Ignite Creation Date:
2025-12-25 @ 2:16 AM
Ignite Modification Date:
2025-12-29 @ 9:06 AM
Study NCT ID:
NCT04395560
Status:
COMPLETED
Last Update Posted:
2021-07-12
First Post:
2020-05-13
Is Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Highlighting the Benefits of a Screening Protocol Delivered by Orthoptists to Identify Visual Impairment in Children Aged 3 to 4
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': 300}, 'patientRegistry': False}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '2020-10-04', 'type': 'ACTUAL'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2021-07', 'completionDateStruct': {'date': '2021-06-28', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2021-07-09', 'studyFirstSubmitDate': '2020-05-13', 'studyFirstSubmitQcDate': '2020-05-19', 'lastUpdatePostDateStruct': {'date': '2021-07-12', 'type': 'ACTUAL'}, 'studyFirstPostDateStruct': {'date': '2020-05-20', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2021-06-28', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'The need to refer the child to an ophthalmologist (YES/NO)', 'timeFrame': 'through study completion, an average of 1 year', 'description': "the addressing requirements is evaluated by the orthoptist and ophthalmologist based on the patient's chart and clinical examinations"}], 'secondaryOutcomes': [{'measure': 'Score of parental satisfaction (algorithmically calculate)', 'timeFrame': 'through study completion, an average of 1 year', 'description': 'Assessed by the Likert scale (satisfaction questionnaire)'}, {'measure': 'The number of ophthalmologic consultations saved', 'timeFrame': 'through study completion, an average of 1 year', 'description': 'Evaluated according to the tariffs of the different nomenclatures of the acts'}]}, 'oversightModule': {'isFdaRegulatedDrug': False, 'isFdaRegulatedDevice': False}, 'conditionsModule': {'conditions': ['Visual Impairment in Children']}, 'referencesModule': {'references': [{'pmid': '39506219', 'type': 'DERIVED', 'citation': 'Lequeux L, Bonifas C, Alby A, Bontron C, Brovelli C, Huygens J, Norbert O, Pey C, Martinez L, Thouvenin Md D. Evaluation of the diagnostic parameters of the amblyopia and risk factors for amblyopia screening protocol in 3-year-olds according to recommendations from the French Association for Pediatric Ophthalmology and Strabismus (AFSOP) compared with reference ophthalmological examination: the ORTHOPHTALMO study. Strabismus. 2025 Jun;33(2):93-103. doi: 10.1080/09273972.2024.2422418. Epub 2024 Nov 6.'}]}, 'descriptionModule': {'briefSummary': "Visual developmental abnormalities affect 10 to 15% of the population under 6 years of age and leads to amblyopia in 30% of cases if left untreated. Untreated amblyopia in adulthood has consequences on the quality of life of individuals but will also represent a cost to society due to the increased risk of visual impairment.\n\nThe screening protocol for this study recommends that a screening examination for amblyopia and amblyogenic factors be routinely performed by an orthoptist in children between 3 and 4 year old. This examination should include, as a minimum, a standardised measurement of visual acuity, a cover test and a measurement of refraction by photoscreener. In the event of a positive screening, the child must then be referred to an ophthalmologist so as to complete an ophthalmological examination.\n\nThe aim of this protocol is to propose screening tests usually performed with a high specificity, in order to avoid congestion of ophthalmological services (i.e. by avoiding excessive or unnecessary referral of children to the ophthalmologist) without losing sensitivity by combining several tests.\n\nThe orthoptists' role in this screening protocol is to facilitate an extensive screening coverage of the population in this age group, as they are more easily accessed by the patients and more equitably spread in the community than ophthalmologists.\n\nTherefore, by initially screening and then referring less children to the ophthalmologist, the aim is to reduce waiting times in the access of ophthalmological services which could be detrimental in terms of treatment success rates for patients acutely needing care.\n\nBased on the referral of children between 3 and 4 years of age by the orthoptist to an ophthalmologist, the analysis of the data from the standard screening protocol used in our centre will enable us to validate it scientifically. The referral thresholds can thus be secondarily adjusted for each test if the initial objectives are not achieved (specificity \\> 90% and sensitivity \\> 87%). The aim of this study is also to observe a change in the patient flow by reducing the volume of consultations with the ophthalmologist currently required based on the present referral rate. The efficiency of the screening protocol by calculating the probable economic gain linked to the modification of the screening circuit will be secondarily studying in this protocol"}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['CHILD'], 'maximumAge': '4 Years', 'minimumAge': '3 Years', 'samplingMethod': 'NON_PROBABILITY_SAMPLE', 'studyPopulation': "Children from 3 to 4 years old, girls or boys, with a medical reason for consultation (paediatric orientation) or parent's request (child's complaint)", 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* Children from 3 to 4 years old consulting for a screening of visual disorders,\n* Patients registered with French social security scheme,\n* Not participating in any other clinical study,\n* Consent obtained from one of the two parents or the legal representative.\n\nExclusion Criteria:\n\n* Children whose parent or legal representative is vulnerable according to article L1121-6 of the CSP,\n* Children whose parent or legal guardian is under guardianship or trusteeship or under legal protection,\n* Children, whose parent or legal guardian is unable to give consent, or is protected by law.'}, 'identificationModule': {'nctId': 'NCT04395560', 'acronym': 'ORTHOPHTALMO', 'briefTitle': 'Highlighting the Benefits of a Screening Protocol Delivered by Orthoptists to Identify Visual Impairment in Children Aged 3 to 4', 'organization': {'class': 'OTHER', 'fullName': 'Clinique Rive Gauche'}, 'officialTitle': 'Highlighting the Benefits of a Screening Protocol Delivered by Orthoptists to Identify Visual Impairment in Children Aged 3 to 4', 'orgStudyIdInfo': {'id': '01/2020'}, 'secondaryIdInfos': [{'id': '2020-A00262-37', 'type': 'OTHER', 'domain': 'ID-RCB'}]}, 'contactsLocationsModule': {'locations': [{'zip': '31300', 'city': 'Toulouse', 'state': 'Occitanie', 'country': 'France', 'facility': 'Ophtalmologie Rive Gauche', 'geoPoint': {'lat': 43.60426, 'lon': 1.44367}}], 'overallOfficials': [{'name': 'Dominique Dr Thouvenin', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': 'Ophtalmologie Rive Gauche'}]}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Clinique Rive Gauche', 'class': 'OTHER'}, 'responsibleParty': {'type': 'SPONSOR'}}}}