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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.
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.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| 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 |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| EX-PRESS P-50 filtration device | 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 |
| 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 |
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Key Inclusion Criteria:
Key Exclusion Criteria:
Enrolled in any clinical trial within the last 5 years;
At the time of implantation:
Other protocol-defined exclusion criteria may apply.
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Cohorts will be selected from approximately 12 investigative sites located in the United States and/or outside the United States, approximately 4 countries.
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| Name | Affiliation | Role |
|---|---|---|
| Clinical Trial Lead, Vision Care | Alcon Research, LLC | Study Director |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Boozman Hoff Regional Eye Clinic | Rogers | Arkansas | 72756 | United States | ||
| El Paso Eye Surgeons, PA |
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| ID | Term |
|---|---|
| D005901 | Glaucoma |
| ID | Term |
|---|---|
| D009798 | Ocular Hypertension |
| D005128 | Eye Diseases |
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| EX-PRESS P-200 filtration device | 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 |
|
| El Paso |
| Texas |
| 79922 |
| United States |