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

Study Overview
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Brief Summary
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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
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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).

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

Conditions
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Refractive Errors

Intervention / Treatment
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* Procedure: LASIK
* Procedure: LASIK
* Procedure: LASIK


Participation Criteria
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Eligibility Criteria
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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

Ages Eligible for Study
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Minimum Age: 18 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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Accepts Healthy Volunteers

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Screening
Allocation: Non-Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: I<br>Corneal flaps were created with mechanical microkeratome (Hansatome 160μm (Chiron Vision Corp, Claremont, Calif) | Procedure: LASIK<br>* Mechanical microkeratome Hansatome 160 microns<br>|
| Experimental: II<br>Corneal flaps were created with mechanical microkeratome K3000 130μm ( BD Ophthalmic Systems, Waltham, Mass) . | Procedure: LASIK<br>* Mechanical microkeratome K 3000 130 microns<br>|
| Experimental: III<br>Corneal flaps were created with microkeratome femtoseconds laser (Intralase Corp, Irvine, Calif.) | Procedure: LASIK<br>* Femtoseconds laser 100 microns<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Measured thickness flap using Confocal microscopy study |  | 14 days after LASIK | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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LASIK, Confocal microscopy, Flap