A Prospective Randomized Comparison of the AMO CustomVue to the Alcon Wavelight in Patients Undergoing LASIK
Overview
- Phase
- Not Applicable
- Intervention
- Not specified
- Conditions
- Nearsightedness
- Sponsor
- Stanford University
- Enrollment
- 100
- Locations
- 1
- Primary Endpoint
- Uncorrected visual acuity
- Status
- Completed
- Last Updated
- last year
Overview
Brief Summary
The investigators are comparing outcomes of LASIK surgery using a high definition wavefront-guided laser to a wavefront-optimized laser in patients with nearsightedness with and without astigmatism.
Detailed Description
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 the investigators 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 the CustomVue and which eye is treated with Wavelight 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, one month, three months, six months and one year. The patient will receive topical antibiotics in each eye for one week following the procedure. The patient will receive pred forte 1% ophthalmic drops for one week after treatment. The patient will also receive vigamox ophthalmic drops for four days after treatment. All of this is within the usual and customary standard of care for the treatment of patients undergoing LASIK surgery.
Investigators
Edward E. Manche
Principal Investigator
Stanford University
Eligibility Criteria
Inclusion Criteria
- Not provided
Exclusion Criteria
- Not provided
Outcomes
Primary Outcomes
Uncorrected visual acuity
Time Frame: Twelve months
Secondary Outcomes
- Quality of vision and quality of life using the QoV questionnaire(One month, three months, six months and twelve months)
- Change in best spectacle corrected visual acuity(One, three, six and twelve months)
- Vector analysis of astigmatic outcomes (The Alpins method looking at Target induced astigmatism, Surgical induced astigmatism, Index of Success(One, three six and twelve months)
- Predictability of refractive outcomes (Percentage of eyes +/- 0.25 diopters, +/- 0.50 diopters and +/- 1.00 diopters of the intended correction)(One, three, six and twelve months)
- Changes in higher order aberrations (Coma, trefoil, spherical aberration, total higher order RMS)(One day, one month, three months, six months and twelve months)