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

• Sponsor: Istanbul University (Other)
• Overall Status: Completed
• CT.gov ID: NCT04899258
• Collaborator: (none)
• Enrollment: 30
• Location: 1
• Arm: 1
• Actual Duration (Months): 7.1
• Patients Per Site Per Month: 4.2

Study Details

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.

Condition or Disease	Intervention/Treatment	Phase
Cornea; Refractive Surgery; Anterior Chamber Inflammation	Procedure: Femtosecond laser assisted LASIK	N/A

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 Design

• Study Type: Interventional
• Actual Enrollment: 30 participants
• Allocation: N/A
• Intervention Model: Single Group Assignment
• Intervention Model Description: prospective, before-after studyprospective, before-after study
• Masking: None (Open Label)
• Masking Description: Patients name and identifiers were masked
• Primary Purpose: Prevention
• Official Title: Effect of Myopic Femtosecond Laser Asssisted-LASIK on Anaterior Chamber Flare Values and Corneal Endothelial Cells
• Actual Study Start Date: Dec 12, 2019
• Actual Primary Completion Date: Mar 14, 2020
• Actual Study Completion Date: Jul 15, 2020

Arms and Interventions

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

Outcome Measures

Primary Outcome Measures

1. Change of Flare Values [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 Outcome Measures

1. Change of Corneal endothelium features-1 [the changes of the parameters of preoperative and 3. months' values]

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

Other Outcome Measures

1. Change of Corneal endothelium features-2 [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 [the changes of the parameters of preoperative and 3. months' values]

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

Eligibility Criteria

Criteria

• Ages Eligible for Study: 18 Years to 50 Years
• Sexes Eligible for Study: All
• Accepts Healthy Volunteers: Yes

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

Contacts and Locations

Locations

	Site	City	State	Country	Postal Code
1	Istanbul Faculty of Medicine	Fatih	Istanbul	Turkey

Sponsors and Collaborators

• Istanbul University

Investigators

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

Study Documents (Full-Text)

None provided.

More Information

Publications

None provided.

• Responsible Party: Kemal Turgay Ozbilen, M.D. Academics, Istanbul University
• ClinicalTrials.gov Identifier: NCT04899258
• Other Study ID Numbers: 06.12.2019/20/1495
• First Posted: May 24, 2021
• Last Update Posted: May 24, 2021
• Last Verified: May 1, 2021

• Studies a U.S. FDA-regulated Drug Product: No
• Studies a U.S. FDA-regulated Device Product: No
• Keywords provided by Kemal Turgay Ozbilen, M.D. Academics, Istanbul University: Excimer laser Corneal Endothelium; Laser in situ keratomileusis (LASIK);; femtosecond assisted-LASIK; Anterior chamber flare; Endothelial cell densit; Corneal Endothelium
• Additional relevant MeSH terms: Inflammation

Study Results

No Results Posted as of May 24, 2021