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NCT04899258 Clinical Trial

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

Cornea Clinical Trial

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

Clinical Trial Details — Status: Completed

Administrative data
NCT number NCT04899258
Other study ID # 06.12.2019/20/1495
Secondary ID
Status Completed
Phase N/A
First received
Last updated
Start date December 12, 2019
Est. completion date July 15, 2020

Study information
Verified date May 2021
Source Istanbul University
Contact n/a
Is FDA regulated No
Health authority
Study type Interventional

Clinical Trial Summary

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.

Description:

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.

Recruitment information / eligibility
Status Completed
Enrollment 30
Est. completion date July 15, 2020
Est. primary completion date March 14, 2020
Accepts healthy volunteers Accepts Healthy Volunteers
Gender All
Age group 18 Years to 50 Years
Eligibility 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

Study Design

Related Conditions & MeSH terms

Intervention

Procedure:
• Femtosecond laser assisted LASIK
Refractive surgery

Locations
Country Name City State
Turkey Istanbul Faculty of Medicine Fatih Istanbul

Sponsors (1)
Lead Sponsor Collaborator
Istanbul University

Country where clinical trial is conducted

Turkey, 

Outcome
Type Measure Description Time frame Safety issue
Other Change of Corneal endothelium features-2 Coefficient of Varience (CV) in cell size, (The parameter was measured by specular microscopy) the changes of the parameters of preoperative and 3. months' values
Other Change of Corneal endothelium features-3 Hexagonality percent of the cell shape. (The parameter was measured by specular microscopy) the changes of the parameters of preoperative and 3. months' values
Primary 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 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
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