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

A Single Center Prospective Evaluation of the Post-LASIK Flap Thickness of the FS200 Femtosecond Laser Flap

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.

Study Overview

• Status: Completed
• Conditions: Myopia
• Intervention / Treatment: Device: FS200 Femtosecond Laser

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 Type: Interventional
• Enrollment (Actual): 30
• Phase: Phase 4

Contacts and Locations

Study Locations

• United States
  • Kansas
    • Overland Park, Kansas, United States, 66211
      • Durrie Vision

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years and older (Adult, Older Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

Description

INCLUSION CRITERIA

The following are requirements for a potential study patient's inclusion into the study:

• Male or female in good general health, 18 years of age or older at the time of the pre-operative examination
• Patient must be able to read, comprehend and willing to give HIPPA and informed consent
• Patient is planning to undergo a bilateral LASIK procedure
• Both eyes must have a manifest refractive error from -1.00 to -7.00D spherical equivalent with less than or equal to 3.00 D of refractive astigmatism as expressed in spectacle minus cylinder form
• Both eyes must have a BSCVA of 20/25 or better
• Both eyes must demonstrate refractive stability confirmed by clinical records or previous glasses. Refractive stability shall be documented by a change of less than or equal to 0.50 diopter per year (sphere and cylinder) or as documented by clinical judgment by the investigator.

EXCLUSION CRITERIA

The following are exclusion criteria for study patients in this study:

• A patient with evidence of keratoconus, corneal irregularity, or abnormal videokeratography in either eye
• A patient requiring the use of any ocular drop(s) and/or medication(s) in either eye during the study period with the exception of ocular drops and/or medications provided by the investigator
• A patient having any surgical procedure within a week preceding the scheduled LASIK surgery
• A patient with any UNCONTROLLED systemic disease (i.e., a potential patient in whom therapy for a systemic disease is not yet stabilized )
• A patient with a history of prior intraocular or corneal surgery (including cataract extraction), clinically significant ophthalmic disease or abnormality (including, but not limited to, uncontrolled clinically significant blepharitis, clinically significant recurrent corneal erosion, clinically significant dry eye syndrome, clinically significant lens opacity, evidence of clinically significant trauma (including scarring inside the visual axis), or evidence of glaucoma or propensity for narrow angle glaucoma in either eye
• A patient with a significant history or current evidence of a medical, psychological or other disorder that, in the investigator's opinion, may increase the risk associated with study participation or may interfere with the interpretation of study results
• A patient with a history of any of the following medical conditions, or any other condition that could affect wound healing: uncontrolled diabetes, collagen vascular disease, autoimmune disease, immunodeficiency diseases, ocular herpes zoster or simplex, endocrine disorders (including, but not limited to unstable thyroid disorders and diabetes), lupus, and rheumatoid arthritis
• A female patient who is pregnant, nursing, planning a pregnancy during the study, or thinks she may be pregnant at the start of the study
• Current participation or participation within 30 days prior to the start of this study in a drug or other investigational device research study.

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: N/A
• Interventional Model: Single Group Assignment
• Masking: None (Open Label)

Number of Arms

1

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Other: FS200 Femtosecond Laser; The LASIK flap will be created using the FS200 Femtosecond Laser	Device: FS200 Femtosecond Laser

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Flap Thickness	The flap thickness will be measured one week postoperative using the Visante OCT and the Optivue OCT devices	1 Week Postoperative visit

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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	Postoperatively 1 month

Other Outcome Measures

Outcome Measure	Measure Description	Time Frame
Postoperative Satisfaction Survey over Time	Subject questionnaire will be administered to evaluate overall patient satisfaction postoperatively	Postoperatively Day 1, Week 1, Month 1

Collaborators and Investigators

• Sponsor: Durrie Vision
• Collaborators: Alcon Research

Study record dates

Study Major Dates

• Study Start: February 1, 2012
• Primary Completion (Actual): April 1, 2012
• Study Completion (Actual): April 1, 2012

Study Registration Dates

• First Submitted: September 21, 2012
• First Submitted That Met QC Criteria: September 24, 2012
• First Posted (Estimate): September 26, 2012

Study Record Updates

• Last Update Posted (Estimate): January 25, 2013
• Last Update Submitted That Met QC Criteria: January 24, 2013
• Last Verified: January 1, 2013

More Information

Terms related to this study

• Keywords: Myopia; Lasik; Femtosecond Laser
• Additional Relevant MeSH Terms: Eye Diseases; Refractive Errors; Myopia
• Other Study ID Numbers: FT-FS200-001

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No
• product manufactured in and exported from the U.S.: No