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A Study to Evaluate the enVista® Aspire (EA) intraocular lens in Subjects Undergoing Cataract Extraction
A Non-interventional, Prospective, Multicenter, Single Arm, Post-Marketing Clinical Study to Evaluate the enVista® Aspire (EA) Intraocular Lens in Subjects Undergoing Cataract Extraction
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| enVista Aspire intraocular lens (IOL) | Subjects bilaterally implanted with enVista Aspire EA IOLs. |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| enVista Aspire EA IOLs | Device | Subjects bilaterally implanted with enVista Aspire EA IOLs |
|
| Measure | Description | Time Frame |
|---|---|---|
| Mean binocular BCDVA (logMAR) at Visit 1 | Mean binocular best-corrected distance visual acuity (BCDVA) (logMAR) at Visit 1. Photopic BCDVA measured at 4 meters. | Day 60 to Day 270 after second eye implantation |
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Inclusion Criteria:
Exclusion Criteria:
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Patient population at study site locations
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| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| SITE 104 | Dover | New Jersey | 07801 | United States | ||
| Site 105 |
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| ID | Term |
|---|---|
| D002386 | Cataract |
| ID | Term |
|---|---|
| D007905 | Lens Diseases |
| D005128 | Eye Diseases |
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| Woodland Park |
| New Jersey |
| 07424 |
| United States |
| Site 103 | Garden City | New York | 11530 | United States |
| Site 107 | Cranberry Township | Pennsylvania | 16066 | United States |
| Site 106 | Charleston | South Carolina | 29407 | United States |
| Site 101 | Sugar Land | Texas | 77478 | United States |
| Site 102 | Mount Pleasant | Wisconsin | 53405 | United States |