NCT01878838

The Comparison of Cataract Lasers Using the Optimedica Catalys Laser and the Alcon LenSx Laser.

A Prospective Randomized Controlled Clinical Trial Comparing the Intra-operative Effects, Safety, Efficacy and Performance of Two Commercially Available Laser Systems in Patients Undergoing Femtosecond Laser-Assisted Cataract Surgery.

• Status: Completed
• Phase: N/A
• Study type: Interventional
• Enrollment: 45 (actual)
• Sponsor: Steven H. Linn, OD · Academic / Other
• Sex: All
• Age: 22 Years
• Healthy volunteers: Not accepted

Summary

This study compares two FDA approved Cataract Lasers.

Detailed description

The purpose of this study is to systematically evaluate the performance of two commercially available and FDA cleared femtosecond laser systems in patients undergoing femtosecond laser-assisted cataract surgery. Objective data on the repeatability and accuracy of the studied parameters will be gathered and reported as endpoints of the study. The two systems studied are the Catalys™ Precision Laser System (OptiMedica, CA, USA) and the LenSx® Laser System (Alcon Laboratories, Inc., Fort Worth, TX). Published data have suggested that the femtosecond laser is a useful tool for cataract surgery. This study is to determine whether differences or similarities exist in specific treatment parameters achieved with two FDA cleared and commercially available femtosecond laser cataract surgery platforms

Conditions

• Nuclear Sclerosis of the Lens
• Posterior Subcapsular Cataract
• Cortical Cataract

Interventions

Type	Name	Description
PROCEDURE	Femtosecond Laser Assisted Cataract Surgery w/ Catalys Laser	Cohort subjects will undergo Femtosecond Laser Assisted Cataract Surgery in both eyes, with the Optimedica Catalys laser on one eye, and the Alcon LensX laser on the other. First eyes will be randomized.
PROCEDURE	Femtosecond Laser Assisted Cataract Surgery w/ LenSx Laser	Cohort subjects will undergo Femtosecond Laser Assisted Cataract Surgery in both eyes, with the Optimedica Catalys laser on one eye, and the Alcon LensX laser on the other. First eyes will be randomized.

Timeline

• Start date: 2013-04-01
• Primary completion: 2013-12-01
• Completion: 2014-01-01
• First posted: 2013-06-17
• Last updated: 2025-03-11

Locations

1 site across 1 country: United States