Comparison of LASIK and SBK

• Sponsor: University of Utah (Other)
• Overall Status: Completed
• CT.gov ID: NCT00714363
• Collaborator: (none)
• Enrollment: 40
• Location: 1
• Arms: 2
• Duration (Months): 27
• Patients Per Site Per Month: 1.5

Study Details

Study Description

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

Condition or Disease	Intervention/Treatment	Phase
Myopia	Procedure: LASIK; Procedure: SBK	N/A

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
• Actual Enrollment: 40 participants
• Allocation: Randomized
• Intervention Model: Parallel Assignment
• Masking: None (Open Label)
• Primary Purpose: Treatment
• Official Title: Comparison of Laser-Assisted in Situ Keratomeleusis (LASIK) vs Sub-Bowman's Keratomileusis (SBK): Assessment of Visual Function and Patient Satisfaction
• Study Start Date: Oct 1, 2007
• Actual Primary Completion Date: Dec 1, 2008
• Actual Study Completion Date: Jan 1, 2010

Arms and Interventions

Arm	Intervention/Treatment
Active Comparator: 1 LASIK	Procedure: LASIK; Refractive surgery
Active Comparator: 2 SBK	Procedure: SBK; Refractive surgery

Outcome Measures

Primary Outcome Measures

1. Visual acuity [6 months]

Secondary Outcome Measures

1. Manifest refraction [6 months]

2. Wavefront aberration value [6 months]

Eligibility Criteria

Criteria

• Ages Eligible for Study: 21 Years to 80 Years
• Sexes Eligible for Study: 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

Contacts and Locations

Locations

	Site	City	State	Country	Postal Code
1	University of Utah, John Moran Eye Center	Salt Lake City	Utah	United States	84132

Sponsors and Collaborators

• University of Utah

Investigators

• Principal Investigator: Majid Moshirfar, MD, University of Utah

Study Documents (Full-Text)

None provided.

More Information

Publications

None provided.

• ClinicalTrials.gov Identifier: NCT00714363
• Other Study ID Numbers: 25514
• First Posted: Jul 14, 2008
• Last Update Posted: Oct 19, 2010
• Last Verified: Oct 1, 2010

• Additional relevant MeSH terms: Myopia

Study Results

No Results Posted as of Oct 19, 2010