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Clinical Trials/NCT00714363
NCT00714363CompletedNot Applicable

Comparison of Laser-Assisted in Situ Keratomeleusis (LASIK) vs Sub-Bowman's Keratomileusis (SBK): Assessment of Visual Function and Patient Satisfaction

University of Utah1 site in 1 country40 target enrollmentStarted: October 1, 2007Last updated:
Conditions
Interventions

Trial Snapshot

Phase
Not Applicable
Status
Completed
Enrollment
40
Locations
1
Primary Endpoint
Visual acuity

Study Overview

Brief Summary

The objective of the study is to compare clinical outcomes from LASIK and SBK using FDA-approved laser technology on the same patient

Detailed Description

Patients undergoing bilateral refractive surgery on the same day will have one eye randomized to LASIK and the fellow eye assigned to SBK treatment.

Study Design

Study Type
Interventional
Allocation
Randomized
Intervention Model
Parallel
Primary Purpose
Treatment
Masking
None

Eligibility Criteria

Ages
21 Years to 80 Years (Adult, Older Adult)
Sex
All
Accepts Healthy Volunteers
No

Inclusion Criteria

  • •Patients deemed to be suitable candidates for bilateral LASIK surgery

Exclusion Criteria

  • •Patients who desire monovision correction rather than bilateral distance correction

Arms & Interventions

1

Active Comparator

LASIK

Intervention: LASIK (Procedure)

2

Active Comparator

SBK

Intervention: SBK (Procedure)

Outcomes

Primary Outcomes

Visual acuity

Time Frame: 6 months

Secondary Outcomes

  • Manifest refraction(6 months)
  • Wavefront aberration value(6 months)

Investigators

Sponsor Class
Other

Study Sites (1)

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