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Evaluation of the safety and effectiveness of the ELIOS System procedure to reduce intraocular pressure (IOP) in adult subjects with mild to moderate primary open-angle glaucoma (POAG) undergoing cataract surgery
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| ELIOS Procedure | Other | ELIOS Procedure |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| ELIOS Procedure | Device | Treatment with the ELIOS System |
|
| Measure | Description | Time Frame |
|---|---|---|
| Proportion of subjects who achieve a decrease in medication-free mean diurnal IOP (DIOP) from baseline of at least 20% | Proportion of subjects who achieve a decrease in medication-free mean diurnal IOP (DIOP) from baseline of at least 20% | 24 Month |
| Measure | Description | Time Frame |
|---|---|---|
| Mean Change in medication-free DIOP from baseline | Mean change in medication-free DIOP from baseline | 24 Month |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Iqbal (Ike) Ahmed, MD | Prism Eye Institute | Study Director |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| ELIOS Vision Clinical Site | Glendale | Arizona | 85306 | United States | ||
| ELIOS Vision Clinical Site |
No IPD planned to be shared with other researchers
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| Petaluma |
| California |
| 94954 |
| United States |
| ELIOS Vision Clinical Site | Fort Collins | Colorado | 80528 | United States |
| ELIOS Vision Clinical Site | Grand Junction | Colorado | 81501 | United States |
| ELIOS Vision Clinical Site | DeLand | Florida | 32720 | United States |
| ELIOS Vision Clinical Site | Largo | Florida | 33770 | United States |
| ELIOS Vision Clinical Site | Melbourne | Florida | 32904 | United States |
| ELIOS Vision Clinical Site | Vero Beach | Florida | 32960 | United States |
| ELIOS Vision Clinical Site | Rock Island | Illinois | 61201 | United States |
| ELIOS Vision Clinical Site | Overland Park | Kansas | 66213 | United States |
| ELIOS Vision Clinical Site | Chaska | Minnesota | 55318 | United States |
| ELIOS Vision Clinical Site | St Louis | Missouri | 63131 | United States |
| ELIOS Vision Clinical Site | Las Vegas | Nevada | 89145 | United States |
| ELIOS Vision Clinical Site | South Orange | New Jersey | 07079 | United States |
| ELIOS Vision Clinical Site | Oklahoma City | Oklahoma | 73112 | United States |
| ELIOS Vision Clinical Site | Duncanville | Texas | 75137 | United States |
| ELIOS Vision Clinical Site | El Paso | Texas | 79902 | United States |
| Elios Vision Clinical Site 2 | San Antonio | Texas | 78229 | United States |
| ELIOS Vision Clinical Site | San Antonio | Texas | 78229 | United States |
| ELIOS Vision Clinical Site | Kenosha | Wisconsin | 53142 | United States |
| ID | Term |
|---|---|
| D005902 | Glaucoma, Open-Angle |
| ID | Term |
|---|---|
| D005901 | Glaucoma |
| D009798 | Ocular Hypertension |
| D005128 | Eye Diseases |
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