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To evaluate the ability of the TRUEVISION 3D VISUALIZATION AND GUIDANCE SYSTEM FOR MICROSURGERY to provide the ophthalmic surgeon appropriate alignment, orientation and sizing information during cataract or refractive lens exchange surgery. Device images, safety results and surgeon questionnaire will demonstrate that the TrueVision system provides clear images to assist surgeons during LRI or capsulorhexis procedures.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| LRI Templates | Active Comparator | To evaluate the ability of the TRUEVISION 3D VISUALIZATION AND GUIDANCE SYSTEM FOR MICROSURGERY to provide the ophthalmic surgeon appropriate alignment, orientation and sizing information during cataract or refractive lens exchange surgery compared to the current standard of care (manual markings or heuristic techniques) for LRI. |
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| Capsulorhexis Templates | Active Comparator | To evaluate the ability of the TRUEVISION 3D VISUALIZATION AND GUIDANCE SYSTEM FOR MICROSURGERY to provide the ophthalmic surgeon appropriate alignment, orientation and sizing information during cataract or refractive lens exchange surgery compared to the current standard of care (manual markings or heuristic techniques) for Capsulorhexis. |
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| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| TrueVision 3D Visualization and Guidance System for MicroSurgery | Device | Adjunct imaging tool (to the microscope oculars) that provides onscreen video guidance for alignment, orientation, and sizing during eye surgery, based on a surgeon's defined nomogram |
| Measure | Description | Time Frame |
|---|---|---|
| Demonstrate that the TrueVision system provides clear images to assist during LRI or capsulorhexis procedures | one month |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Mark Packer, MD | Oregon Eye Associates | Study Director |
| Robert Weinstock, MD | Eye Institute of West Florida | Principal Investigator |
| Jason Stahl, MD | Durrie Vision | Principal Investigator |
| Douglas Katsev, MD | Sansum Clinic | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Drs. Fine, Hoffman and Packer | Eugene | Oregon | 97401 | United States |
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| ID | Term |
|---|---|
| D008866 | Microsurgery |
| ID | Term |
|---|---|
| D013514 | Surgical Procedures, Operative |
| D008846 | Micromanipulation |
| D008919 | Investigative Techniques |
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