NCT00366574

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.

Trial Health

100
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
20

participants targeted

Target at below P25 for not_applicable

Timeline
Completed

Started Sep 2004

Shorter than P25 for not_applicable

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

September 1, 2004

Completed
5 months until next milestone

Study Completion

Last participant's last visit for all outcomes

February 1, 2005

Completed
1.5 years until next milestone

First Submitted

Initial submission to the registry

August 17, 2006

Completed
4 days until next milestone

First Posted

Study publicly available on registry

August 21, 2006

Completed
Last Updated

August 21, 2006

Status Verified

March 1, 2005

First QC Date

August 17, 2006

Last Update Submit

August 17, 2006

Conditions

MyopiaAstigmatismMyopic Astigmatism

Outcome Measures

Primary Outcomes (4)

  • Visual acuity

  • Contrast sensitivity

  • Induction of high order aberration

  • Corneal sensation

Interventions

Amadeus MicrokeratomeDEVICE
IntraLaseDEVICE

Eligibility Criteria

Age18 Years+
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

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

You may not qualify if:

  • 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

Contact the study team to confirm eligibility.

Sponsors & Collaborators

MeSH Terms

Conditions

MyopiaAstigmatism

Condition Hierarchy (Ancestors)

Refractive ErrorsEye Diseases

Study Officials

  • Kerry D. Solomon, MD

    Medical University of South Carolina

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
DOUBLE
Purpose
TREATMENT
Intervention Model
PARALLEL
Sponsor Type
OTHER

Study Record Dates

First Submitted

August 17, 2006

First Posted

August 21, 2006

Study Start

September 1, 2004

Study Completion

February 1, 2005

Last Updated

August 21, 2006

Record last verified: 2005-03