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Clinical Trials/NCT01135719
NCT01135719
Completed
Not Applicable

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

Edward E. Manche1 site in 1 country137 target enrollmentApril 2009
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ConditionsHyperopiaMyopiaAstigmatism

Overview

Phase
Not Applicable
Intervention
Not specified
Conditions
Hyperopia
Sponsor
Edward E. Manche
Enrollment
137
Locations
1
Primary Endpoint
Changes in 25 and 5% low contrast visual acuity.
Status
Completed
Last Updated
3 years ago
OverviewInvestigatorsEligibility CriteriaOutcomesSitesSimilar Trials

Overview

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.

Registry
clinicaltrials.gov
Start Date
April 2009
End Date
December 3, 2022
Last Updated
3 years ago
Study Type
Interventional
Study Design
Single Group
Sex
All

Investigators

Sponsor
Edward E. Manche
Responsible Party
Sponsor Investigator
Principal Investigator

Edward E. Manche

Stanford University School of Medicine

Stanford University

Eligibility Criteria

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.

Outcomes

Primary Outcomes

Changes in 25 and 5% low contrast visual acuity.

Time Frame: One year

Improvement in uncorrected visual acuity

Time Frame: One year

Changes in best spectacle corrected visual acuity.

Time Frame: One year

Secondary Outcomes

  • Changes in higher order aberrations.(One year)
  • Topographic changes.(One year)
  • Quality of vision changes.(One year)

Study Sites (1)

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