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

Completed

• Conditions: Corneal Flap Thickness (Micrometers)

• Registration Number: NCT01298089
• Lead Sponsor: 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).

Detailed Description

Not available

Study Timeline

• Study Start: 2006-02
• Primary Completion: 2007-02
• Study Completion: 2009-02
• Status Verified: 2011-02
• Study First Submitted: 2011-02-16
• Study First Submitted QC: 2011-02-16
• Study First Posted: 2011-02-17
• Last Update Submitted: 2011-02-17
• Last Update Posted: 2011-02-18

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 131

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

Study & Design

• Study Type: OBSERVATIONAL
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
Corneal flap thickness (micrometers)	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).

Trial Locations

Locations (1)

Eleftherios Paschalis; 🇬🇷 Alexandroupolis, Euros, Greece