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This is a prospective, single-center, single-arm, open-label, clinical study of the investigational TECNIS Symfony® Toric IOL. The study will enroll up to 100 subjects from a single investigative site in China. The subjects will be followed for 12-months postoperatively.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| TECNIS Symfony Toric IOL | Experimental | Model Series ZXT |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Model Series ZXT | Device | Investigational intraocular lens replaces the natural lens removed during cataract surgery in both eyes. |
|
| Measure | Description | Time Frame |
|---|---|---|
| percentage of eyes that are measured at the 1-week postoperative visit to demonstrate ≤10º change from the intended IOL axis at the end of surgery | 1 week |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Johnson & Johnson Surgical Vision Clinical Trials | Johnson & Johnson Surgical Vision | Study Director |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| The Second Affiliated Hospital Zhejiang University School of Medicine | Hangzhou | 310009 | China |
Johnson & Johnson Medical Devices Companies have an agreement with the Yale Open Data Access (YODA) Project to serve as the independent review panel for evaluation of requests for clinical study reports and participant level data from investigators and physicians for scientific research that will advance medical knowledge and public health. Requests for access to the study data can be submitted through the YODA project site at http://yoda.yale.edu
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| ID | Term |
|---|---|
| D002386 | Cataract |
| ID | Term |
|---|---|
| D007905 | Lens Diseases |
| D005128 | Eye Diseases |
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