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
1 other identifier
interventional
30
1 country
1
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.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at below P25 for not_applicable
Started Dec 2019
Shorter than P25 for not_applicable
1 active site
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
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Study Timeline
Key milestones and dates
Study Start
First participant enrolled
December 12, 2019
CompletedPrimary Completion
Last participant's last visit for primary outcome
March 14, 2020
CompletedStudy Completion
Last participant's last visit for all outcomes
July 15, 2020
CompletedFirst Submitted
Initial submission to the registry
May 10, 2021
CompletedFirst Posted
Study publicly available on registry
May 24, 2021
CompletedMay 24, 2021
May 1, 2021
3 months
May 10, 2021
May 19, 2021
Conditions
Keywords
Outcome Measures
Primary Outcomes (1)
Change of Flare 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 Outcomes (1)
Change of Corneal endothelium features-1
the changes of the parameters of preoperative and 3. months' values
Other Outcomes (2)
Change of Corneal endothelium features-2
the changes of the parameters of preoperative and 3. months' values
Change of Corneal endothelium features-3
the changes of the parameters of preoperative and 3. months' values
Study Arms (1)
Pre-surgery and post-surgery
OTHERfemtosecond assisted LASIK
Interventions
Eligibility Criteria
You may qualify if:
- The patients who performed Femtosecond laser assisted LASIK for myopia or myopic astigmatism.
- Uncomplicated surgery
You may not qualify if:
- Complicated surgery,
- Hyperopic or hyperopic astigmatism
- Lack of follow-up measurements
Contact the study team to confirm eligibility.
Sponsors & Collaborators
Study Sites (1)
Istanbul Faculty of Medicine
Fatih, Istanbul, Turkey (Türkiye)
Related Publications (1)
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.
PMID: 34868671DERIVED
MeSH Terms
Conditions
Condition Hierarchy (Ancestors)
Study Officials
- PRINCIPAL INVESTIGATOR
Kemal Turgay Ozbilen, M.D.
Istanbul University
Study Design
- Study Type
- interventional
- Phase
- not applicable
- Allocation
- NA
- Masking
- NONE
- Masking Details
- Patients name and identifiers were masked
- Purpose
- PREVENTION
- Intervention Model
- SINGLE GROUP
- Sponsor Type
- OTHER
- Responsible Party
- PRINCIPAL INVESTIGATOR
- PI Title
- M.D. Academics
Study Record Dates
First Submitted
May 10, 2021
First Posted
May 24, 2021
Study Start
December 12, 2019
Primary Completion
March 14, 2020
Study Completion
July 15, 2020
Last Updated
May 24, 2021
Record last verified: 2021-05