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Comparison of a Laser Keratome to a Mechanical Microkeratome

Primary Purpose

Myopia, Astigmatism, Myopic Astigmatism

Status

Completed

Phase

Not Applicable

Locations

Study Type

Interventional

Intervention

Amadeus Microkeratome

IntraLase

About this trial

This is an interventional treatment trial for Myopia

Eligibility Criteria

18 Years - undefined (Adult, Older Adult)All SexesDoes not accept healthy volunteers

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

Sites / Locations

Outcomes

Primary Outcome Measures

Visual acuity

Contrast sensitivity

Induction of high order aberration

Corneal sensation

Secondary Outcome Measures

Full Information

NCT ID

NCT00366574

First Posted

August 17, 2006

Last Updated

August 17, 2006

Sponsor

Medical University of South Carolina

1. Study Identification

Unique Protocol Identification Number

NCT00366574

Brief Title

Comparison of a Laser Keratome to a Mechanical Microkeratome

Official Title

Comparison of INTRALASE® to AMADEUS™ Microkeratome

Study Type

Interventional

2. Study Status

Record Verification Date

March 2005

Overall Recruitment Status

Completed

Study Start Date

September 2004 (undefined)

Primary Completion Date

undefined (undefined)

Study Completion Date

February 2005 (undefined)

3. Sponsor/Collaborators

Name of the Sponsor

Medical University of South Carolina

4. Oversight

5. Study Description

Brief Summary

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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study

Myopia, Astigmatism, Myopic Astigmatism

7. Study Design

Primary Purpose

Treatment

Study Phase

Not Applicable

Interventional Study Model

Parallel Assignment

Masking

Double

Allocation

Randomized

Enrollment

20 (false)

8. Arms, Groups, and Interventions

Intervention Type

Device

Intervention Name(s)

Amadeus Microkeratome

Intervention Type

Device

Intervention Name(s)

IntraLase

Primary Outcome Measure Information:

Title

Visual acuity

Title

Contrast sensitivity

Title

Induction of high order aberration

Title

Corneal sensation

10. Eligibility

Sex

All

Minimum Age & Unit of Time

18 Years

Accepts Healthy Volunteers

Eligibility Criteria

Overall Study Officials:

First Name & Middle Initial & Last Name & Degree

Kerry D. Solomon, MD

Organizational Affiliation

Medical University of South Carolina

Official's Role

Principal Investigator

12. IPD Sharing Statement

Learn more about this trial

Comparison of a Laser Keratome to a Mechanical Microkeratome

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