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NCT00713856 Clinical Trial

Comparison of Conventional and Custom Photorefractive Keratectomy (PRK)

Myopia Clinical Trial

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

Clinical Trial Details — Status: Completed

Administrative data
NCT number NCT00713856
Other study ID # 25339
Secondary ID
Status Completed
Phase N/A
First received July 8, 2008
Last updated October 15, 2010
Start date November 2007
Est. completion date May 2010

Study information
Verified date October 2010
Source University of Utah
Contact n/a
Is FDA regulated No
Health authority United States: Institutional Review Board
Study type Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility
Status Completed
Enrollment 44
Est. completion date May 2010
Est. primary completion date December 2009
Accepts healthy volunteers No
Gender Both
Age group 18 Years to 80 Years
Eligibility Inclusion Criteria:

- Patients deemed to be suitable candidates for bilateral PRK

Exclusion Criteria:

- Patients desiring monovision correction rather than bilateral distance correction

Study Design

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

Related Conditions & MeSH terms

Intervention

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

Locations
Country Name City State
United States University of Utah, John Moran Eye Center Salt Lake City Utah

Sponsors (1)
Lead Sponsor Collaborator
University of Utah

Country where clinical trial is conducted

United States, 

Outcome
Type Measure Description Time frame Safety issue
Primary Visual acuity 6 months Yes
Secondary Manifest refraction 6 months No
Secondary Wavefront aberration value 6 months No
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