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Comparison of Conventional and Custom Photorefractive Keratectomy (PRK)

This study has been completed.
Sponsor:
ClinicalTrials.gov Identifier:
NCT00713856
First Posted: July 14, 2008
Last Update Posted: October 19, 2010
The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
Information provided by:
University of Utah
  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
Intervention Model: Parallel Assignment
Masking: None (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 ]

Secondary Outcome Measures:
  • Manifest refraction [ Time Frame: 6 months ]
  • Wavefront aberration value [ Time Frame: 6 months ]

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

Information from the National Library of Medicine

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, Learn About Clinical Studies.


Ages Eligible for Study:   18 Years to 80 Years   (Adult, Senior)
Sexes Eligible for Study:   All
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
Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): 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

Responsible Party: Mark Mifflin, MD, University of Utah
ClinicalTrials.gov Identifier: NCT00713856     History of Changes
Other Study ID Numbers: 25339
First Submitted: July 8, 2008
First Posted: July 14, 2008
Last Update Posted: October 19, 2010
Last Verified: October 2010


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