Clinical Trial: Study of the Femtosecond Laser System as Compared to Continuous Curvilinear Capsulorhexis for Cataract Surgery

Study Status: Completed
Recruit Status: Completed
Study Type: Interventional

Official Title: A Prospective, Randomized Study of Cataract Surgery With the Assistance of the OptiMedica Femtosecond Laser System Compared to Standard Surgical Procedure of Continuous Cu

Brief Summary: The purpose of this study is to evaluate the safety and efficacy of the OptiMedica Femtosecond Laser System to perform surgical maneuvers used in the treatment of subjects with cataracts. The safety and efficacy will be compared to the standard surgical procedure of continuous curvilinear capsulorhexis (CCC) and ultrasonic phacoemulsification.

Detailed Summary:
Sponsor: Abbott Medical Optics

Current Primary Outcome: Deviation From Intended Capsulotomy Diameter [ Time Frame: Day of Surgery ]

Capsulotomy diameter measured during surgery for both the experimental and control groups.


Original Primary Outcome:

Current Secondary Outcome: Cumulative Dissipated Energy (CDE) [ Time Frame: Day of Surgery ]

CDE (the amount of ultrasound energy delivered during phacoemulsification of the crystalline lens) used will be measured during surgery. CDE is a unit used for the Alcon Infinity System (the U/S phacoemulsification used in this study). It is not expressed in standard units such as watts or Joules. CDE, which accounts for the power and time of two ultrasound delivery modes (longitudinal and torsional), is calculated as follows:

CDE = (Phaco time x average phaco power) + (torsional time x average torsional aptitude x 0.4)

0.4 is a factor representing the approximate reduction of heat dissipated at the incision as compared to conventional phacoemulsification.



Original Secondary Outcome:

Information By: Abbott Medical Optics

Dates:
Date Received: February 13, 2010
Date Started: February 2010
Date Completion:
Last Updated: August 25, 2014
Last Verified: August 2014