NCT00558324

Corneal Flap Thickness Planed vs Measured After LASIK by Using Tree Different Systems Cut

• Status: Terminated
• Phase: N/A
• Study type: Interventional
• Enrollment: 43 (actual)
• Sponsor: Asociación para Evitar la Ceguera en México · Academic / Other
• Sex: All
• Age: 18 Years
• Healthy volunteers: Accepted

Summary

Determine the flap thickness created by femtosecond laser or a mechanical microkeratome using in vivo confocal microscopy and compare measured versus intended flap thickness.

Detailed description

Eighty-six eyes had undergone LASIK were examined, al within 2 weeks to 1 month after surgery. Study involved 3 treatment groups: One with 30 eyes of 15 patients, corneal flaps were created with the microkeratome femtosecond laser 15 KHz 100μm (Intralase Corp, Irvine, Calif.), one with 30 eyes of 15 patients, corneal flaps were created with mechanical microkeratome (Hansatome 160μm (Chiron Vision Corp, Claremont, Calif) and one with 26 eyes of 13 patients, corneal flaps were created with mechanical microkeratome K3000 130μm ( BD Ophthalmic Systems, Waltham, Mass) . A central scan of the total corneal thickness was taken with the confocal microscope (Confoscan 4, Fortune Technologies, Italy) before and at 2 weeks and 1 month after surgery. Corneal epithelial thickness and the Anterior stroma morphology were analyzed by using the NAVIS software V. 3.5.0 (NIDEK, Multi-Instrument Diagnostic System, Japan).

Conditions

• Refractive Errors

Interventions

Type	Name	Description
PROCEDURE	LASIK	Mechanical microkeratome Hansatome 160 microns
PROCEDURE	LASIK	Mechanical microkeratome K 3000 130 microns
PROCEDURE	LASIK	Femtoseconds laser 100 microns

Timeline

• Start date: 2007-02-01
• Primary completion: 2007-02-01
• Completion: 2007-10-01
• First posted: 2007-11-14
• Last updated: 2024-05-30

Locations

1 site across 1 country: Mexico