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Sponsor decided not to pursue market release of prototype device used in this study
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The purpose of this study is to evaluate the feasibility of using the Femtosecond Laser System to perform surgical maneuvers during cataract extraction surgery.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| 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 OptiMedica Catalys™ Precision Laser System (Catalys System) |
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| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| FS Laser Surgery | Procedure | The Catalys System is an ophthalmic surgical laser system intended for use in cataract surgery. The intervention consists of the both surgery and the use of the device. |
| Measure | Description | Time Frame |
|---|---|---|
| Capsulotomy Size | Capsulotomy size will be measured during surgery. | Day of Surgery |
| Measure | Description | Time Frame |
|---|---|---|
| Cumulated 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, Santo Domingo, Dominican Republic | Principal Investigator |
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| ID | Term |
|---|---|
| D002386 | Cataract |
| ID | Term |
|---|---|
| D007905 | Lens Diseases |
| D005128 | Eye Diseases |
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| FS Laser System | Device | The Catalys System is an ophthalmic surgical laser system intended for use in cataract surgery. The intervention consists of the both surgery and the use of the device. |
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