Comparison of a Laser Keratome to a Mechanical Microkeratome

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

20 participants

Study Classification

INTERVENTIONAL

Study Start Date

2004-09-30

Study Completion Date

2005-02-28

Brief Summary

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The purpose of this study was to evaluate the performance of the INTRALASE®, a laser keratome which creates a corneal flap, and compare it to a mechanical microkeratome (Amadeus™). Our hypothesis is that there is no difference between the 2 devices.

Detailed Description

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Conditions

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Myopia Astigmatism Myopic Astigmatism

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

TREATMENT

Blinding Strategy

DOUBLE

Interventions

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Amadeus Microkeratome

Intervention Type DEVICE

IntraLase

Intervention Type DEVICE

Eligibility Criteria

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Inclusion Criteria

* Candidate for bilateral wavefront-guided LASIK
* Myopia up to -7.00 D
* Astigmatism of 0.00 to -1.50 D

Exclusion Criteria

* History of ocular pathology
* Previous ocular surgery
* Very large pupils (greater than 8mm diameter, infrared measurement)
* Thin corneas (preoperatively calculated minimal residual bed \< 250 um)
* Irregular astigmatism
* Asymmetric astigmatism
* Unstable refraction
* Any other criteria that precludes subject to undergo LASIK

Minimum Eligible Age

18 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Principal Investigators

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Kerry D. Solomon, MD

Role: PRINCIPAL_INVESTIGATOR

Medical University of South Carolina

Other Identifiers

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MRC-05-003

Identifier Type: -

Identifier Source: org_study_id