Back to resultsEvaluation of the Effect of Myopic Femtosecond Laser Assisted-LASIK on Anterior Chamber Flare Values and Corneal Endothelial Cells: A Prospective Before-and-After Study
Primary Purpose
Cornea, Refractive Surgery, Anterior Chamber Inflammation
Status
Completed
Phase
Not Applicable
Locations
Turkey
Study Type
Interventional
Intervention
Femtosecond laser assisted LASIK
Sponsored by
About this trial
This is an interventional prevention trial for Cornea focused on measuring Excimer laser Corneal Endothelium, Laser in situ keratomileusis (LASIK);, femtosecond assisted-LASIK, Anterior chamber flare, Endothelial cell densit, Corneal Endothelium
Eligibility Criteria
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
Sites / Locations
- Istanbul Faculty of Medicine
Arms of the Study
Arm 1
Arm Type
Other
Arm Label
Pre-surgery and post-surgery
Arm Description
femtosecond assisted LASIK
Outcomes
Primary Outcome Measures
Change of Flare Values
To measure anterior chamber inflammation objectively, Flare values were measured by the laser flare-photometry
Secondary Outcome Measures
Change of Corneal endothelium features-1
Endothelial cell density (ECD),(The parameter was measured by specular microscopy)
Full Information
1. Study Identification
Unique Protocol Identification Number
NCT04899258
Brief Title
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
Official Title
Effect of Myopic Femtosecond Laser Asssisted-LASIK on Anaterior Chamber Flare Values and Corneal Endothelial Cells
Study Type
Interventional
2. Study Status
Record Verification Date
May 2021
Overall Recruitment Status
Completed
Study Start Date
December 12, 2019 (Actual)
Primary Completion Date
March 14, 2020 (Actual)
Study Completion Date
July 15, 2020 (Actual)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
Istanbul University
4. Oversight
Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
Yes
5. Study Description
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.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Cornea, Refractive Surgery, Anterior Chamber Inflammation
Keywords
Excimer laser Corneal Endothelium, Laser in situ keratomileusis (LASIK);, femtosecond assisted-LASIK, Anterior chamber flare, Endothelial cell densit, Corneal Endothelium
7. Study Design
Primary Purpose
Prevention
Study Phase
Not Applicable
Interventional Study Model
Single Group Assignment
Model Description
prospective, before-after study
Masking
None (Open Label)
Masking Description
Patients name and identifiers were masked
Allocation
N/A
Enrollment
30 (Actual)
8. Arms, Groups, and Interventions
Arm Title
Pre-surgery and post-surgery
Arm Type
Other
Arm Description
femtosecond assisted LASIK
Intervention Type
Procedure
Intervention Name(s)
Femtosecond laser assisted LASIK
Intervention Description
Refractive surgery
Primary Outcome Measure Information:
Title
Change of Flare Values
Description
To measure anterior chamber inflammation objectively, Flare values were measured by the laser flare-photometry
Time Frame
The change of flare values on first day, seventh day, 1. month and 3. months according to preoperative values
Secondary Outcome Measure Information:
Title
Change of Corneal endothelium features-1
Description
Endothelial cell density (ECD),(The parameter was measured by specular microscopy)
Time Frame
the changes of the parameters of preoperative and 3. months' values
Other Pre-specified Outcome Measures:
Title
Change of Corneal endothelium features-2
Description
Coefficient of Varience (CV) in cell size, (The parameter was measured by specular microscopy)
Time Frame
the changes of the parameters of preoperative and 3. months' values
Title
Change of Corneal endothelium features-3
Description
Hexagonality percent of the cell shape. (The parameter was measured by specular microscopy)
Time Frame
the changes of the parameters of preoperative and 3. months' values
10. Eligibility
Sex
All
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
50 Years
Accepts Healthy Volunteers
Accepts Healthy Volunteers
Eligibility Criteria
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
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Kemal Turgay Ozbilen, M.D.
Organizational Affiliation
Istanbul University
Official's Role
Principal Investigator
Facility Information:
Facility Name
Istanbul Faculty of Medicine
City
Fatih
State/Province
Istanbul
Country
Turkey
12. IPD Sharing Statement
Citations:
PubMed Identifier
34868671
Citation
Ozbilen KT, Altinkurt E, Ceylan NA, Bilgin GS, Gozum N. Effect of Myopic Femtosecond Laser-Assisted LASIK on Anterior Chamber Inflammation (Flare Values) and Corneal Endothelium: A Prospective before and after Study. J Ophthalmol. 2021 Nov 26;2021:2395028. doi: 10.1155/2021/2395028. eCollection 2021.
Results Reference
derived
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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
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