This trial is active, not recruiting.

Conditions myopia, astigmatism
Treatments wavefront-guided lasik - allegretto, wavefront-guided lasik - amo
Phase phase 4
Sponsor Stanford University
Start date June 2011
End date December 2017
Trial size 60 participants
Trial identifier NCT01454843, 21220


The purpose of the study is to compare the results of LASIK surgery when using Alcon Allegretto wavefront-guided excimer laser system compared to AMO Visx Custom wavefront-guided excimer laser system in patients with nearsightedness with and without astigmatism.

United States No locations recruiting
Other countries No locations recruiting

Study Design

Allocation randomized
Endpoint classification efficacy study
Intervention model single group assignment
Masking open label
Primary purpose treatment
(Active Comparator)
Wavefront-guided LASIK using the Allegretto excimer laser.
wavefront-guided lasik - allegretto Alcon Wavelight Allegretto Eye-Q 400 Hz excimer laser
Wavefront-guided LASIK using the Allegretto excimer laser for myopia.
(Active Comparator)
Wavefront-guided LASIK using AMO CustomVue excimer laser.
wavefront-guided lasik - amo AMO Visx CustomVue S4 IR excimer laser
Wavefront-guided LASIK using the AMO CustomVue excimer laser for myopia.

Primary Outcomes

time frame: 1 year

Secondary Outcomes

Low contrast visual acuity
time frame: 1 year
Higher order aberrations
time frame: 1 year
time frame: One year
time frame: One year

Eligibility Criteria

Male or female participants from 21 years up to 60 years old.

Inclusion Criteria: - Subjects age 21 and older with healthy eyes. - Nearsightedness between -0.50 diopters and -7.00 diopters with or without astigmatism of up to 3.50 diopters. Exclusion Criteria: - Subjects under the age of 21. - Patients with excessively thin corneas. - Patients with topographic evidence of keratoconus. - Patients with ectatic eye disorders. - Patients with autoimmune diseases. - Patients who are pregnant or nursing. - Patients must have similar levels of nearsightedness with or without astigmatism in each eye. - They can not be more than 1.5 diopters of difference between eyes. - Patients must have similar levels of astigmatism in each eye. - They can not have more than 1.5 diopters of difference in nearsightedness or astigmatism between their two eyes.

Additional Information

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
Principal investigator Edward E Manche, MD
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 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.
Trial information was received from ClinicalTrials.gov and was last updated in April 2016.
Information provided to ClinicalTrials.gov by Stanford University.