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

Not Applicable

Completed

• Conditions: Cornea; Anterior Chamber Inflammation; Refractive Surgery
• Interventions: Procedure: Femtosecond laser assisted LASIK

• Registration Number: NCT04899258
• Lead Sponsor: Istanbul University

Brief 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.

Detailed 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.

Study Timeline

• Study Start: 2019-12-12
• Primary Completion: 2020-03-14
• Study Completion: 2020-07-15
• Status Verified: 2021-05
• Study First Submitted: 2021-05-10
• Study First Submitted QC: 2021-05-19
• Last Update Submitted: 2021-05-19
• Study First Posted: 2021-05-24
• Last Update Posted: 2021-05-24

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 30

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

• Study Type: INTERVENTIONAL
• Study Design: SINGLE_GROUP

Arm && Interventions

Group	Intervention	Description
Pre-surgery and post-surgery	Femtosecond laser assisted LASIK	femtosecond assisted LASIK

Primary Outcome Measures

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

Secondary Outcome Measures

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

Trial Locations

Locations (1)

Istanbul Faculty of Medicine; 🇹🇷 Fatih, Istanbul, Turkey