Study of the Femtosecond Laser System as Compared to Continuous Curvilinear Capsulorhexis for Cataract Surgery
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|ClinicalTrials.gov Identifier: NCT01069172|
Recruitment Status : Completed
First Posted : February 17, 2010
Results First Posted : September 4, 2014
Last Update Posted : September 4, 2014
|Condition or disease||Intervention/treatment||Phase|
|Cataract||Device: FS Laser Surgery Procedure: CCC Surgery||Phase 3|
|Study Type :||Interventional (Clinical Trial)|
|Actual Enrollment :||30 participants|
|Intervention Model:||Parallel Assignment|
|Masking:||None (Open Label)|
|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 Curvilinear Capsulorhexis and Ultrasonic Phacoemulsification|
|Study Start Date :||February 2010|
|Actual Primary Completion Date :||July 2010|
|Actual Study Completion Date :||August 2010|
Experimental: FS Laser Surgery
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.
Device: FS Laser Surgery
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.
Other Name: OptiMedica Catalys™ Precision Laser System (Catalys System) = femtosecond laser; Alcon Infiniti System = U/S (ultrasound) phacoemulsification system
Active Comparator: CCC Surgery
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.
Procedure: CCC Surgery
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.
Other Name: Alcon Infiniti System = U/S (ultrasound) phacoemulsification system.
- Deviation From Intended Capsulotomy Diameter [ Time Frame: Day of Surgery ]Capsulotomy diameter measured during surgery for both the experimental and control groups.
- 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.
To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT01069172
|Santo Domingo, Dominican Republic|
|Principal Investigator:||Juan F Batlle, MD||Laser Center|
|Study Director:||William W Culberston, MD||Bascom Palmer Eye Institute|