EX-PRESS® P-50 and EX-PRESS® P-200

Study Overview
=================
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., 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.

Official Title
-----------------
EX-PRESS® P-50 and EX-PRESS® P-200

Conditions
-----------------
Glaucoma

Intervention / Treatment
-----------------
* Device: EX-PRESS P-50 filtration device
* Device: EX-PRESS P-200 filtration device


Participation Criteria
=================
Eligibility 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; 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: 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.

Ages Eligible for Study
-----------------
Minimum Age: 18 Years

Sexes Eligible for Study
-----------------
All

Accepts Healthy Volunteers
-----------------
No

Study Plan
=================
How is the study designed?
-----------------

Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| EX-PRESS P-50<br>EX-PRESS P-50 filtration device implanted in one or both eyes during glaucoma surgery | Device: EX-PRESS P-50 filtration device<br>* 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<br>|
| EX-PRESS P-200<br>EX-PRESS P-200 filtration device implanted in one or both eyes during glaucoma surgery | Device: EX-PRESS P-200 filtration device<br>* 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<br>|

What is the study measuring?
-----------------
Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| 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 | 

 Terms related to the study
=================
Keywords Provided by Centre Hospitalier Valida
-----------------
Glaucoma