Corneal Incisions With the IntraLase iFS Femtosecond Laser System
|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: NCT01713660|
Recruitment Status : Completed
First Posted : October 25, 2012
Results First Posted : May 29, 2013
Last Update Posted : June 12, 2013
|Condition or disease||Intervention/treatment||Phase|
|Cataract||Device: iFS Femtosecond Laser||Not Applicable|
|Study Type :||Interventional (Clinical Trial)|
|Actual Enrollment :||37 participants|
|Intervention Model:||Single Group Assignment|
|Masking:||None (Open Label)|
|Official Title:||A MULTI-CENTER PROSPECTIVE STUDY TO EVALUATE THE USE OF THE INTRALASE iFS™ FEMTOSECOND LASER SYSTEM TO CREATE CLEAR CORNEAL INCISIONS AND PARACENTESIS INCISIONS FOR CATARACT SURGERY|
|Study Start Date :||November 2012|
|Actual Primary Completion Date :||December 2012|
|Actual Study Completion Date :||January 2013|
|FS Corneal Incisions||
Device: iFS Femtosecond Laser
corneal incisions created by the femtosecond laser
- Demonstration That the Femtosecond Laser Consistently Produces Desired Incisions. [ Time Frame: Day 0, Operative (Within 2 hours of incision creation) ]Evaluation of incisions created as programmed and measurement in mm. Data reported will be based on intended incision size (as programmed) vs. achieved incision size (as measured).
- Surgeon Assessment of Workflow [ Time Frame: Day 0, Operative ]Surgeon questionnaire (completed at the end of each surgery and the end of each surgical day): Were incisions created as intended?
- Percent of Seidel Staining [ Time Frame: Day 0 (performed immediately post-incision creation), Day 1 ]Demonstration of no wound leakage as measured by Seidel test at slit lamp with fluorscein dye. A negative Seidel test result indicates no wound leakage.
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): NCT01713660
|United States, Indiana|
|Eye Surgeons of Indiana|
|Indianapolis, Indiana, United States, 46256|
|United States, Ohio|
|Cleveland Eye Clinic|
|Cleveland, Ohio, United States, 44141|