Visual Outcomes and Contrast Sensitivity After Myopic LASIK
Status: | Completed |
---|---|
Conditions: | Ocular |
Therapuetic Areas: | Ophthalmology |
Healthy: | No |
Age Range: | 18 - Any |
Updated: | 10/14/2017 |
Start Date: | November 2011 |
End Date: | January 2012 |
Evaluation Of Visual Outcomes and Contrast Sensitivity After Myopic Wavefront-Optimized Lasik Using the 200 KHZ WAVELIGHT® FS200 Femtosecond Laser and the WAVELIGHT® ALLEGRETTO WAVE® EYE-Q Laser
Evaluate visual outcomes and contrast sensitivity for subjects undergoing bilateral myopic
LASIK procedure using the 200 kHz WaveLight® FS200 Femtosecond Laser and the WaveLight®
Allegretto Wave® Eye-Q Laser. The use of advanced technology may decrease the loss of
contrast sensitivity and improvement of postoperative visual acuity results.
LASIK procedure using the 200 kHz WaveLight® FS200 Femtosecond Laser and the WaveLight®
Allegretto Wave® Eye-Q Laser. The use of advanced technology may decrease the loss of
contrast sensitivity and improvement of postoperative visual acuity results.
INCLUSION CRITERIA
- 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 D to -7.00 spherical
equivalent with less than or equal to 3.00D of refractive astigmatism as expressed in
spectacle minus cylinder form
- Both eyes must have a BSCVA of 20/20 or better
- Both eyes must demonstrate refractive stability confirmed by clinical records,
previous glasses, or investigator's discretion.
- Patient must be willing to comply with study dosing and complete the entire course of
the study.
EXCLUSION CRITERIA
- A patient with evidence of keratoconus, corneal irregularity, or abnormal
videokeratography in either eye
- A patient seeking monovision
- A patient with a known hypersensitivity to any of the components of the procedural or
post-LASIK medications
- 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), active clinically significant ophthalmic disease or abnormality
(including, but not limited to, blepharitis, recurrent corneal erosion, dry eye
syndrome, neovascularization > 1mm from limbus), clinically significant lens opacity,
clinical evidence of 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
- Current participation or participation within 30 days prior to the start of this study
in a drug or other investigational research study.
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