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FDA approval received for product, no additional study subjects required.
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The objective of this study is to evaluate the safety and efficacy the OptiMedica Femtosecond Laser System, also known as the Catalys™ Precision Laser System, to perform two surgical maneuvers used in the treatment of subjects with cataracts. Efficacy will be evaluated by comparisons to the standard surgical procedure of continuous curvilinear capsulorhexis (CCC) and ultrasonic phacoemulsification.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| U/S Surgery and CCC | Active Comparator | Ultrasound (U/S) cataract surgery and continuous curvilinear capsulorhexis (CCC). |
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| FS Laser Surgery | Experimental | For femtosecond laser-assisted cataract surgery (FS Laser Surgery), subjects will receive capsulotomy, lens segmentation and, at investigator discretion, lens softening using the femtosecond laser device. |
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| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| U/S Surgery and CCC | Procedure | Subjects will receive the standard of care for U/S cataract surgery and CCC to facilitate removal of the crystalline lens. |
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| Measure | Description | Time Frame |
|---|---|---|
| Capsulotomy Dimension | Capsulotomy size will be measured during surgery for both the experimental and control groups. | Day of Surgery |
| Measure | Description | Time Frame |
|---|---|---|
| Cumulative Dissipated Energy (CDE) | CDE (the amount of ultrasound energy delivered during phacoemulsification of the crystalline lens) used will be measured during surgery. | Day of Surgery |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Juan F. Batlle, MD | Laser Center | Principal Investigator |
| William W. Culbertson, MD | Bascom Palmer Eye Institute | Study Director |
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| ID | Term |
|---|---|
| D002386 | Cataract |
| ID | Term |
|---|---|
| D007905 | Lens Diseases |
| D005128 | Eye Diseases |
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| ID | Term |
|---|---|
| D059039 | Standard of Care |
| ID | Term |
|---|---|
| D019984 | Quality Indicators, Health Care |
| D011787 | Quality of Health Care |
| D006298 | Health Services Administration |
| D017530 | Health Care Quality, Access, and Evaluation |
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| FS Laser Surgery | Device | The Catalys System is an ophthalmic surgical laser system intended for use in cataract surgery. |
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