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

This study has been completed.
Sponsor:
Information provided by:
Democritus University of Thrace
ClinicalTrials.gov Identifier:
NCT01298089
First received: February 16, 2011
Last updated: February 17, 2011
Last verified: February 2011
  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 ] [ Designated as safety issue: No ]
    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

Genders Eligible for Study:   Both
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
Please refer to this study by its ClinicalTrials.gov identifier: NCT01298089

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

Publications:
Responsible Party: Eleftherios Paschalis / PhD, Eye Institute of Thrace / Democritus University
ClinicalTrials.gov Identifier: NCT01298089     History of Changes
Other Study ID Numbers: Carriazo Pendular
Study First Received: February 16, 2011
Last Updated: February 17, 2011
Health Authority: Greece: Ethics Committee

Keywords provided by Democritus University of Thrace:
Flap
LASIK
Corneal

ClinicalTrials.gov processed this record on April 16, 2014