Approval Probability 71%
TA Base Rate26%
Adjusted LOA41%
ML RiskLOW_RISK
| NCT ID | Title | Phase | Status | Enrollment | Velocity | Design | Start | Completion | Last Updated | Sites | Countries |
|---|---|---|---|---|---|---|---|---|---|---|---|
| NCT01069172 | Study of the Femtosecond Laser System as Compared to Continuous Curvilinear Capsulorhexis for Cataract Surgery | PHASE3 | COMPLETED | 30 | — | — | Feb 1, 2010 | Aug 1, 2010 | Sep 4, 2014 | 1 | Dominican Republic |
Capsulotomy diameter measured during surgery for both the experimental and control groups.
| Arm | Type | Description |
|---|---|---|
| FS Laser Surgery | EXPERIMENTAL | For femtosecond laser-assisted cataract surgery group (FS Laser Surgery), subjects will receive capsulotomy, lens segmentation and, at investigator discretion, lens softening using the femtosecond laser device. If necessary, ultrasound (U/S) phacoemulsification will also be applied to facilitate removal of the crystalline lens during cataract surgery. |
| CCC Surgery | ACTIVE_COMPARATOR | For the continuous curvilinear capsulorhexis (CCC) group (CCC Surgery), subjects will receive the standard of care for CCC and U/S phacoemulsification surgery to facilitate removal of the crystalline lens during cataract surgery. |
| Name | Type | Description |
|---|---|---|
| FS Laser Surgery | DEVICE | The Catalys System is an ophthalmic surgical laser system intended for use in cataract surgery to perform capsulotomy, lens segmentation, and lens softening, which are all part of cataract surgery when this femtosecond laser is used. |
| CCC Surgery | PROCEDURE | Subjects will receive the standard of care for CCC and U/S cataract surgery to facilitate removal of the crystalline lens. CCC is a procedure that is part of cataract surgery. |
Inclusion Criteria: * Able and willing to comply with the treatment/follow-up schedule and requirements * Able to understand and provide written Informed Consent * ETDRS (Early Treatment of Diabetic Retinopathy Study) visual acuity equal to or worse than 20/32 (best corrected) * Age between 50 and ...