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Clinical Trials/NCT00713856
NCT00713856CompletedNot Applicable

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

University of Utah1 site in 1 country44 target enrollmentStarted: November 1, 2007Last updated:
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Conditions
Interventions

Trial Snapshot

Phase
Not Applicable
Status
Completed
Enrollment
44
Locations
1
Primary Endpoint
Visual acuity
Study OverviewStudy DesignEligibility CriteriaArms & InterventionsOutcomesInvestigatorsSitesRecords & IdentifiersSimilar Trials

Study Overview

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 Design

Study Type
Interventional
Allocation
Randomized
Intervention Model
Parallel
Primary Purpose
Treatment
Masking
None

Eligibility Criteria

Ages
18 Years to 80 Years (Adult, Older Adult)
Sex
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

Arms & Interventions

1

Active Comparator

Intervention: Custom PRK with iris registration (Procedure)

2

Active Comparator

Intervention: Conventional PRK (Procedure)

Outcomes

Primary Outcomes

Visual acuity

Time Frame: 6 months

Secondary Outcomes

  • Manifest refraction(6 months)
  • Wavefront aberration value(6 months)

Investigators

Sponsor Class
Other

Study Sites (1)

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