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

Comparison of Photorefractive Keratectomy (PRK) and Sub-Bowman's Keratomileusis (SBK): Assessment of Visual Function and Patient Satisfaction

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

Study Overview

• Status: Completed
• Conditions: Myopia
• Intervention / Treatment: Procedure: PRK; Procedure: SBK

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 Type: Interventional
• Enrollment (Actual): 60
• Phase: Not Applicable

Contacts and Locations

Study Locations

• United States
  • Utah
    • Salt Lake City, Utah, United States, 84106
      • University of Utah, John Moran Eye Center

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 21 years to 80 years (Adult, Older Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

Description

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 Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: None (Open Label)

Number of Arms

2

Arms and Interventions

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

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Time Frame
Visual acuity	6 months

Secondary Outcome Measures

Outcome Measure	Time Frame
Manifest refraction	6 months
Wavefront aberration value	6 months

Collaborators and Investigators

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

Study record dates

Study Major Dates

• Study Start: October 1, 2007
• Primary Completion (Actual): September 1, 2010
• Study Completion (Actual): September 1, 2010

Study Registration Dates

• First Submitted: July 8, 2008
• First Submitted That Met QC Criteria: July 11, 2008
• First Posted (Estimate): July 14, 2008

Study Record Updates

• Last Update Posted (Estimate): September 16, 2010
• Last Update Submitted That Met QC Criteria: September 14, 2010
• Last Verified: September 1, 2010

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Eye Diseases; Refractive Errors; Myopia
• Other Study ID Numbers: 25516