Evaluation of the Post-LASIK Flap Thickness of the FS200 Femtosecond Laser Flap
Status: | Completed |
---|---|
Conditions: | Ocular |
Therapuetic Areas: | Ophthalmology |
Healthy: | No |
Age Range: | 18 - Any |
Updated: | 10/14/2017 |
Start Date: | February 2012 |
End Date: | April 2012 |
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.
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.
FS 200 Femtosecond laser flap during the LASIK procedure using the Visante and OptiVue OCT
ultrasound devices.
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.
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