Ignite Creation Date:
2025-12-25 @ 12:03 AM
Ignite Modification Date:
2026-01-27 @ 5:05 PM
Study NCT ID:
NCT04899258
Status:
COMPLETED
Last Update Posted:
2021-05-24
First Post:
2021-05-10
Is NOT Gene Therapy:
True
Has Adverse Events:
False
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
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'conditionBrowseModule': {'meshes': [{'id': 'D003316', 'term': 'Corneal Diseases'}], 'ancestors': [{'id': 'D005128', 'term': 'Eye Diseases'}]}}, 'protocolSection': {'designModule': {'phases': ['NA'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'NA', 'maskingInfo': {'masking': 'NONE', 'maskingDescription': 'Patients name and identifiers were masked'}, 'primaryPurpose': 'PREVENTION', 'interventionModel': 'SINGLE_GROUP', 'interventionModelDescription': 'prospective, before-after study'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 30}}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '2019-12-12', 'type': 'ACTUAL'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2021-05', 'completionDateStruct': {'date': '2020-07-15', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2021-05-19', 'studyFirstSubmitDate': '2021-05-10', 'studyFirstSubmitQcDate': '2021-05-19', 'lastUpdatePostDateStruct': {'date': '2021-05-24', 'type': 'ACTUAL'}, 'studyFirstPostDateStruct': {'date': '2021-05-24', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2020-03-14', 'type': 'ACTUAL'}}, 'outcomesModule': {'otherOutcomes': [{'measure': 'Change of Corneal endothelium features-2', 'timeFrame': "the changes of the parameters of preoperative and 3. months' values", 'description': 'Coefficient of Varience (CV) in cell size, (The parameter was measured by specular microscopy)'}, {'measure': 'Change of Corneal endothelium features-3', 'timeFrame': "the changes of the parameters of preoperative and 3. months' values", 'description': 'Hexagonality percent of the cell shape. (The parameter was measured by specular microscopy)'}], 'primaryOutcomes': [{'measure': 'Change of Flare Values', 'timeFrame': 'The change of flare values on first day, seventh day, 1. month and 3. months according to preoperative values', 'description': 'To measure anterior chamber inflammation objectively, Flare values were measured by the laser flare-photometry'}], 'secondaryOutcomes': [{'measure': 'Change of Corneal endothelium features-1', 'timeFrame': "the changes of the parameters of preoperative and 3. months' values", 'description': 'Endothelial cell density (ECD),(The parameter was measured by specular microscopy)'}]}, 'oversightModule': {'oversightHasDmc': True, 'isFdaRegulatedDrug': False, 'isFdaRegulatedDevice': False}, 'conditionsModule': {'keywords': ['Excimer laser Corneal Endothelium', 'Laser in situ keratomileusis (LASIK);', 'femtosecond assisted-LASIK', 'Anterior chamber flare', 'Endothelial cell densit', 'Corneal Endothelium'], 'conditions': ['Cornea', 'Refractive Surgery', 'Anterior Chamber Inflammation']}, 'referencesModule': {'references': [{'pmid': '34868671', 'type': 'DERIVED', '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.'}]}, 'descriptionModule': {'briefSummary': '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.', 'detailedDescription': '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.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT'], 'maximumAge': '50 Years', 'minimumAge': '18 Years', 'healthyVolunteers': True, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* The patients who performed Femtosecond laser assisted LASIK for myopia or myopic astigmatism.\n* Uncomplicated surgery\n\nExclusion Criteria:\n\n* Complicated surgery,\n* Hyperopic or hyperopic astigmatism\n* Lack of follow-up measurements'}, 'identificationModule': {'nctId': 'NCT04899258', 'briefTitle': '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', 'organization': {'class': 'OTHER', 'fullName': 'Istanbul University'}, 'officialTitle': 'Effect of Myopic Femtosecond Laser Asssisted-LASIK on Anaterior Chamber Flare Values and Corneal Endothelial Cells', 'orgStudyIdInfo': {'id': '06.12.2019/20/1495'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'OTHER', 'label': 'Pre-surgery and post-surgery', 'description': 'femtosecond assisted LASIK', 'interventionNames': ['Procedure: Femtosecond laser assisted LASIK']}], 'interventions': [{'name': 'Femtosecond laser assisted LASIK', 'type': 'PROCEDURE', 'description': 'Refractive surgery', 'armGroupLabels': ['Pre-surgery and post-surgery']}]}, 'contactsLocationsModule': {'locations': [{'city': 'Fatih', 'state': 'Istanbul', 'country': 'Turkey (Türkiye)', 'facility': 'Istanbul Faculty of Medicine', 'geoPoint': {'lat': 41.0225, 'lon': 28.94083}}], 'overallOfficials': [{'name': 'Kemal Turgay Ozbilen, M.D.', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': 'Istanbul University'}]}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Istanbul University', 'class': 'OTHER'}, 'responsibleParty': {'type': 'PRINCIPAL_INVESTIGATOR', 'investigatorTitle': 'M.D. Academics', 'investigatorFullName': 'Kemal Turgay Ozbilen', 'investigatorAffiliation': 'Istanbul University'}}}}