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The purpose of this clinical study is to evaluate the difference in depth of focus measured with two methods in patients implanted with either TECNIS 1-piece Monofocal IOL or TECNIS Eyhance IOL:
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Testing Order | The difference in diopters of depth of focus range achieving a threshold of 0.20 logMAR between Trial lens vs. Chart testing method per pre-study IOL group. |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| No intervention | Other | The difference in diopters of depth of focus range achieving a threshold of 0.20 logMAR between Trial lens vs. Chart testing method per pre-study IOL group. |
| Measure | Description | Time Frame |
|---|---|---|
| The difference in diopters of depth of focus range achieving a threshold of 0.20 logMAR between Trial lens vs. Chart testing method per pre-study IOL group. | The difference in diopters of depth of focus range achieving a threshold of 0.20 logMAR between Trial lens vs. Chart testing method per pre-study IOL group. | One day Visit study |
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Study Eye Inclusion Criteria:
Study Eye Exclusion Criteria
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As only one eye per subject will be enrolled in the study based on the eligibility criteria, up to 115 subjects will be enrolled to obtain data on approximately 80 subjects to account for approximately 30% screen failure rate.
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| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Empire Eye & Laser Center | Bakersfield | California | 93309 | United States | ||
| Jones Eye Center |
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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| Sioux City |
| Iowa |
| 51104 |
| United States |
| Cleveland Eye Clinic | Brecksville | Ohio | 44141 | United States |
| Parkhurst NuVision | San Antonio | Texas | 78229 | United States |