Comparison of a Laser Keratome to a Mechanical Microkeratome | NCT00366574

Studies
Comparison of a Laser Keratome to a Mechanical Microkeratome

NCT00366574

Sponsor

Medical University of South Carolina

Status

Completed

Last Update Posted

Aug 21, 2006Estimated

Enrollment

Phase

Not Applicable

Conditions

Myopia
Astigmatism
Myopic Astigmatism

Interventions

Amadeus Microkeratome
IntraLase

Countries

Not provided

Protocol Section

Identification Module Status Module Sponsor/Collaborators Module Oversight Module Description Module Conditions Module Design Module Arms/Interventions Module Outcomes Module Eligibility Module Contacts/Locations Module References Module IPD Sharing Statement Module

Results Section

Participant Flow Module Baseline Characteristics Module Outcome Measures Module Adverse Events Module More Info Module

Annotation Section

Annotation Module

Document Section

Large Document Module

Derived Section

Miscellaneous Info Module Condition Browse Module Intervention Browse Module

Protocol Section

Identification Module

NCT ID

Results Section

No data available

No data is available for this block.

Annotation Section

No data available

No data is available for this block.

Document Section

No data available

No data is available for this block.

Derived Section

Miscellaneous Info Module

Version Holder

Status Module

Record Verification Date

Mar 2005

Overall Recruitment Status or Expanded Access Status

Completed

Last Known Status

Not provided

Delayed Posting

Not provided

Why Stopped

Not provided

Expanded Access Info

Start Date

Sep 2004

Primary Completion Date

Not provided

Completion Date

Feb 2005

First Submitted Date

Aug 17, 2006

First Submission Date that Met QC Criteria

Aug 17, 2006

First Posted Date

Aug 21, 2006Estimated

Results Waived

Not provided

Results First Submitted Date

Not provided

Results First Submitted that Met QC Criteria

Not provided

Results First Posted Date

Not provided

Certification/Extension (aka Delayed Results) First Submitted Date

Not provided

Certification/Extension First Submitted that Passed QC Review

Not provided

Certification/Extension First Posted Date

Not provided

Last Update Submitted Date

Aug 17, 2006

Last Update Posted Date

Aug 21, 2006Estimated

Description Module

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.

Detailed Description

Not provided

Design Module

Study Type

Interventional

Number of References to an Expanded Access Study

Not provided

Expanded Access Types

Not provided

Patient Registry

Not provided

Target Follow-Up Duration

Not provided

Phases

Not Applicable

Interventional Study Design

Allocation

Biospecimen

No data available

No data is available for this block.

Enrollment

Outcomes Module

Primary Outcomes

Measure	Description	Time Frame
Visual acuity
Contrast sensitivity
Induction of high order aberration
Corneal sensation

Secondary Outcomes

Not provided

Other Outcomes

Not provided

Eligibility Module

Eligibility Criteria

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

Accepts Healthy Volunteers

Sex

All

Sex/Gender Based

Not provided

Sex/Gender Description

Not provided

Minimum Age

18 Years

Maximum Age

Not provided

Standard Ages

AdultOlder Adult

Study Population

Not provided

Sampling Method

Not provided

Contacts/Locations Module

Central Contacts

Not provided

Overall Officials

Name	Affiliation	Role
Kerry D. Solomon, MD	Medical University of South Carolina	Principal Investigator

Locations

Not provided

Condition Browse Module

MeSH Terms

ID	Term
D009216	Myopia
D001251	Astigmatism

Ancestor Terms

ID	Term
D012030	Refractive Errors
D005128	Eye Diseases

Browse Leaves

Not provided

Browse Branches

Not provided

Name	Type	Description	Arm Group Labels	Other Names
Amadeus Microkeratome	Device
IntraLase	Device