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Completed

NCT Number: NCT04899258

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

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.

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Key information

Conditions

Cornea Anterior Chamber Inflammation Corneal Diseases Eye Diseases Refractive Surgery

Age range

18 year–50 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Istanbul Faculty of Medicine

Fatih, Istanbul, Turkey (Türkiye)

About this study

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.

Who can participate

Healthy volunteers accepted: Yes

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

Femtosecond laser assisted LASIK

Procedure

Refractive surgery

Primary outcomes

  1. Change of Flare Values

    Time frame: 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 outcomes

  1. Change of Corneal endothelium features-1

    Time frame: the changes of the parameters of preoperative and 3. months' values

    Endothelial cell density (ECD),(The parameter was measured by specular microscopy)

Other outcomes

  1. Change of Corneal endothelium features-2

    Time frame: the changes of the parameters of preoperative and 3. months' values

    Coefficient of Varience (CV) in cell size, (The parameter was measured by specular microscopy)

  2. Change of Corneal endothelium features-3

    Time frame: the changes of the parameters of preoperative and 3. months' values

    Hexagonality percent of the cell shape. (The parameter was measured by specular microscopy)

Sponsors and collaborators

Lead sponsor

Istanbul University

Other

Registry information

Official study title

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

Important dates

Study start
2019
Primary completion
2020
Study completion
2020
First posted
May 24, 2021
Registry last updated
May 24, 2021

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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