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

May 19, 2021 updated by: Kemal Turgay Ozbilen, Istanbul University

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

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.

Study Overview

Status

Completed

Conditions

Intervention / Treatment

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 Type

Interventional

Enrollment (Actual)

30

Phase

  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • Turkey
    • Istanbul
      • Fatih, Istanbul, Turkey
        • Istanbul Faculty of Medicine

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years to 50 years (Adult)

Accepts Healthy Volunteers

Yes

Genders Eligible for Study

All

Description

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 Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Prevention
  • Allocation: N/A
  • Interventional Model: Single Group Assignment
  • Masking: None (Open Label)

Arms and Interventions

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

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
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
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
Time Frame: the changes of the parameters of preoperative and 3. months' values
Endothelial cell density (ECD),(The parameter was measured by specular microscopy)
the changes of the parameters of preoperative and 3. months' values

Other Outcome Measures

Outcome Measure
Measure Description
Time Frame
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)
the changes of the parameters of preoperative and 3. months' values
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)
the changes of the parameters of preoperative and 3. months' values

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Istanbul University

Investigators

  • Principal Investigator: Kemal Turgay Ozbilen, M.D., Istanbul University

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

December 12, 2019

Primary Completion (Actual)

March 14, 2020

Study Completion (Actual)

July 15, 2020

Study Registration Dates

First Submitted

May 10, 2021

First Submitted That Met QC Criteria

May 19, 2021

First Posted (Actual)

May 24, 2021

Study Record Updates

Last Update Posted (Actual)

May 24, 2021

Last Update Submitted That Met QC Criteria

May 19, 2021

Last Verified

May 1, 2021

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • 06.12.2019/20/1495

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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