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This is a prospective, open-label clinical study designed to evaluate the performance and safety of the JASPERâ„¢ Robotic Surgical System during cataract surgery.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| JASPERâ„¢ Robotic Surgical System | Experimental | Subjects will undergo cataract surgery using the JASPERâ„¢ Robotic Surgical System. |
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| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| JASPERâ„¢ Robotic Surgical System | Device | The JASPERâ„¢ Robotic Surgical System is a robotically assisted surgical system intended to assist ophthalmic surgeons in performing cataract surgery. |
| Measure | Description | Time Frame |
|---|---|---|
| Successful completion of planned Robotic-Assisted cataract surgery | Proportion of study eyes in which the planned robotic cataract surgery is completed using the JASPERâ„¢ Robotic Surgical System without conversion to manual technique. | Intra-operative |
| Measure | Description | Time Frame |
|---|---|---|
| Incidence and Type of Adverse Events (AEs) and Serious Adverse Events (SAEs) | Incidence and type of all AEs and SAEs occurring intraoperatively and during the postoperative follow-up period. | From surgery through 30 days post-procedure |
| Distribution of pre and postoperative Best Corrected Visual acuity |
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Main Inclusion Criteria:
Main Exclusion Criteria:
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| Name | Role | Phone | Extension | |
|---|---|---|---|---|
| Merav Gat, M.Sc., MBA | Contact | +972547800259 | merav.gat@forsightrobotics.com |
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| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Asian Eye Instiitute | Recruiting | Makati City | National Capital Region | 1200 | Philippines |
Individual participant data (IPD) will not be shared at this time due to privacy, confidentiality, and regulatory considerations. Future sharing may be considered under appropriate agreements and conditions.
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| ID | Term |
|---|---|
| D002386 | Cataract |
| ID | Term |
|---|---|
| D007905 | Lens Diseases |
| D005128 | Eye Diseases |
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Distribution of preoperative and postoperative BCVA |
| Baseline and up to 30 days post-procedure |
| Postoperative Ophthalmic examination findings | Postoperative slit lamp and dilated fundus examinations findings | Up to 30 days post-procedure |