uveitis, ocular infection, severe dry eye, severe blepharitis.
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Pre-existing ocular or systemic pathology that, in the opinion of the surgeon, is likely to cause postoperative complications following implantation of the device.
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Diagnosed with angle-closure glaucoma.
- Other protocol-defined exclusion criteria may apply.
Contacts and Locations
Locations
No locations specified.Sponsors and Collaborators
- Alcon Research
Investigators
- Study Director: Clinical Trial Lead, Vision Care, Alcon Research, LLC
Study Documents (Full-Text)
None provided.More Information
Publications
None provided.- GLR516-P001