Comparison of Conventional and Custom Photorefractive Keratectomy (PRK)

This study has been completed.
Sponsor:
Information provided by:
University of Utah
ClinicalTrials.gov Identifier:
NCT00713856
First received: July 8, 2008
Last updated: October 15, 2010
Last verified: October 2010

July 8, 2008
October 15, 2010
November 2007
December 2009   (final data collection date for primary outcome measure)
Visual acuity [ Time Frame: 6 months ] [ Designated as safety issue: Yes ]
Same as current
Complete list of historical versions of study NCT00713856 on ClinicalTrials.gov Archive Site
  • Manifest refraction [ Time Frame: 6 months ] [ Designated as safety issue: No ]
  • Wavefront aberration value [ Time Frame: 6 months ] [ Designated as safety issue: No ]
Same as current
Not Provided
Not Provided
 
Comparison of Conventional and Custom Photorefractive Keratectomy (PRK)
Comparison of Conventional and Custom With Iris Registration PRK Ablations: Assessment of Visual Function and Patient Satisfaction

The study objective is to compare the clinical outcomes using wavefront guided PRK with iris registration and conventional laser PRK using FDA-approved laser technology on the same patient.

Patients undergoing bilateral PRK on the same day will have one eye randomly assigned to custom wavefront guided PRK and the fellow eye treated with conventional PRK.

Interventional
Not Provided
Allocation: Randomized
Endpoint Classification: Efficacy Study
Intervention Model: Parallel Assignment
Masking: Open Label
Primary Purpose: Treatment
Myopia
  • Procedure: Custom PRK with iris registration
    PRK
  • Procedure: Conventional PRK
    PRK
  • Active Comparator: 1
    Intervention: Procedure: Custom PRK with iris registration
  • Active Comparator: 2
    Intervention: Procedure: Conventional PRK
Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Completed
44
May 2010
December 2009   (final data collection date for primary outcome measure)

Inclusion Criteria:

  • Patients deemed to be suitable candidates for bilateral PRK

Exclusion Criteria:

  • Patients desiring monovision correction rather than bilateral distance correction
Both
18 Years to 80 Years
No
Contact information is only displayed when the study is recruiting subjects
United States
 
NCT00713856
25339
No
Mark Mifflin, MD, University of Utah
University of Utah
Not Provided
Principal Investigator: Mark Mifflin, MD University of Utah
University of Utah
October 2010

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP