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

History of Changes

Tracking Information

First Received Date ^ICMJE

July 8, 2008

Last Updated Date

October 15, 2010

Start Date ^ICMJE

November 2007

Primary Completion Date

December 2009 (final data collection date for primary outcome measure)

Current Primary Outcome Measures ^ICMJE

Visual acuity [ Time Frame: 6 months ] [ Designated as safety issue: Yes ]

Original Primary Outcome Measures ^ICMJE

Same as current

Change History

Complete list of historical versions of study NCT00713856 on ClinicalTrials.gov Archive Site

Current Secondary Outcome Measures ^ICMJE

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

Original Secondary Outcome Measures ^ICMJE

Same as current

Current Other Outcome Measures ^ICMJE

Not Provided

Original Other Outcome Measures ^ICMJE

Not Provided

Descriptive Information

Brief Title ^ICMJE

Comparison of Conventional and Custom Photorefractive Keratectomy (PRK)

Official Title ^ICMJE

Comparison of Conventional and Custom With Iris Registration PRK Ablations: Assessment of Visual Function and Patient Satisfaction

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.

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 ^ICMJE

Interventional

Study Phase

Not Provided

Study Design ^ICMJE

Allocation: Randomized
Endpoint Classification: Efficacy Study
Intervention Model: Parallel Assignment
Masking: Open Label
Primary Purpose: Treatment

Condition ^ICMJE

Myopia

Intervention ^ICMJE

Procedure: Custom PRK with iris registration
PRK
Procedure: Conventional PRK
PRK

Study Arm (s)

Active Comparator: 1
Intervention: Procedure: Custom PRK with iris registration
Active Comparator: 2
Intervention: Procedure: Conventional PRK

Publications *

Not Provided

* Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.

Recruitment Information

Recruitment Status ^ICMJE

Completed

Enrollment ^ICMJE

Completion Date

May 2010

Primary Completion Date

December 2009 (final data collection date for primary outcome measure)

Eligibility Criteria ^ICMJE

Inclusion Criteria:

Patients deemed to be suitable candidates for bilateral PRK

Exclusion Criteria:

Patients desiring monovision correction rather than bilateral distance correction

Gender

Both

Ages

18 Years to 80 Years

Accepts Healthy Volunteers

Contacts ^ICMJE

Contact information is only displayed when the study is recruiting subjects

Location Countries ^ICMJE

United States

Administrative Information

NCT Number ^ICMJE

NCT00713856

Other Study ID Numbers ^ICMJE

25339

Has Data Monitoring Committee

Responsible Party

Mark Mifflin, MD, University of Utah

Study Sponsor ^ICMJE

University of Utah

Collaborators ^ICMJE

Not Provided

Investigators ^ICMJE

Principal Investigator:

Mark Mifflin, MD

University of Utah

Information Provided By

University of Utah

Verification Date

October 2010

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

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