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

Corneal Flap Thickness (Micrometers) Clinical Trial

Official title:

LASIK Flap Thickness Predictability With the Carriazo Pendular Microkeratome

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT01298089
• Other study ID #: Carriazo Pendular
• Status: Completed
• Phase: N/A
• First received: February 16, 2011
• Last updated: February 17, 2011
• Start date: February 2006
• Est. completion date: February 2009

Study information

• Verified date: February 2011
• Source: Democritus University of Thrace
• Contact: n/a
• Is FDA regulated: No
• Health authority: Greece: Ethics Committee
• Study type: Observational

Clinical Trial 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).

Recruitment information / eligibility

• Status: Completed
• Enrollment: 131
• Est. completion date: February 2009
• Est. primary completion date: February 2007
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: Both
• Age group: N/A and older

Eligibility

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

Observational Model: Cohort, Time Perspective: Retrospective

Related Conditions & MeSH terms

• Corneal Flap Thickness (Micrometers)

Intervention

Device:
• Carriazo Pendular microkeratome

Locations

Country	Name	City	State
Greece	Eleftherios Paschalis	Alexandroupolis	Euros

Sponsors (1)

Lead Sponsor	Collaborator
Democritus University of Thrace

Country where clinical trial is conducted

Greece, 

References & Publications (3)

Alió JL, Piñero DP. Very high-frequency digital ultrasound measurement of the LASIK flap thickness profile using the IntraLase femtosecond laser and M2 and Carriazo-Pendular microkeratomes. J Refract Surg. 2008 Jan;24(1):12-23. — View Citation

Kymionis GD, Portaliou DM, Tsiklis NS, Panagopoulou SI, Pallikaris IG. Thin LASIK flap creation using the SCHWIND Carriazo-Pendular microkeratome. J Refract Surg. 2009 Jan;25(1):33-6. — View Citation

Paschalis EI, Aristeidou AP, Foudoulakis NC, Razis LA. Corneal flap assessment with Rondo microkeratome in laser in situ keratomileusis. Graefes Arch Clin Exp Ophthalmol. 2011 Feb;249(2):289-95. doi: 10.1007/s00417-010-1433-7. Epub 2010 Jun 25. — View Citation

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Corneal flap thickness (micrometers)	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).	6 months postoperatively	No