Ignite Creation Date:
2025-12-24 @ 6:43 PM
Ignite Modification Date:
2026-01-02 @ 12:01 PM
Study NCT ID:
NCT02676557
Status:
COMPLETED
Last Update Posted:
2016-02-08
First Post:
2015-10-19
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
The Lamina Cribrosa (LC) Changes in the Eyes After Laser-Assisted in Situ Keratomileusis (LASIK)
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}}, 'protocolSection': {'designModule': {'studyType': 'OBSERVATIONAL', 'designInfo': {'timePerspective': 'PROSPECTIVE', 'observationalModel': 'COHORT'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 40}, 'targetDuration': '6 Months', 'patientRegistry': True}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '2014-04'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2016-02', 'completionDateStruct': {'date': '2015-03', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2016-02-05', 'studyFirstSubmitDate': '2015-10-19', 'studyFirstSubmitQcDate': '2016-02-05', 'lastUpdatePostDateStruct': {'date': '2016-02-08', 'type': 'ESTIMATED'}, 'studyFirstPostDateStruct': {'date': '2016-02-08', 'type': 'ESTIMATED'}, 'primaryCompletionDateStruct': {'date': '2014-08', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Change of lamina cribrosa (LC) depth', 'timeFrame': 'before the surgery, postoperative 1 day, 1 week, 1 month, and 3 months', 'description': 'micro millimeter'}, {'measure': 'Change of lamina cribrosa (LC) thickness', 'timeFrame': 'before the surgery, postoperative 1 day, 1 week, 1 month, and 3 months', 'description': 'micro millimeter'}, {'measure': 'Change of optic nerve head (ONH) width', 'timeFrame': 'before the surgery, postoperative 1 day, 1 week, 1 month, and 3 months', 'description': 'micro millimeter'}], 'secondaryOutcomes': [{'measure': 'Change of optic nerve head minimum rim width', 'timeFrame': 'before the surgery, postoperative 1 day, 1 week, 1 month, and 3 months', 'description': 'micro millimeter'}]}, 'oversightModule': {'oversightHasDmc': False}, 'conditionsModule': {'conditions': ['The Lamina Cribrosa and Optic Nerve Head Changes']}, 'descriptionModule': {'briefSummary': 'The burden of LASIK surgery on optic nerve head (ONH) has been controversial. Until now, the change of retinal nerve fiber layer (RNFL) thickness was used as the indicator of the study. In the present study, the investigators intended to investigate whether the changes of the deep and superficial structures around ONH exist or not using EDI OCT.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['CHILD', 'ADULT', 'OLDER_ADULT'], 'samplingMethod': 'NON_PROBABILITY_SAMPLE', 'studyPopulation': 'The myopic patients who were supposed to undergo LASIK surgery', 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* the myopic patients who were supposed to undergo LASIK surgery in the Samsung Medical Center\n\nExclusion Criteria:\n\n* Optic nerve head abnormalities at preoperative examination\n* Previous ocular surgical history'}, 'identificationModule': {'nctId': 'NCT02676557', 'briefTitle': 'The Lamina Cribrosa (LC) Changes in the Eyes After Laser-Assisted in Situ Keratomileusis (LASIK)', 'organization': {'class': 'OTHER', 'fullName': 'Samsung Medical Center'}, 'officialTitle': 'The Lamina Cribrosa (LC) Morphologic Changes in the Eyes After Laser-Assisted in Situ Keratomileusis (LASIK)', 'orgStudyIdInfo': {'id': 'LASIK-LC study'}}, 'armsInterventionsModule': {'armGroups': [{'label': 'LASIK', 'interventionNames': ['Device: Exposed to the high pressure during the surgery']}], 'interventions': [{'name': 'Exposed to the high pressure during the surgery', 'type': 'DEVICE', 'armGroupLabels': ['LASIK']}]}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Samsung Medical Center', 'class': 'OTHER'}, 'responsibleParty': {'type': 'PRINCIPAL_INVESTIGATOR', 'investigatorTitle': 'Professor', 'investigatorFullName': 'Changwon Kee', 'investigatorAffiliation': 'Samsung Medical Center'}}}}