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

NCT ID: NCT04899258

Last Updated: 2021-05-24

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

NA

Total Enrollment

30 participants

Study Classification

INTERVENTIONAL

Study Start Date

2019-12-12

Study Completion Date

2020-07-15

Brief Summary

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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

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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.

Conditions

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Cornea Refractive Surgery Anterior Chamber Inflammation

Study Design

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Allocation Method

NA

Intervention Model

SINGLE_GROUP

prospective, before-after study
Primary Study Purpose

PREVENTION

Blinding Strategy

NONE

Patients name and identifiers were masked

Study Groups

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Pre-surgery and post-surgery

femtosecond assisted LASIK

Group Type OTHER

Femtosecond laser assisted LASIK

Intervention Type PROCEDURE

Refractive surgery

Interventions

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Femtosecond laser assisted LASIK

Refractive surgery

Intervention Type PROCEDURE

Eligibility Criteria

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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
Minimum Eligible Age

18 Years

Maximum Eligible Age

50 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

Yes

Sponsors

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Istanbul University

OTHER

Sponsor Role lead

Responsible Party

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Kemal Turgay Ozbilen

M.D. Academics

Responsibility Role PRINCIPAL_INVESTIGATOR

Principal Investigators

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Kemal Turgay Ozbilen, M.D.

Role: PRINCIPAL_INVESTIGATOR

Istanbul University

Locations

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Istanbul Faculty of Medicine

Fatih, Istanbul, Turkey (Türkiye)

Site Status

Countries

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Turkey (Türkiye)

References

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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.

Reference Type DERIVED
PMID: 34868671 (View on PubMed)

Other Identifiers

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06.12.2019/20/1495

Identifier Type: -

Identifier Source: org_study_id

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