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
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

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 July 24, 2014