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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 the subject device of this study. |
| Measure | Description | Time Frame |
|---|---|---|
| Visual Acuity | Visual Acuity will be collected via observed case data in units of logMAR. | 1-month postoperative |
| Manifest Refraction | Manifest Refraction will be collected via observed case data in units of diopters. | 1-month postoperative |
| Visual Symptoms/Complaints | Visual Symptoms/Complaints will be measured using a questionnaire on a 5-point scale. | 1-month postoperative |
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Inclusion Criteria:
Exclusion Criteria:
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Pseudophakic patients previously bilaterally implanted with TECNIS Odyssey IOL.
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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 |
|---|---|---|---|---|---|---|
| Assil Eye Institute | Beverly Hills | California | 90210 | United States | ||
| The Eye Institute of West Florida |
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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| Largo |
| Florida |
| 33770 |
| United States |
| Center for Sight | Sarasota | Florida | 34239 | United States |
| Aloha Vision Consultants | Honolulu | Hawaii | 96816 | United States |
| OCLI Vision | Garden City | New York | 11530 | United States |
| Vance Thompson Vision | West Fargo | North Dakota | 58078 | United States |
| Cleveland Eye Clinic | Brecksville | Ohio | 44141 | United States |
| Carolina EyeCare Physicians | Mt. Pleasant | South Carolina | 29464 | United States |
| Loden Vision Centers | Goodlettsville | Tennessee | 37072 | United States |
| Dell Laser Consultants | Austin | Texas | 78746 | United States |
| Whitsett Vision Group | Houston | Texas | 77055 | United States |
| Virginia Eye Consultants | Norfolk | Virginia | 23502 | United States |
| ID | Term |
|---|---|
| D002386 | Cataract |
| ID | Term |
|---|---|
| D007905 | Lens Diseases |
| D005128 | Eye Diseases |
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| ID | Term |
|---|---|
| D008722 | Methods |
| ID | Term |
|---|---|
| D008919 | Investigative Techniques |
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