Comparison of Photorefractive Keratectomy (PRK) and Sub-Bowman's Keratomileusis (SBK)

• Sponsor: University of Utah (Other)
• Overall Status: Completed
• CT.gov ID: NCT00714922
• Collaborator: (none)
• Enrollment: 60
• Location: 1
• Arms: 2
• Duration (Months): 35
• Patients Per Site Per Month: 1.7

Study Details

Study Description

Brief Summary

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

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

Detailed Description

Patients undergoing bilateral laser refractive surgery on the same day will be randomly assigned to have one eye treated with PRK and the fellow eye treated with SBK.

Study Design

• Study Type: Interventional
• Actual Enrollment: 60 participants
• Allocation: Randomized
• Intervention Model: Parallel Assignment
• Masking: None (Open Label)
• Primary Purpose: Treatment
• Official Title: Comparison of Photorefractive Keratectomy (PRK) and Sub-Bowman's Keratomileusis (SBK): Assessment of Visual Function and Patient Satisfaction
• Study Start Date: Oct 1, 2007
• Actual Primary Completion Date: Sep 1, 2010
• Actual Study Completion Date: Sep 1, 2010

Arms and Interventions

Arm	Intervention/Treatment
Active Comparator: 1 PRK	Procedure: PRK; Laser refractive surgery
Active Comparator: 2 SBK	Procedure: SBK; Laser 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	84106

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: NCT00714922
• Other Study ID Numbers: 25516
• First Posted: Jul 14, 2008
• Last Update Posted: Sep 16, 2010
• Last Verified: Sep 1, 2010

• Additional relevant MeSH terms: Myopia

Study Results

No Results Posted as of Sep 16, 2010