Evaluation of the Post-LASIK Flap Thickness of the FS200 Femtosecond Laser Flap

Phase 4

Completed

• Conditions: Myopia
• Interventions: Device: FS200 Femtosecond Laser

• Registration Number: NCT01693939
• Lead Sponsor: Durrie Vision

Brief Summary

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.

Detailed Description

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.

Study Timeline

• Study Start: 2012-02
• Primary Completion: 2012-04
• Study Completion: 2012-04
• Study First Submitted: 2012-09-21
• Study First Submitted QC: 2012-09-24
• Study First Posted: 2012-09-26
• Status Verified: 2013-01
• Last Update Submitted: 2013-01-24
• Last Update Posted: 2013-01-25

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 30

Inclusion Criteria

Not provided

Exclusion Criteria

Not provided

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: SINGLE_GROUP

Arm && Interventions

Group	Intervention	Description
FS200 Femtosecond Laser	FS200 Femtosecond Laser	The LASIK flap will be created using the FS200 Femtosecond Laser

Primary Outcome Measures

Name	Time	Method
Flap Thickness	1 Week Postoperative visit	The flap thickness will be measured one week postoperative using the Visante OCT and the Optivue OCT devices

Secondary Outcome Measures

Name	Time	Method
Change in Uncorrected Visual Acuity at 1 Day, 1 Week, and 1 Month Postoperatively	Postoperatively 1 month	Change in Uncorrected visual acuity will be measured at 1 Day, 1 week, and 1 month postoperatively

Trial Locations

Locations (1)

Durrie Vision; 🇺🇸 Overland Park, Kansas, United States