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

Asociación para Evitar la Ceguera en México

Status: Terminated

Conditions: Refractive Errors

Treatments: Procedure: LASIK

Study type: Interventional

Funder types: Other

Identifiers

NCT00558324

Cornea 1

Details and patient eligibility

About

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

Full 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).

Enrollment: 43 patients

Sex: All

Ages: 18+ years old

Volunteers: Accepts Healthy Volunteers

Inclusion criteria

• Patients ask for LASIK surgery
• Patients with stable refraction in the last year
• Patients without systemic and ocular disease
• Patients with 500 microns in pachymetry
• Normal topography

Exclusion criteria

• Patients cannot attend their appointments
• Residual, recurrent or active ocular disease
• Previous ocular surgery except LASIK
• Autoimmune or connective tissue disease
• Pregnancy

Trial design

Primary purpose: Screening

Allocation: Non-Randomized

Interventional model: Parallel Assignment

Masking: None (Open label)

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43 participants in 3 patient groups

I

Experimental group

Description:

Corneal flaps were created with mechanical microkeratome (Hansatome 160μm (Chiron Vision Corp, Claremont, Calif)

Treatment:

Procedure: LASIK

Procedure: LASIK

Procedure: LASIK

II

Experimental group

Description:

Corneal flaps were created with mechanical microkeratome K3000 130μm ( BD Ophthalmic Systems, Waltham, Mass) .

Treatment:

Procedure: LASIK

Procedure: LASIK

Procedure: LASIK

III

Experimental group

Description:

Corneal flaps were created with microkeratome femtoseconds laser (Intralase Corp, Irvine, Calif.)

Treatment:

Procedure: LASIK

Procedure: LASIK

Procedure: LASIK