A Phase 4 interventional study of FS200 Femtosecond Laser in Myopia, sponsored by Durrie Vision. Completed at 1 site in United States. Open to participants aged 18 Years and older, including healthy volunteers. Per ClinicalTrials.gov, last updated 2013-01-25.
Sponsored by Durrie Vision · Phase 4, Interventional, and Treatment
The purpose of this study is to document the programmed flap thickness to achieved flap thickness using the FS200 femtosecond laser in performing LASIK procedure. The FS200 Femtosecond laser is a precision surgical device that is used to create a flap in a FDA approved LASIK procedure.
The objective of this study is to evaluate the thickness of the corneal flap created with the FS 200 Femtosecond laser flap during the LASIK procedure using the Visante and OptiVue OCT ultrasound devices.
984 studies on the registry are indexed under Myopia; 210 are open to participants now.
This study's enrollment of 30 is below the median of 80 across 783 interventional studies indexed under Myopia.
Browse Myopia studies →Durrie Vision is the lead sponsor of 6 studies on the registry; none are open to participants now.
Counted across the registry records on this site, refreshed daily.
The following are requirements for a potential study patient's inclusion into the study:
EXCLUSION CRITERIA
The following are exclusion criteria for study patients in this study:
The LASIK flap will be created using the FS200 Femtosecond Laser
Device: FS200 Femtosecond Laser
Flap Thickness
The flap thickness will be measured one week postoperative using the Visante OCT and the Optivue OCT devices
Time frame: 1 Week Postoperative visit
Change in Uncorrected Visual Acuity at 1 Day, 1 Week, and 1 Month Postoperatively
Change in Uncorrected visual acuity will be measured at 1 Day, 1 week, and 1 month postoperatively
Time frame: Postoperatively 1 month
Postoperative Satisfaction Survey over Time
Subject questionnaire will be administered to evaluate overall patient satisfaction postoperatively
Time frame: Postoperatively Day 1, Week 1, Month 1
This study is completed, as verified in Jan 2013. You cannot join it, but the record below documents what was studied.
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