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Retrospective collection of data from medical records, multicenter, post-market clinical follow-up study.
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| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Intervention | Device | No study treatments will be administered during this retrospective study. However, data will be collected from medical records of patients who have been treated with subject devices of this study. |
| Measure | Description | Time Frame |
|---|---|---|
| Incidence of Adverse Events | incidence of adverse events that are specified in the ISO 11979-7 Safety and Performance Endpoints. | up to 12 months post-operation |
| BCDVA | The proportion of eyes achieving 20/40 or better BCDVA. | up to 12 months post-operation |
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Inclusion Criteria:
Exclusion Criteria:
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Patients who have been implanted with and/or have undergone ophthalmic surgery using commercial JJSV product(s).
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| Name | Affiliation | Role |
|---|---|---|
| Johnson & Johnson Surgical Vision, Inc. Clinical Trial | Johnson & Johnson Surgical Vision, Inc. | Study Director |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Trinity Research Group, LLC | Dothan | Alabama | 36301 | United States | ||
| Empire Eye and Laser Center |
Johnson & Johnson Medical Device Companies have an agreement with the Yale Open Data Access (YODA) 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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| Bakersfield |
| California |
| 93309 |
| United States |
| Chu Vision Institute | Bloomington | Minnesota | 55420 | United States |
| Valley Retina Institute | McAllen | Texas | 78503 | United States |
| Augenaerzte Gerl & Kollegen MVZ Ahaus GmbH | Ahaus | North Rhine-Westphalia | 48683 | Germany |
| Augenzentrum Erzgebirge | Zschopau | Saxony | 09405 | Germany |
| Augentagesklinik Spreebogen Berlin GbR | Berlin | 10559 | Germany |
| Clinica Vistahermosa | Alicante | Alacant | 03015 | Spain |
| Hospital La Arruzafa | Córdoba | Andalusia | 14012 | Spain |
| Instituto Universitario de Oftalmobiologia Aplicada | Valladolid | CL | 47011 | Spain |
| Hosp. De La Santa Creu I Sant Pau | Barcelona | CT | 08025 | Spain |
| Hospital Clinico San Carlos | Madrid | MD | 28040 | Spain |
| Clinica Oftalvist | Madrid | 28008 | Spain |
| ID | Term |
|---|---|
| D012030 | Refractive Errors |
| D005901 | Glaucoma |
| D002386 | Cataract |
| ID | Term |
|---|---|
| D005128 | Eye Diseases |
| D009798 | Ocular Hypertension |
| D007905 | Lens Diseases |
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| ID | Term |
|---|---|
| D008722 | Methods |
| ID | Term |
|---|---|
| D008919 | Investigative Techniques |
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