Overview

This trial is active, not recruiting.

Conditions hyperopia, myopia, astigmatism
Treatment lasik and prk
Sponsor Edward E. Manche
Start date April 2009
End date December 2015
Trial size 200 participants
Trial identifier NCT01135719, SU-04302009-2458

Summary

Subjects with myopia, hyperopia and astigmatism are being randomized to be treated in one eye with a wavefront-guided excimer laser and their fellow eye treated with a wavefront-optimized excimer laser.

United States No locations recruiting
Other Countries No locations recruiting

Study Design

Allocation randomized
Endpoint classification safety/efficacy study
Intervention model single group assignment
Masking open label
Primary purpose treatment
Arm
(Active Comparator)
Wavefront-guided LASIK/PRK
lasik and prk Allegretto Wave Eye-Q 400 Hz excimer laser
Wavefront-guided versus wavefront-optimized LASIK or PRK.
(Active Comparator)
Wavefornt optimized LASIK/PRK
lasik and prk Allegretto Wave Eye-Q 400 Hz excimer laser
Wavefront-guided versus wavefront-optimized LASIK or PRK.

Primary Outcomes

Measure
Changes in best spectacle corrected visual acuity.
time frame: One year
Changes in 25 and 5% low contrast visual acuity.
time frame: One year
Improvement in uncorrected visual acuity
time frame: One year

Secondary Outcomes

Measure
Changes in higher order aberrations.
time frame: One year
Topographic changes.
time frame: One year
Quality of vision changes.
time frame: One year

Eligibility Criteria

Male or female participants at least 21 years old.

Inclusion Criteria: - Healthy subjects age 21 and older. - Subjects with nearsightedness, farsightedness and/or astigmatism. Exclusion Criteria:Autoimmune diseases. - Children. - Women pregnant or nursing. - Ectatic corneal disease. - Previous ocular surgery.

Additional Information

Official title A Prospective Randomized Comparison of Fellow Eyes Undergoing LASIK or PRK With a Wavefront-guided Excimer Laser Versus a Wavefront-optimized Excimer Laser
Principal investigator Edward E. Manche
Description Subjects with myopia, hyperopia and astigmatism are being randomized by ocular dominance to be treated with either PRK or LASIK. One eye will be treated with a wavefront-guided excimer laser and the fellow eye will be treated with a wavefront optimized excimer laser.
Trial information was received from ClinicalTrials.gov and was last updated in April 2015.
Information provided to ClinicalTrials.gov by Stanford University.