Evaluation of the Effect of Myopic Femtosecond Laser Assisted-LASIK on Anterior Chamber Flare Values and Corneal Endothelial Cells: A Prospective Before-and-After Study

Study Overview
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Brief Summary
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This study aimed to investigate whether femtosecond laser-assisted LASIK (FS-LASIK) surgery causes inflammation in the anterior chamber and to analyze its effect on endothelial cells.

Detailed Description
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Since FS-LASIK surgery is applied using both an FS laser and an excimer laser, we aimed to determine the direct and indirect effects of these applications on the corneal endothelium, the intensity of the inflammation, and the blood-aqueous barrier in the anterior chamber. To the best of our knowledge, the effects of FS-LASIK on anterior chamber inflammation have not been previously investigated. Therefore, we evaluated these effects using objective measurement methods, such as specular microscopy and laser flare photometry.

Official Title
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Effect of Myopic Femtosecond Laser Asssisted-LASIK on Anaterior Chamber Flare Values and Corneal Endothelial Cells

Conditions
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Cornea, Refractive Surgery, Anterior Chamber Inflammation

Intervention / Treatment
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* Procedure: Femtosecond laser assisted LASIK


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: The patients who performed Femtosecond laser assisted LASIK for myopia or myopic astigmatism. Uncomplicated surgery Exclusion Criteria: Complicated surgery, Hyperopic or hyperopic astigmatism Lack of follow-up measurements

Ages Eligible for Study
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Minimum Age: 18 Years
Maximum Age: 50 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: Prevention
Intervention Model: Single Group Assignment
Interventional Model Description: prospective, before-after study
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Other: Pre-surgery and post-surgery<br>femtosecond assisted LASIK | Procedure: Femtosecond laser assisted LASIK<br>* Refractive surgery<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Change of Flare Values | To measure anterior chamber inflammation objectively, Flare values were measured by the laser flare-photometry | The change of flare values on first day, seventh day, 1. month and 3. months according to preoperative values | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Change of Corneal endothelium features-1 | Endothelial cell density (ECD),(The parameter was measured by specular microscopy) | the changes of the parameters of preoperative and 3. months' values | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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Excimer laser Corneal Endothelium, Laser in situ keratomileusis (LASIK);, femtosecond assisted-LASIK, Anterior chamber flare, Endothelial cell densit, Corneal Endothelium