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Comparison of Conventional and Custom Photorefractive Keratectomy (PRK)

NCT ID: NCT00713856

Last Updated: 2010-10-19

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

NA

Total Enrollment

44 participants

Study Classification

INTERVENTIONAL

Study Start Date

2007-11-30

Study Completion Date

2010-05-31

Brief Summary

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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

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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.

Conditions

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Myopia

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

TREATMENT

Blinding Strategy

NONE

Study Groups

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1

Group Type ACTIVE_COMPARATOR

Custom PRK with iris registration

Intervention Type PROCEDURE

PRK

2

Group Type ACTIVE_COMPARATOR

Conventional PRK

Intervention Type PROCEDURE

PRK

Interventions

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Custom PRK with iris registration

PRK

Intervention Type PROCEDURE

Conventional PRK

PRK

Intervention Type PROCEDURE

Eligibility Criteria

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Inclusion Criteria

* Patients deemed to be suitable candidates for bilateral PRK

Exclusion Criteria

* Patients desiring monovision correction rather than bilateral distance correction
Minimum Eligible Age

18 Years

Maximum Eligible Age

80 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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University of Utah

OTHER

Sponsor Role lead

Responsible Party

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University of Utah

Principal Investigators

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Mark Mifflin, MD

Role: PRINCIPAL_INVESTIGATOR

University of Utah

Locations

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University of Utah, John Moran Eye Center

Salt Lake City, Utah, United States

Site Status

Countries

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United States

Other Identifiers

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25339

Identifier Type: -

Identifier Source: org_study_id