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OpenTrials
Completed

NCT Number: NCT01298089

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

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

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Key information

Conditions

Corneal Flap Thickness (Micrometers)

Sex eligibility

All sexes

Study type

Observational

Primary location

Eleftherios Paschalis

Alexandroupoli, Euros, 68100, Greece

Who can participate

Healthy volunteers accepted: Yes

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

Carriazo Pendular microkeratome

Device

Primary outcomes

  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).

Sponsors and collaborators

Lead sponsor

Democritus University of Thrace

Other

Registry information

Official study title

LASIK Flap Thickness Predictability With the Carriazo Pendular Microkeratome

Important dates

Study start
2006
Primary completion
2007
Study completion
2009
First posted
Feb 17, 2011
Registry last updated
Feb 18, 2011

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.