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

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. Identifier: NCT01298089
Recruitment Status : Completed
First Posted : February 17, 2011
Last Update Posted : February 18, 2011
Information provided by:
Democritus University of Thrace

Brief Summary:
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 or disease Intervention/treatment
Corneal Flap Thickness (Micrometers) Device: Carriazo Pendular microkeratome

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Study Type : Observational
Actual Enrollment : 131 participants
Observational Model: Cohort
Time Perspective: Retrospective
Official Title: LASIK Flap Thickness Predictability With the Carriazo Pendular Microkeratome
Study Start Date : February 2006
Actual Primary Completion Date : February 2007
Actual Study Completion Date : February 2009

Primary Outcome Measures :
  1. 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).

Information from the National Library of Medicine

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Ages Eligible for Study:   Child, Adult, Older Adult
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

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

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 identifier (NCT number): NCT01298089

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Eleftherios Paschalis
Alexandroupolis, Euros, Greece, 68100
Sponsors and Collaborators
Democritus University of Thrace
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Responsible Party: Eleftherios Paschalis / PhD, Eye Institute of Thrace / Democritus University Identifier: NCT01298089    
Other Study ID Numbers: Carriazo Pendular
First Posted: February 17, 2011    Key Record Dates
Last Update Posted: February 18, 2011
Last Verified: February 2011
Keywords provided by Democritus University of Thrace: