Expired Study
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Salt Lake City, Utah 84132


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.


Study summary:

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.


Criteria:

Inclusion Criteria: - Patients deemed to be suitable candidates for bilateral PRK Exclusion Criteria: - Patients desiring monovision correction rather than bilateral distance correction


Study is Available At:


Original ID:

25339


NCT ID:

NCT00713856


Secondary ID:


Study Acronym:


Brief Title:

Comparison of Conventional and Custom Photorefractive Keratectomy (PRK)


Official Title:

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


Overall Status:

Completed


Study Phase:

N/A


Genders:

Both


Minimum Age:

18 Years


Maximum Age:

80 Years


Quick Facts

Healthy Volunteers
Oversight Has DMC
Study Is FDA Regulated
Study Is Section 801
Has Expanded Access

Study Source:

University of Utah


Oversight Authority:

United States: Institutional Review Board


Reasons Why Stopped:


Study Type:

Interventional


Study Design:

Allocation: Randomized, Endpoint Classification:


Number of Arms:

2


Number of Groups:

0


Total Enrollment:

44


Enrollment Type:

Actual


Overall Contact Information

Official Name:Mark Mifflin, MD
Principal Investigator
University of Utah

Study Dates

Start Date:November 2007
Completion Date:May 2010
Completion Type:Actual
Primary Completion Date:December 2009
Primary Completion Type:Actual
Verification Date:October 2010
Last Changed Date:October 15, 2010
First Received Date:July 8, 2008

Study Outcomes

Outcome Type:Primary Outcome
Measure:Visual acuity
Time Frame:6 months
Safety Issues:True
Outcome Type:Secondary Outcome
Measure:Manifest refraction
Time Frame:6 months
Safety Issues:False
Outcome Type:Secondary Outcome
Measure:Wavefront aberration value
Time Frame:6 months
Safety Issues:False

Study Interventions

Intervention Type:Procedure
Name:Custom PRK with iris registration
Description:PRK
Arm Name:1
Intervention Type:Procedure
Name:Conventional PRK
Description:PRK
Arm Name:2

Study Arms

Study Arm Type:Active Comparator
Arm Name:1
Study Arm Type:Active Comparator
Arm Name:2

Study Agencies

Agency Class:Other
Agency Type:Lead Sponsor
Agency Name:University of Utah

Sample and Retention Information

There are no available Sample and Retention Information

Study References

There are no available Study References

Data Source: ClinicalTrials.gov

Date Processed: October 09, 2019

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