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This is a prospective and retrospective, single-center, single-arm, open-label clinical study of the TECNIS Eyhanceâ„¢ IOL. The study will enroll up to 100 subjects from a single site in China. All subjects will be followed for 12 months postoperatively.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| TECNIS Eyhance IOL | Experimental | Model ICB00 |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Model ICB00 | Device | Investigational intraocular lens replaces the natural lens removed during cataract surgery in one or both eyes. |
|
| Measure | Description | Time Frame |
|---|---|---|
| mean monocular postoperative DCIVA | 6 months | |
| percentage of eyes that achieve 0.3 ,0.2, 0.1 and 0.0 logMAR monocular DCIVA | 6 months |
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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 |
|---|---|---|---|---|---|---|
| Hainan Eye Optometry Eye Hospital Co., Ltd. No. 6 | Qionghai | Hainan | 571434 | 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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