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NCT00714363 Clinical Trial

Comparison of LASIK and SBK

Myopia Clinical Trial

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

Clinical Trial Details — Status: Completed

Administrative data
NCT number NCT00714363
Other study ID # 25514
Secondary ID
Status Completed
Phase N/A
First received July 8, 2008
Last updated October 15, 2010
Start date October 2007
Est. completion date January 2010

Study information
Verified date October 2010
Source University of Utah
Contact n/a
Is FDA regulated No
Health authority United States: Institutional Review Board
Study type Interventional

Clinical Trial Summary

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

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.

Recruitment information / eligibility
Status Completed
Enrollment 40
Est. completion date January 2010
Est. primary completion date December 2008
Accepts healthy volunteers No
Gender Both
Age group 21 Years to 80 Years
Eligibility Inclusion Criteria:

- Patients deemed to be suitable candidates for bilateral LASIK surgery

Exclusion Criteria:

- Patients who desire monovision correction rather than bilateral distance correction

Study Design

Allocation: Randomized, Endpoint Classification: Efficacy Study, Intervention Model: Parallel Assignment, Masking: Open Label, Primary Purpose: Treatment

Related Conditions & MeSH terms

Intervention

Procedure:
• LASIK
Refractive surgery
• SBK
Refractive surgery

Locations
Country Name City State
United States University of Utah, John Moran Eye Center Salt Lake City Utah

Sponsors (1)
Lead Sponsor Collaborator
University of Utah

Country where clinical trial is conducted

United States, 

Outcome
Type Measure Description Time frame Safety issue
Primary Visual acuity 6 months Yes
Secondary Manifest refraction 6 months No
Secondary Wavefront aberration value 6 months No
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