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
  Purpose

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.


Condition Intervention
Myopia
Procedure: Custom PRK with iris registration
Procedure: Conventional PRK

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Efficacy Study
Intervention Model: Parallel Assignment
Masking: Open Label
Primary Purpose: Treatment
Official Title: Comparison of Conventional and Custom With Iris Registration PRK Ablations: Assessment of Visual Function and Patient Satisfaction

Further study details as provided by University of Utah:

Primary Outcome Measures:
  • Visual acuity [ Time Frame: 6 months ] [ Designated as safety issue: Yes ]

Secondary Outcome Measures:
  • Manifest refraction [ Time Frame: 6 months ] [ Designated as safety issue: No ]
  • Wavefront aberration value [ Time Frame: 6 months ] [ Designated as safety issue: No ]

Enrollment: 44
Study Start Date: November 2007
Study Completion Date: May 2010
Primary Completion Date: December 2009 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Active Comparator: 1 Procedure: Custom PRK with iris registration
PRK
Active Comparator: 2 Procedure: Conventional PRK
PRK

Detailed Description:

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.

  Eligibility

Ages Eligible for Study:   18 Years to 80 Years
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

  • Patients deemed to be suitable candidates for bilateral PRK

Exclusion Criteria:

  • Patients desiring monovision correction rather than bilateral distance correction
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT00713856

Locations
United States, Utah
University of Utah, John Moran Eye Center
Salt Lake City, Utah, United States, 84132
Sponsors and Collaborators
University of Utah
Investigators
Principal Investigator: Mark Mifflin, MD University of Utah
  More Information

No publications provided

Responsible Party: Mark Mifflin, MD, University of Utah
ClinicalTrials.gov Identifier: NCT00713856     History of Changes
Other Study ID Numbers: 25339
Study First Received: July 8, 2008
Last Updated: October 15, 2010
Health Authority: United States: Institutional Review Board

ClinicalTrials.gov processed this record on October 21, 2014