Ignite Creation Date:
2025-12-24 @ 11:14 PM
Ignite Modification Date:
2025-12-26 @ 5:00 AM
Study NCT ID:
NCT00804869
Status:
WITHDRAWN
Last Update Posted:
2024-05-30
First Post:
2008-12-03
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
A-mode vs PalmScan Ultrasonography: Biometric Measurements.
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}}, 'protocolSection': {'designModule': {'studyType': 'OBSERVATIONAL', 'designInfo': {'timePerspective': 'RETROSPECTIVE', 'observationalModel': 'COHORT'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 0}}, 'statusModule': {'whyStopped': 'Undefined', 'overallStatus': 'WITHDRAWN', 'startDateStruct': {'date': '2008-10', 'type': 'ACTUAL'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2024-05', 'completionDateStruct': {'date': '2008-12', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2024-05-29', 'studyFirstSubmitDate': '2008-12-03', 'studyFirstSubmitQcDate': '2008-12-06', 'lastUpdatePostDateStruct': {'date': '2024-05-30', 'type': 'ACTUAL'}, 'studyFirstPostDateStruct': {'date': '2008-12-09', 'type': 'ESTIMATED'}, 'primaryCompletionDateStruct': {'date': '2008-12', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'axial length (AL).', 'timeFrame': 'during examination'}, {'measure': 'Anterior Chamber Deep (ACD)', 'timeFrame': 'during examination'}, {'measure': 'Lens Thickness (LT)', 'timeFrame': 'during examination'}]}, 'oversightModule': {'oversightHasDmc': True}, 'conditionsModule': {'conditions': ['Axial Length (AL)', 'Anterior Chamber Deep (ACD)', 'Lens Thickness (LT)']}, 'descriptionModule': {'briefSummary': 'Ultrasonography has become a critical ancillary test in the clinical practice of ophthalmology. It is commonly used as a standardized method for assessing intraocular biometry. The PalmScan ultrasonography (PsU) is a portable A-scan device that uses the same principles as the standard A-scan. The aim of the study is to compare the reliability of their measurements, in order to use them indistinctively.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'maximumAge': '90 Years', 'minimumAge': '50 Years', 'samplingMethod': 'PROBABILITY_SAMPLE', 'studyPopulation': 'All patients who need axial length calculation.', 'healthyVolunteers': True, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* Patients with indication for a standard A-mode ultrasound\n\nExclusion Criteria:\n\n* No superficial anormalities.\n* Patients with external injuries.\n* Intraocular silicon oil.\n* Retinal detachment\n* Significant ocular pathologies.'}, 'identificationModule': {'nctId': 'NCT00804869', 'briefTitle': 'A-mode vs PalmScan Ultrasonography: Biometric Measurements.', 'organization': {'class': 'OTHER', 'fullName': 'Asociación para Evitar la Ceguera en México'}, 'officialTitle': 'Standard A-mode Ultrasonography vs PalmScan Ultrasonography: Biometric Measurements.', 'orgStudyIdInfo': {'id': 'APEC-037'}}, 'armsInterventionsModule': {'armGroups': [{'label': '1', 'description': 'PalmScan biometric group', 'interventionNames': ['Device: PalmScan A2000 ultrasonography system (Micro Medical Devices, Calabasas, CA)']}, {'label': '2', 'description': 'A-mode ultrasonography biometric group', 'interventionNames': ['Device: Standard A-mode ultrasound (Eye Cubed™, Ellex, Adelaide, Australia).']}], 'interventions': [{'name': 'PalmScan A2000 ultrasonography system (Micro Medical Devices, Calabasas, CA)', 'type': 'DEVICE', 'description': 'PalmScan biometric measurements', 'armGroupLabels': ['1']}, {'name': 'Standard A-mode ultrasound (Eye Cubed™, Ellex, Adelaide, Australia).', 'type': 'DEVICE', 'description': 'A-mode biometric measurements group', 'armGroupLabels': ['2']}]}, 'contactsLocationsModule': {'locations': [{'zip': '04030', 'city': 'Mexico City', 'state': 'Mexico City', 'country': 'Mexico', 'facility': 'Asociación para Evitar la Ceguera en México', 'geoPoint': {'lat': 19.42847, 'lon': -99.12766}}]}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Asociación para Evitar la Ceguera en México', 'class': 'OTHER'}, 'responsibleParty': {'type': 'SPONSOR'}}}}