Ignite Creation Date:
2025-12-26 @ 11:00 AM
Ignite Modification Date:
2026-03-02 @ 6:08 AM
Study NCT ID:
NCT03076606
Status:
TERMINATED
Last Update Posted:
2023-09-15
First Post:
2017-03-06
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Nurses Ability to Assess Visual Acuity in Geriatric Consultation
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': 15}, 'patientRegistry': False}, 'statusModule': {'whyStopped': 'recruiting issues and unavailable ophtalmologists', 'overallStatus': 'TERMINATED', 'startDateStruct': {'date': '2017-03-20', 'type': 'ACTUAL'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2020-01', 'completionDateStruct': {'date': '2020-05-04', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2023-09-13', 'studyFirstSubmitDate': '2017-03-06', 'studyFirstSubmitQcDate': '2017-03-09', 'lastUpdatePostDateStruct': {'date': '2023-09-15', 'type': 'ACTUAL'}, 'studyFirstPostDateStruct': {'date': '2017-03-10', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2020-05-04', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'visual acuity values concordance between nurses and ophthalmologist', 'timeFrame': 'day 1', 'description': 'On 2 (near and far) binocular values per patient with their usual glasses. Concordance is assessed on the assignment of patients to one of the 3 groups: ≤ 5 / 10e, 6-7 / 10 e, ≥ 8/10 e'}], 'secondaryOutcomes': [{'measure': 'new diagnosis or ophthalmologic pathology aggravation', 'timeFrame': 'day 1', 'description': 'Percentage of patients in whom new diagnosis or ophthalmologic pathology aggravation was identified'}, {'measure': 'cognitive influence', 'timeFrame': 'day 1', 'description': 'Compare the binocular visual acuity values agreement in each subgroup: with MMSE \\<18/30 and with MMSE ≥18/30'}]}, 'oversightModule': {'oversightHasDmc': False, 'isFdaRegulatedDrug': False, 'isFdaRegulatedDevice': False}, 'conditionsModule': {'conditions': ['Visual Acuity', 'Accidental Fall', 'Aging', "Nurse's Role"]}, 'descriptionModule': {'briefSummary': 'Nurses participate to geriatric evaluations for falling patients. For these patients, it is recommended to evaluate,especially, visual acuity but this is not currently done because it is difficult to systematically combine with an ophthalmologic consultation.\n\nThe HAS french recommendations propose to detect visual acuity deficiency using Monoyer and Parinaud scales, without specifying the professional qualification. According to the nurse competence decree of State Graduates, "sensory disorders" screening is a "non-vulnerable" examination, and can be performed by nurses. Therefore, they can use these scales, after training.\n\nWe propose to evaluate the correlation between visual acuity scores obtained by nurses in geriatric consultations and an ophthalmologist.\n\nThis study should include 204 patients over 65 years, who have fallen at least twice in the last 12 months. These patients will benefit from an evaluation by an ophthalmologist, after the geriatric consultation.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['OLDER_ADULT'], 'minimumAge': '65 Years', 'samplingMethod': 'NON_PROBABILITY_SAMPLE', 'studyPopulation': 'Patients aged 65 and over referred for Visual Acuity evaluation', 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* at least 2 falls in the last 12 months,\n* applied in geriatric evaluation\n* talking French\n* affiliated to the social security system\n\nExclusion Criteria:\n\n* not communicating\n* illiterate\n* Total blindness'}, 'identificationModule': {'nctId': 'NCT03076606', 'acronym': 'AVIGE', 'briefTitle': 'Nurses Ability to Assess Visual Acuity in Geriatric Consultation', 'organization': {'class': 'OTHER', 'fullName': 'University Hospital, Caen'}, 'officialTitle': 'Nurses Ability to Assess Visual Acuity in Geriatric Consultation', 'orgStudyIdInfo': {'id': 'AVIGE 16-114'}}, 'armsInterventionsModule': {'interventions': [{'name': 'ophthalmologist examination', 'type': 'DIAGNOSTIC_TEST', 'description': 'ophthalmologist examination after geriatric consultation'}]}, 'contactsLocationsModule': {'locations': [{'zip': '14033', 'city': 'Caen', 'country': 'France', 'facility': 'Caen University Hospital', 'geoPoint': {'lat': 49.18585, 'lon': -0.35912}}]}, 'ipdSharingStatementModule': {'ipdSharing': 'NO'}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'University Hospital, Caen', 'class': 'OTHER'}, 'responsibleParty': {'type': 'SPONSOR'}}}}