Approval Probability
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FS Laser Surgery, CCC Surgery · 1 trial · 1 indication
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 ...
FS Laser Surgery, CCC Surgery is used for cataract treatment. It is an investigational procedure being studied in cataract surgery, comparing femtosecond laser technology with continuous curvilinear capsulorhexis. The therapy is in Phase 3 clinical development and has not been approved by regulatory authorities.
Abbott Laboratories (NYSE: ABT) is developing FS Laser Surgery, CCC Surgery. The company is conducting clinical research on this cataract treatment approach, which is currently in Phase 3 trials.
FS Laser Surgery, CCC Surgery is in Phase 3 clinical development. It is an investigational procedure for cataract treatment and has not been approved by regulatory authorities. One Phase 3 trial has been completed.
FS Laser Surgery, CCC Surgery has one completed Phase 3 trial, NCT01069172, titled 'Study of the Femtosecond Laser System as Compared to Continuous Curvilinear Capsulorhexis for Cataract Surgery.' The trial enrolled 30 participants aged 50 years and older in the Dominican Republic.
FS Laser Surgery refers to femtosecond laser technology used in cataract surgery. The clinical trial compares this laser system to continuous curvilinear capsulorhexis, a manual technique. The study evaluates the femtosecond laser's performance in creating the capsulorhexis opening during cataract procedures.