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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

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

Status
Completed
Phases
NA
Study type
Interventional
Source
ClinicalTrials.gov
Registry ID
NCT04899258
Enrollment
30
Registered
2021-05-24
Start date
2019-12-12
Completion date
2020-07-15
Last updated
2021-05-24

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Anterior Chamber Inflammation, Cornea, Refractive Surgery

Keywords

Excimer laser Corneal Endothelium, Laser in situ keratomileusis (LASIK);, femtosecond assisted-LASIK, Anterior chamber flare, Endothelial cell densit, Corneal Endothelium

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.

Interventions

PROCEDUREFemtosecond laser assisted LASIK

Refractive surgery

Sponsors

Istanbul University
Lead SponsorOTHER

Study design

Allocation
NA
Intervention model
SINGLE_GROUP
Primary purpose
PREVENTION
Masking
NONE

Masking description

Patients name and identifiers were masked

Intervention model description

prospective, before-after study

Eligibility

Sex/Gender
ALL
Age
18 Years to 50 Years
Healthy volunteers
Yes

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

Design outcomes

Primary

MeasureTime frameDescription
Change of Flare ValuesThe change of flare values on first day, seventh day, 1. month and 3. months according to preoperative valuesTo measure anterior chamber inflammation objectively, Flare values were measured by the laser flare-photometry

Secondary

MeasureTime frameDescription
Change of Corneal endothelium features-1the changes of the parameters of preoperative and 3. months' valuesEndothelial cell density (ECD),(The parameter was measured by specular microscopy)

Other

MeasureTime frameDescription
Change of Corneal endothelium features-2the changes of the parameters of preoperative and 3. months' valuesCoefficient of Varience (CV) in cell size, (The parameter was measured by specular microscopy)
Change of Corneal endothelium features-3the changes of the parameters of preoperative and 3. months' valuesHexagonality percent of the cell shape. (The parameter was measured by specular microscopy)

Countries

Turkey (Türkiye)

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 14, 2026