LASIK Using the Alcon Allegretto Wavefront-Guided Excimer Laser vs AMO Visx Wavefront-Guided Excimer Laser (LASIK)
|Myopia Astigmatism||Procedure: Wavefront-guided LASIK - Allegretto Procedure: Wavefront-guided LASIK - AMO||Phase 4|
|Study Design:||Allocation: Randomized
Intervention Model: Single Group Assignment
Masking: Open Label
Primary Purpose: Treatment
|Official Title:||A Prospective Eye to Eye Comparison of LASIK Using the Alcon Allegretto Wavefront-Guided Excimer Laser Versus AMO Visx Wavefront-Guided Excimer Laser|
- Efficacy [ Time Frame: 1 year ]Efficacy measures uncorrected visual acuity following the LASIK surgery. We will record how many eyes see 20/40, 20/30, 20/25, 20/20, 20/16, 20/12.5 and 20/10 after the surgery without glasses or contact lenses. We are measuring how well patients see after the surgery without glasses or contact lenses.
- Low contrast visual acuity [ Time Frame: 1 year ]Measuring changes in best spectacle corrected low contrast visual acuity (5 and 25 percent).
- Higher order aberrations [ Time Frame: 1 year ]Measure changes in higher order aberrations.
- Safety [ Time Frame: One year ]Will will assess safety by measuring change in best spectacle corrected visual acuity. We will record the number of eyes that gain, lose or have no change in the best spectacle corrected visual acuity after the surgery. This is measured using snellen visual acuity charts. The ideal outcome would be that there were no loss of any lines of best spectacle corrected visual acuity and a high percentage of gains of lines of best spectacle corrected visual acuity.
- Predictability [ Time Frame: One year ]Percentage of eyes within +/- 0.5 diopters of the intended correction
|Study Start Date:||June 2011|
|Estimated Study Completion Date:||December 2017|
|Estimated Primary Completion Date:||December 2017 (Final data collection date for primary outcome measure)|
Active Comparator: Wavefront-guided LASIK - Allegretto
Wavefront-guided LASIK using the Allegretto excimer laser.
Procedure: Wavefront-guided LASIK - Allegretto
Wavefront-guided LASIK using the Allegretto excimer laser for myopia.
Other Name: Alcon Wavelight Allegretto Eye-Q 400 Hz excimer laser
Active Comparator: Wavefront-guided LASIK - AMO
Wavefront-guided LASIK using AMO CustomVue excimer laser.
Procedure: Wavefront-guided LASIK - AMO
Wavefront-guided LASIK using the AMO CustomVue excimer laser for myopia.
Other Name: AMO Visx CustomVue S4 IR excimer laser
The patients will have a comprehensive eye examination once they express an interest in the study. This includes a slit lamp examination of the front of the eye and a dilated fundoscopic examination of the back of the eye. if there is any pathology noted that would exclude the patient from the study, then we will inform the patient and make an appropriate referral. If the patient is deemed appropriate for the study after a comprehensive examination included computerized videokeratography, then they can be enrolled. The patient will undergo bilateral simultaneous eye surgery. Which eye is treated with a wavefront-guided excimer laser and which eye is treated with wavefront-optimized will be randomized so there is a 50% chance for either eye to receive one treatment. The patients will be seen on the day of surgery, post op day one, post op day 4-7, one month, three months, six months and one year. The patient will receive topical antibiotics in each eye for one week following the procedure. LASIK treated eyes will receive pred forte 1% ophthalmic drops for one week after treatment. All of this is within the usual and customary standard of care for the treatment of patients undergoing lasik surgery.
The research procedures are the least risky that can be performed consistent with sound research design.
Please refer to this study by its ClinicalTrials.gov identifier: NCT01454843
|United States, California|
|Byers Eye Institute at Stanford|
|Palo Alto, California, United States, 94303|
|Principal Investigator:||Edward E Manche, MD||Stanford University|