Ignite Creation Date:
2025-12-25 @ 3:26 AM
Ignite Modification Date:
2026-02-27 @ 11:19 AM
Study NCT ID:
NCT03097705
Status:
UNKNOWN
Last Update Posted:
2017-03-31
First Post:
2017-03-08
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Effect of Steep Trendelenburg in Laparoscopic Surgery on IOP & RNFL Thickness
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'interventionBrowseModule': {'meshes': [{'id': 'D041623', 'term': 'Tomography, Optical Coherence'}], 'ancestors': [{'id': 'D041622', 'term': 'Tomography, Optical'}, {'id': 'D061848', 'term': 'Optical Imaging'}, {'id': 'D003952', 'term': 'Diagnostic Imaging'}, {'id': 'D019937', 'term': 'Diagnostic Techniques and Procedures'}, {'id': 'D003933', 'term': 'Diagnosis'}, {'id': 'D014054', 'term': 'Tomography'}, {'id': 'D008919', 'term': 'Investigative Techniques'}]}}, 'protocolSection': {'designModule': {'phases': ['NA'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'NA', 'maskingInfo': {'masking': 'NONE'}, 'primaryPurpose': 'DIAGNOSTIC', 'interventionModel': 'SINGLE_GROUP'}, 'enrollmentInfo': {'type': 'ESTIMATED', 'count': 50}}, 'statusModule': {'overallStatus': 'UNKNOWN', 'lastKnownStatus': 'NOT_YET_RECRUITING', 'startDateStruct': {'date': '2017-04-20', 'type': 'ESTIMATED'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2017-03', 'completionDateStruct': {'date': '2018-03-12', 'type': 'ESTIMATED'}, 'lastUpdateSubmitDate': '2017-03-26', 'studyFirstSubmitDate': '2017-03-08', 'studyFirstSubmitQcDate': '2017-03-26', 'lastUpdatePostDateStruct': {'date': '2017-03-31', 'type': 'ACTUAL'}, 'studyFirstPostDateStruct': {'date': '2017-03-31', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2017-09-12', 'type': 'ESTIMATED'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Intra Ocular Pressure (IOP)', 'timeFrame': 'Change in IOP from baseline to IOP during surgery and to one week and to three months following surgery', 'description': 'IOP measurement will be taken before, during and after surgery using ICARE tonometer'}, {'measure': 'Retinal Nerve Fiber Layer Thickness (RNFL) using OCT', 'timeFrame': 'Change in OCT RNFL thickness from baseline to OCT RNFL thickness during surgery and to one week and to three months following surgery', 'description': 'RNFL measurement will be taken before and after surgery using spectralis OCT'}]}, 'oversightModule': {'oversightHasDmc': True, 'isFdaRegulatedDrug': False, 'isFdaRegulatedDevice': False}, 'conditionsModule': {'conditions': ['Intraocular Pressure', 'Retinal Nerve Fiber Bundle Deficiency']}, 'descriptionModule': {'briefSummary': 'The effect of Steep Trendelenburg position used during laparoscopic surgery on intraocular pressure during surgery and on the retinal nerve fiber thickness after surgery', 'detailedDescription': 'To measure IOP and RNFL thickness in subjects undergoing laparoscopic operations in steep trendelenburg before, during, and after the operation'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'maximumAge': '120 Years', 'minimumAge': '40 Years', 'healthyVolunteers': True, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* SUBJECTS INTENDING TO UNDERGO LAPROSCOPIC SERGURY WHICH HAVE NO EYE DISEASES\n\nExclusion Criteria:\n\n* SUBJECT WITH EYES DISEASE\n* PREGNANCY DURING THE STUDY PERIOD'}, 'identificationModule': {'nctId': 'NCT03097705', 'briefTitle': 'Effect of Steep Trendelenburg in Laparoscopic Surgery on IOP & RNFL Thickness', 'organization': {'class': 'OTHER', 'fullName': 'Carmel Medical Center'}, 'officialTitle': 'The Effect of Steep Trendelenburg Position Used During Laparoscopic Surgery on Intraocular Pressure During Surgery and on the Retinal Nerve Fiber Thickness After Surgery', 'orgStudyIdInfo': {'id': 'CMC-17-0026-CTIL'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'OTHER', 'label': 'IOP and OCT RNFL measurements', 'description': 'all subjects will undergo ophthalmological exams including IOP and RNFL OCT measurements', 'interventionNames': ['Diagnostic Test: OCT (Optical coherence tomography)']}], 'interventions': [{'name': 'OCT (Optical coherence tomography)', 'type': 'DIAGNOSTIC_TEST', 'otherNames': ['CARE (ICARE FINLAND Oy)'], 'description': 'RNFL AND IOP MEASUREMNTS', 'armGroupLabels': ['IOP and OCT RNFL measurements']}]}, 'ipdSharingStatementModule': {'ipdSharing': 'NO'}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Carmel Medical Center', 'class': 'OTHER'}, 'responsibleParty': {'type': 'PRINCIPAL_INVESTIGATOR', 'investigatorTitle': 'PROFESSOR', 'investigatorFullName': 'Orna Geyer', 'investigatorAffiliation': 'Carmel Medical Center'}}}}