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.
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study.
To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below.
For general information, see Learn About Clinical Studies.
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 March 31, 2015