Visual Outcomes and Contrast Sensitivity After Myopic LASIK
This study has been completed.
Information provided by (Responsible Party):
Daniel S. Durrie, MD, Durrie Vision
First received: December 7, 2012
Last updated: January 25, 2013
Last verified: January 2013
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.
Device: bilateral myopic LASIK
||Endpoint Classification: Efficacy Study
Intervention Model: Single Group Assignment
Masking: Open Label
Primary Purpose: Treatment
||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
Primary Outcome Measures:
- Change in Uncorrected Visual Acuity over time postoperatively [ Time Frame: Postoperatively immediate (1-3 minutes), 30 minutes, 1 hour, 2 hours, 4 hours, 1 day, and 1 month ] [ Designated as safety issue: No ]
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 Outcome Measures:
- Change in contrast sensitivity postoperatively as compared to baseline [ Time Frame: Postoperatively at immediately (1-3 minutes) after surgery, 30 minutes, 1 hour, 2 hours, 4 hours, 1 day and 1 month ] [ Designated as safety issue: No ]
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.
| Study Start Date:
| Study Completion Date:
| Primary Completion Date:
||January 2012 (Final data collection date for primary outcome measure)
myopic LASIK procedure
All subjects will receive bilateral myopic LASIK procedure using the 200 kHz WaveLight® FS200 Femtosecond Laser and the WaveLight® Allegretto Wave® Eye-Q Laser
Device: bilateral myopic LASIK
200 kHz WaveLight® FS200 Femtosecond Laser and the WaveLight® Allegretto Wave® Eye-Q Laser
Other Name: WaveLight® Femtosecond Laser and WaveLight® Allegretto®
|Ages Eligible for Study:
||18 Years and older
|Genders Eligible for Study:
|Accepts Healthy Volunteers:
- 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.
- 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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Please refer to this study by its ClinicalTrials.gov identifier: NCT01746589
|Overland Park, Kansas, United States, 66211 |
Daniel S. Durrie, MD
No publications provided
||Daniel S. Durrie, MD, President, Durrie Vision
History of Changes
|Other Study ID Numbers:
|Study First Received:
||December 7, 2012
||January 25, 2013
||United States: Institutional Review Board
Keywords provided by Durrie Vision:
ClinicalTrials.gov processed this record on October 22, 2014