Ignite Creation Date:
2025-12-24 @ 4:56 PM
Ignite Modification Date:
2026-01-01 @ 9:59 AM
Study NCT ID:
NCT04671550
Status:
UNKNOWN
Last Update Posted:
2021-09-28
First Post:
2020-11-29
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
The Value of Visual Field Examination in Driving Licence.
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'conditionBrowseModule': {'meshes': [{'id': 'D005901', 'term': 'Glaucoma'}], 'ancestors': [{'id': 'D009798', 'term': 'Ocular Hypertension'}, {'id': 'D005128', 'term': 'Eye Diseases'}]}, 'interventionBrowseModule': {'meshes': [{'id': 'D010147', 'term': 'Pain Measurement'}], 'ancestors': [{'id': 'D009460', 'term': 'Neurologic Examination'}, {'id': 'D010808', 'term': 'Physical Examination'}, {'id': 'D019937', 'term': 'Diagnostic Techniques and Procedures'}, {'id': 'D003933', 'term': 'Diagnosis'}]}}, 'protocolSection': {'designModule': {'studyType': 'OBSERVATIONAL', 'designInfo': {'timePerspective': 'CROSS_SECTIONAL', 'observationalModel': 'CASE_ONLY'}, 'enrollmentInfo': {'type': 'ESTIMATED', 'count': 200}, 'patientRegistry': False}, 'statusModule': {'overallStatus': 'UNKNOWN', 'lastKnownStatus': 'RECRUITING', 'startDateStruct': {'date': '2020-11-01', 'type': 'ACTUAL'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2021-09', 'completionDateStruct': {'date': '2021-12', 'type': 'ESTIMATED'}, 'lastUpdateSubmitDate': '2021-09-27', 'studyFirstSubmitDate': '2020-11-29', 'studyFirstSubmitQcDate': '2020-12-15', 'lastUpdatePostDateStruct': {'date': '2021-09-28', 'type': 'ACTUAL'}, 'studyFirstPostDateStruct': {'date': '2020-12-17', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2021-10', 'type': 'ESTIMATED'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Evaluation of Visual Field quality by combining two parameters obtained by Computerized Visual Field Examination: number of missed points within the central 20° visual field and average Sensitivity (AS) of all the 60 points of the 24-2 grid', 'timeFrame': 'Baseline', 'description': 'The Visual Field quality will be evaluated by considering two variables: Number of missed points within the central 20° visual field (expressed in number) and average Sensitivity (AS) of all the 60 points of the 24-2 grid (expressed in decibel, dB)'}], 'secondaryOutcomes': [{'measure': 'Creation of a Integrated Visual Field of both eyes', 'timeFrame': 'Baseline', 'description': 'Composition of the Visual Fields of both eyes of the same subject obtained by the Cmputerized Visual Field by integrating average sensitivity expressed in decibel (dB) and the missed points expressed in pure numbers.'}]}, 'oversightModule': {'oversightHasDmc': False, 'isFdaRegulatedDrug': False, 'isFdaRegulatedDevice': False}, 'conditionsModule': {'keywords': ['visual field', 'driving licence', 'glaucoma'], 'conditions': ['Glaucoma Eye']}, 'descriptionModule': {'briefSummary': "The aim of the study is to identify clinical criteria, easily achievable with patient's follow-up tests, which can identify individuals at increased risk of being unfit to drive. Only they, then, will be directed to further investigations. These clinical standards should also be suitable for implementing or substituting the current law's criteria, after appropriate additional studies, so that the law can be based on the clinic.", 'detailedDescription': "In this observational study, the investigators recruite patients referred at the Glaucoma Service of the Ophthalmologic Clinic of the ASST Sette Laghi University Hospital in Varese.\n\nAll the patients enrolled in the study require a reliable (less than 15% of false positive or false negative and no more than 33% of loss of fixation) visual field examination (Humphrey SITA 24-2 or 30-2 SITA Standard) performed in the previous six months.\n\nAll patients undergo a full ophthalmologic examination and verbally submitted a questionnaire designed by the authors of the paper (LL, SD, MD).\n\nThe examination included Visual Acuity, refraction, slit lamp bio-microscospy, Goldmann's applanation tonometry, gonioscopy with four mirror lens, OCT RNFL and GCL imaging if necessary and re-evaluation of target IOP.\n\nThe investigators use the two monocular visual fields to build an Integrated Visual Field which, according to D.P. Crabb papers, is an efficient surrogate to the Binocular Esterman Visual Field Test (EVFT). In short, each point in each monocular field is compared to its equivalent in the other eye, and the data, from the eye with the best sensitivity, are used. Locations are dichotomized into groups with sensitivity \\> 10 dB and \\< 10 dB, representing whether a patient would see or miss a point in the Esterman test, respectively. To match even better the IVF with the EVFT, 8 points of the inner 20° of the IVF were excluded since they have no direct equivalent in the EVFT."}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'minimumAge': '18 Years', 'samplingMethod': 'NON_PROBABILITY_SAMPLE', 'studyPopulation': 'The investigators recruite patients referred at the Glaucoma Service of the Ophthalmologic Clinic of the ASST Sette Laghi University Hospital in Varese', 'eligibilityCriteria': 'Inclusion Criteria:\n\n* subjects above 18 years of age\n* clear diagnosis of Glaucoma (of any type)\n* to show a reliable (less than 15% of false positive or false negative and no more than 33% of loss of fixation) visual field examination (Humphrey SITA 24-2 or 30-2 SITA Standard) performed in the previous six months.\n\nExclusion Criteria:\n\n* other ocular conditions that could affect the visual field (i.e. cataract or macular degeneration).\n* patients that underwent a 10-2 test since it does not allow the composition of the Integrated Visual Field.'}, 'identificationModule': {'nctId': 'NCT04671550', 'briefTitle': 'The Value of Visual Field Examination in Driving Licence.', 'organization': {'class': 'OTHER', 'fullName': "Università degli Studi dell'Insubria"}, 'officialTitle': 'Glaucoma and Driving Licence: How to Identify Patients at Risk of Having it Revoked', 'orgStudyIdInfo': {'id': '2020/Glaucoma'}}, 'armsInterventionsModule': {'interventions': [{'name': 'questionnaire', 'type': 'DIAGNOSTIC_TEST', 'description': 'Questionnaire on "Driving performances and Visual Field"'}]}, 'contactsLocationsModule': {'locations': [{'zip': '21100', 'city': 'Varese', 'status': 'RECRUITING', 'country': 'Italy', 'contacts': [{'name': 'Simone Donati, MD', 'role': 'CONTACT', 'email': 'simone.donati@uninsubria.it', 'phone': '00393333615015'}], 'facility': 'ASST Sette Laghi', 'geoPoint': {'lat': 45.82058, 'lon': 8.82511}}]}, 'ipdSharingStatementModule': {'ipdSharing': 'UNDECIDED'}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': "Università degli Studi dell'Insubria", 'class': 'OTHER'}, 'responsibleParty': {'type': 'PRINCIPAL_INVESTIGATOR', 'investigatorTitle': 'Associate Professor', 'investigatorFullName': 'Simone Donati', 'investigatorAffiliation': "Università degli Studi dell'Insubria"}}}}