Clinical trial NCT01746589: Visual Outcomes and Contrast Sensitivity After Myopic LASIK
Official title: 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
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE4
Conditions: Myopia
Keywords: LASIK
Lead sponsor: Durrie Vision
Sponsor class: OTHER
Collaborators: name: Alcon Research
First posted: 2012-12-11
Enrollment: 22
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Allocation: NA
Intervention model: SINGLE_GROUP
Primary purpose: TREATMENT

Brief summary: 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.


Eligibility criteria: 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.

Primary outcomes:
measure: Change in Uncorrected Visual Acuity over time postoperatively
timeFrame: Postoperatively immediate (1-3 minutes), 30 minutes, 1 hour, 2 hours, 4 hours, 1 day, and 1 month
Secondary outcomes:
measure: Change in contrast sensitivity postoperatively as compared to baseline
timeFrame: Postoperatively at immediately (1-3 minutes) after surgery, 30 minutes, 1 hour, 2 hours, 4 hours, 1 day and 1 month
Other outcomes:
Locations:
city: Overland Park
country: United States
facility: Durrie Vision
state: Kansas
Study officials:
References: