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A Comparison of Fellow Eyes Undergoing LASIK or PRK With a Wavefront-guided Excimer Laser Versus a Wavefront-optimized Excimer Laser

Not Applicable
Completed
Conditions
Hyperopia
Astigmatism
Myopia
Interventions
Procedure: LASIK and PRK
Registration Number
NCT01135719
Lead Sponsor
Edward E. Manche
Brief 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.

Detailed 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.

Recruitment & Eligibility

Status
COMPLETED
Sex
All
Target Recruitment
137
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.

Study & Design

Study Type
INTERVENTIONAL
Study Design
SINGLE_GROUP
Arm && Interventions
GroupInterventionDescription
Wavefront guided LASIK/PRKLASIK and PRKWavefront-guided LASIK/PRK
Wavefront optimized LASIK/PRKLASIK and PRKWavefornt optimized LASIK/PRK
Primary Outcome Measures
NameTimeMethod
Changes in 25 and 5% low contrast visual acuity.One year
Improvement in uncorrected visual acuityOne year
Changes in best spectacle corrected visual acuity.One year
Secondary Outcome Measures
NameTimeMethod
Changes in higher order aberrations.One year
Topographic changes.One year
Quality of vision changes.One year

Trial Locations

Locations (1)

Stanford University School of Medicine

🇺🇸

Stanford, California, United States

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