Comparison of Conventional and Custom Photorefractive Keratectomy (PRK)

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. Identifier: NCT00713856
Recruitment Status : Completed
First Posted : July 14, 2008
Last Update Posted : October 19, 2010
Information provided by:
University of Utah

Brief Summary:
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 or disease Intervention/treatment Phase
Myopia Procedure: Custom PRK with iris registration Procedure: Conventional PRK Not Applicable

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.

Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 44 participants
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
Study Start Date : November 2007
Actual Primary Completion Date : December 2009
Actual Study Completion Date : May 2010

Arm Intervention/treatment
Active Comparator: 1 Procedure: Custom PRK with iris registration

Active Comparator: 2 Procedure: Conventional PRK

Primary Outcome Measures :
  1. Visual acuity [ Time Frame: 6 months ]

Secondary Outcome Measures :
  1. Manifest refraction [ Time Frame: 6 months ]
  2. Wavefront aberration value [ Time Frame: 6 months ]

Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years to 80 Years   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No

Inclusion Criteria:

  • Patients deemed to be suitable candidates for bilateral PRK

Exclusion Criteria:

  • Patients desiring monovision correction rather than bilateral distance correction

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 identifier (NCT number): NCT00713856

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

Responsible Party: Mark Mifflin, MD, University of Utah Identifier: NCT00713856     History of Changes
Other Study ID Numbers: 25339
First Posted: July 14, 2008    Key Record Dates
Last Update Posted: October 19, 2010
Last Verified: October 2010