Comparison of Conventional and Custom Photorefractive Keratectomy (PRK)

• Sponsor: University of Utah (Other)
• Overall Status: Completed
• CT.gov ID: NCT00713856
• Collaborator: (none)
• Enrollment: 44
• Location: 1
• Arms: 2
• Duration (Months): 30
• Patients Per Site Per Month: 1.5

Study Details

Study Description

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	N/A

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 Design

• Study Type: Interventional
• 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: Nov 1, 2007
• Actual Primary Completion Date: Dec 1, 2009
• Actual Study Completion Date: May 1, 2010

Arms and Interventions

Arm	Intervention/Treatment
Active Comparator: 1	Procedure: Custom PRK with iris registration; PRK
Active Comparator: 2	Procedure: Conventional PRK; PRK

Outcome Measures

Primary Outcome Measures

1. Visual acuity [6 months]

Secondary Outcome Measures

1. Manifest refraction [6 months]

2. Wavefront aberration value [6 months]

Eligibility Criteria

Criteria

• Ages Eligible for Study: 18 Years to 80 Years
• 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

Contacts and Locations

Locations

	Site	City	State	Country	Postal Code
1	University of Utah, John Moran Eye Center	Salt Lake City	Utah	United States	84132

Sponsors and Collaborators

• University of Utah

Investigators

• Principal Investigator: Mark Mifflin, MD, University of Utah

Study Documents (Full-Text)

None provided.

More Information

Publications

None provided.

• ClinicalTrials.gov Identifier: NCT00713856
• Other Study ID Numbers: 25339
• First Posted: Jul 14, 2008
• Last Update Posted: Oct 19, 2010
• Last Verified: Oct 1, 2010

• Additional relevant MeSH terms: Myopia

Study Results

No Results Posted as of Oct 19, 2010