Overview

This trial is active, not recruiting.

Conditions myopia, astigmatism
Treatments wavefront-guided lasik, wavefront-optimized lasik
Sponsor Edward E. Manche
Start date April 2010
End date December 2015
Trial size 50 participants
Trial identifier NCT01138189, SU-05272010-6188, Stanford Protocol # 18692

Summary

The purpose of the study is to compare the results of LASIK surgery when using wavefront-guided excimer laser treatment compared to wavefront optimized excimer laser treatment in patients with nearsightedness with and without astigmatism

United States No locations recruiting
Other Countries No locations recruiting

Study Design

Observational model case control
Time perspective prospective

Primary Outcomes

Measure
Changes in best corrected visual acuity
time frame: 12 months
Changes in 5 and 25% contrast visual acuity
time frame: 12 months
Refractive predictability
time frame: 12 months
Uncorrected visual acuity
time frame: 12 months

Secondary Outcomes

Measure
Changes in higher order aberrations
time frame: 1 yr
Quality of vision measurement
time frame: 1 yr
Topographic analysis
time frame: 1 yr

Eligibility Criteria

Male or female participants at least 21 years old.

Inclusion Criteria: - Subjects age 21 and older with healthy eyes. - Nearsightedness between -7.50 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 autoimmune diseases. - Patients who are pregnant or nursing. - Patients must have similar levels of nearsightedness in each eye. They can not be more than 3.0 diopter of difference between eyes. - Patients must have similar levels of astigmatism in each eye. They can not have more than 4.0 diopters of difference in nearsightedness or astigmatism between their two eyes.

Additional Information

Official title A Prospective Eye to Eye Comparison of LASIK Using Wavefront-guided Treatment Versus Wavefront-optimized Treatment
Principal investigator Edward E. Manche
Description This is a research study comparing the outcomes of LASIK surgery for nearsightedness when using the two different excimer laser technologies. Patients will have both eyes treated with the Alcon WaveLight Allegretto excimer laser. You will be one of 150 sighted patients at Stanford to undergo treatment in this clinical research trial. This will be a prospective, randomized, research study in which up to 300 consecutive eyes scheduled to undergo excimer laser in situ keratomileusis (LASIK) using one laser technology in the first eye and the second laser technology in the fellow eye for the correction of myopia (nearsightedness) with or without astigmatism will be enrolled. The choice of which eye receives the wavefront guided technology and which eye receives the wavefront-optimized technology will be randomized prior to enrollment. Randomization will be done according to a randomization schedule. You will know which eye is being treated with which each technology. The randomization will determine only whether your right or left eye is treated with the wavefront guided technology. The other eye will be treated with wavefront-optimized laser technology. You have a fifty percent chance of having your left eye treated with custom wavefront guided technology as your right eye. Subjects will undergo bilateral (both eyes at once) LASIK treatments using the Alcon WaveLight Allegretto excimer laser. All subjects will be followed for one year after the vision correction procedure. Subjects scheduled to undergo LASIK for the correction of myopia (nearsightedness) with or without astigmatism will be screened for eligibility. Eligible subjects will be examined preoperatively to establish a baseline for ocular condition (the general health and glasses prescription of the eyes). Postoperatively, subjects will undergo an ophthalmic evaluation (complete eye examination) at regular intervals as specified in this protocol. Retreatments (a second operation on the same eye for residual nearsightedness) will not be allowed during the first twelve months of this study. If you elect to undergo a retreatment of your LASIK surgery prior to the 12-month post-operative visit, the retreated eye will be exited from the study as of the retreatment date. Any significant new finding developed during the course of the research which may relate to the subject's willingness to continue participation will be provided to the subject or subject's representative in a timely manner.
Trial information was received from ClinicalTrials.gov and was last updated in April 2015.
Information provided to ClinicalTrials.gov by Stanford University.