Comparison of Conventional and Custom Photorefractive Keratectomy (PRK)

Not Applicable

Completed

• Conditions: Myopia
• Interventions: Procedure: Custom PRK with iris registration; Procedure: Conventional PRK

• Registration Number: NCT00713856
• Lead Sponsor: 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.

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 Timeline

• Study Start: 2007-11
• Study First Submitted: 2008-07-08
• Study First Submitted QC: 2008-07-11
• Study First Posted: 2008-07-14
• Primary Completion: 2009-12
• Study Completion: 2010-05
• Status Verified: 2010-10
• Last Update Submitted: 2010-10-15
• Last Update Posted: 2010-10-19

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 44

Inclusion Criteria

• Patients deemed to be suitable candidates for bilateral PRK

Exclusion Criteria

• Patients desiring monovision correction rather than bilateral distance correction

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
1	Custom PRK with iris registration	-
2	Conventional PRK	-

Primary Outcome Measures

Name	Time	Method
Visual acuity	6 months

Secondary Outcome Measures

Name	Time	Method
Manifest refraction	6 months
Wavefront aberration value	6 months

Trial Locations

Locations (1)

University of Utah, John Moran Eye Center; 🇺🇸 Salt Lake City, Utah, United States