NCT02110212

Femtosecond Laser for Cataract Surgery

A Prospective, Randomized Study of Cataract Surgery With the Assistance of the OptiMedica Femtosecond Laser System Compared to Standard Surgical Procedure of Continuous Curvilinear Capsulorhexis and Ultrasonic Phacoemulsification

• Status: Terminated
• Phase: Phase 3
• Study type: Interventional
• Enrollment: 17 (actual)
• Sponsor: Abbott Medical Optics · Industry
• Sex: All
• Age: 50 Years – 80 Years
• Healthy volunteers: Not accepted

Summary

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.

Conditions

• Cataract

Interventions

Type	Name	Description
PROCEDURE	U/S Surgery and CCC	Subjects will receive the standard of care for U/S cataract surgery and CCC to facilitate removal of the crystalline lens.
DEVICE	FS Laser Surgery	The Catalys System is an ophthalmic surgical laser system intended for use in cataract surgery.

Timeline

• Start date: 2011-04-01
• Primary completion: 2011-12-01
• Completion: 2014-02-01
• First posted: 2014-04-10
• Last updated: 2025-02-04