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

This study has been completed.
Sponsor:
ClinicalTrials.gov Identifier:
NCT01298089
First Posted: February 17, 2011
Last Update Posted: February 18, 2011
The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
Information provided by:
Democritus University of Thrace
  Purpose
A study of flap thickness predictability in patients submitted to Laser in Situ Keratomileusis (LASIK) with the Carriazo-Pendular microkeratome (130 micrometers head size).

Condition Intervention
Corneal Flap Thickness (Micrometers) Device: Carriazo Pendular microkeratome

Study Type: Observational
Study Design: Observational Model: Cohort
Time Perspective: Retrospective
Official Title: LASIK Flap Thickness Predictability With the Carriazo Pendular Microkeratome

Further study details as provided by Democritus University of Thrace:

Primary Outcome Measures:
  • 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).


Enrollment: 131
Study Start Date: February 2006
Study Completion Date: February 2009
Primary Completion Date: February 2007 (Final data collection date for primary outcome measure)
  Eligibility

Information from the National Library of Medicine

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Ages Eligible for Study:   Child, Adult, Senior
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   Yes
Sampling Method:   Non-Probability Sample
Study Population
Patients submitted to LASER refractive correction at the Eye Institute of Thrace, Democritus University
Criteria

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
  Contacts and Locations
Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT01298089


Locations
Greece
Eleftherios Paschalis
Alexandroupolis, Euros, Greece, 68100
Sponsors and Collaborators
Democritus University of Thrace