A Study of Flap Thickness Results Using the Carriazo Pendular Microkeratome - 130 Micrometers Head.

February 17, 2011 updated by: Democritus University of Thrace

LASIK Flap Thickness Predictability With the Carriazo Pendular Microkeratome

A study of flap thickness predictability in patients submitted to Laser in Situ Keratomileusis (LASIK) with the Carriazo-Pendular microkeratome (130 micrometers head size).

Study Overview

Status

Completed

Conditions

Intervention / Treatment

Study Type

Observational

Enrollment (Actual)

131

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • Greece
    • Euros
      • Alexandroupolis, Euros, Greece, 68100
        • Eleftherios Paschalis

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

  • Child
  • Adult
  • Older Adult

Accepts Healthy Volunteers

Yes

Genders Eligible for Study

All

Sampling Method

Non-Probability Sample

Study Population

Patients submitted to LASER refractive correction at the Eye Institute of Thrace, Democritus University

Description

Inclusion Criteria:

  • LASIK candidates treated with the Carriazo-Pendular microkeratome - 130 micron head

Exclusion Criteria:

  • corneal irregularities > 3D
  • Thin corneal CCT < 460μm
  • Active anterior segment disease
  • Previous intraocular or corneal surgery
  • History of herpetic eye disease
  • Corneal scarring
  • Glaucoma
  • Severe dry eye
  • Topographic evidence of keratoconus

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Corneal flap thickness (micrometers)
Time Frame: 6 months postoperatively
Flap thickness was calculated by subtracting the preoperative central corneal thickness minus the intraoperative residual stromal thickness. All measurements were made using ultrasound pachymetry (non-interventional technique).
6 months postoperatively

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Democritus University of Thrace

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

February 1, 2006

Primary Completion (Actual)

February 1, 2007

Study Completion (Actual)

February 1, 2009

Study Registration Dates

First Submitted

February 16, 2011

First Submitted That Met QC Criteria

February 16, 2011

First Posted (Estimate)

February 17, 2011

Study Record Updates

Last Update Posted (Estimate)

February 18, 2011

Last Update Submitted That Met QC Criteria

February 17, 2011

Last Verified

February 1, 2011

More Information

Terms related to this study

Keywords

Other Study ID Numbers

  • Carriazo Pendular

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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Conditions

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Locations

3
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