Visual Outcomes and Contrast Sensitivity After Myopic LASIK

Completed · Phase 4

Conditions studied: Myopia

In brief

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.

Key facts

Study ID

NCT01746589

Run by

Daniel S. Durrie, MD

People needed

22

Starts

2011-11-01

Expected to finish

2012-01-01

Last updated by the study team

2013-01-28

Who can join

Age: 18 and older. Sex: any. Healthy volunteers: accepted.

You may qualify if…

• 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.

You may not qualify if…

• 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.

Where it is running

• Durrie Vision — Overland Park, Kansas, United States

Full record on ClinicalTrials.gov

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