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

Not Applicable

Terminated

• Conditions: Refractive Errors
• Interventions: Procedure: LASIK

• Registration Number: NCT00558324
• Lead Sponsor: Asociación para Evitar la Ceguera en México

Brief 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).

Study Timeline

• Study Start: 2007-02
• Primary Completion: 2007-02
• Study Completion: 2007-10
• Study First Submitted: 2007-11-07
• Study First Submitted QC: 2007-11-12
• Study First Posted: 2007-11-14
• Status Verified: 2024-05
• Last Update Submitted: 2024-05-29
• Last Update Posted: 2024-05-30

Recruitment & Eligibility

• Status: TERMINATED
• Sex: All
• Target Recruitment: 43

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

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
III	LASIK	Corneal flaps were created with microkeratome femtoseconds laser (Intralase Corp, Irvine, Calif.)
II	LASIK	Corneal flaps were created with mechanical microkeratome K3000 130μm ( BD Ophthalmic Systems, Waltham, Mass) .
I	LASIK	Corneal flaps were created with mechanical microkeratome (Hansatome 160μm (Chiron Vision Corp, Claremont, Calif)

Primary Outcome Measures

Name	Time	Method
Measured thickness flap using Confocal microscopy study	14 days after LASIK

Trial Locations

Locations (1)

Asociación Para Evitar la Ceguera en Mëxico, Hospital "Luis Sánchez Bulnes".; 🇲🇽 México city, Distrito Federal, Mexico