Myopia
Conditions
Keywords
LASIK
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.
Interventions
DEVICEbilateral myopic LASIK
200 kHz WaveLight® FS200 Femtosecond Laser and the WaveLight® Allegretto Wave® Eye-Q Laser
Sponsors
Alcon Research
Daniel S. Durrie, MD
Study design
Allocation
NA
Intervention model
SINGLE_GROUP
Primary purpose
TREATMENT
Masking
NONE
Eligibility
Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
Yes
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.
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Change in Uncorrected Visual Acuity over time postoperatively | Postoperatively immediate (1-3 minutes), 30 minutes, 1 hour, 2 hours, 4 hours, 1 day, and 1 month | Change in uncorrected visual acuity from baseline, postoperatively, immediately(1-3 minutes) after surgery, 30 minutes, 1 hour, 2 hours, 4 hours, 1 day, and 1 month. |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Change in contrast sensitivity postoperatively as compared to baseline | Postoperatively at immediately (1-3 minutes) after surgery, 30 minutes, 1 hour, 2 hours, 4 hours, 1 day and 1 month | Contrast sensitivity (ability to distinguish between shades of gray) will be measured postoperatively immediately (1-3 minutes) after surgery, 30 minutes,1 hour, 2 hours, 4 hours, 1 day, and 1 month. |
Countries
United States
Outcome results
None listed