A Study of Cataract Surgery With the Femtosecond Laser
|The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.|
|ClinicalTrials.gov Identifier: NCT00922571|
Recruitment Status : Terminated (Sponsor decided not to pursue market release of prototype device used in this study)
First Posted : June 17, 2009
Last Update Posted : August 3, 2016
|Condition or disease||Intervention/treatment|
|Cataract||Procedure: FS Laser Surgery Device: FS Laser System|
|Study Type :||Interventional (Clinical Trial)|
|Actual Enrollment :||100 participants|
|Intervention Model:||Single Group Assignment|
|Masking:||None (Open Label)|
|Official Title:||A Study of Cataract Surgery With the Assistance of the Femtosecond Laser|
|Study Start Date :||June 2009|
|Primary Completion Date :||May 2014|
|Study Completion Date :||May 2014|
Experimental: FS Laser Surgery
For femtosecond laser-assisted cataract surgery (FS Laser Surgery), subjects will receive capsulotomy, lens segmentation and, at investigator discretion, lens softening using the OptiMedica Catalys™ Precision Laser System (Catalys System)
Procedure: FS Laser Surgery
The Catalys System is an ophthalmic surgical laser system intended for use in cataract surgery. The intervention consists of the both surgery and the use of the device.Device: FS Laser System
The Catalys System is an ophthalmic surgical laser system intended for use in cataract surgery. The intervention consists of the both surgery and the use of the device.
Other Name: OptiMedica Catalys™ Precision Laser System (Catalys System)
- Capsulotomy Size [ Time Frame: Day of Surgery ]Capsulotomy size will be measured during surgery.
- Cumulated 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.
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): NCT00922571
|Santo Domingo, Dominican Republic|
|Principal Investigator:||Juan F. Batlle, MD||Laser Center, Santo Domingo, Dominican Republic|