Ignite Creation Date:
2025-12-25 @ 4:54 AM
Ignite Modification Date:
2025-12-26 @ 3:54 AM
Study NCT ID:
NCT03437018
Status:
COMPLETED
Last Update Posted:
2023-02-16
First Post:
2018-01-26
Is NOT Gene Therapy:
False
Has Adverse Events:
False
Brief Title:
MONITORING OF MODERATE DIABETIC RETINOPATHY BY TELE-EXPERTISE
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'conditionBrowseModule': {'meshes': [{'id': 'D003930', 'term': 'Diabetic Retinopathy'}], 'ancestors': [{'id': 'D012164', 'term': 'Retinal Diseases'}, {'id': 'D005128', 'term': 'Eye Diseases'}, {'id': 'D003925', 'term': 'Diabetic Angiopathies'}, {'id': 'D014652', 'term': 'Vascular Diseases'}, {'id': 'D002318', 'term': 'Cardiovascular Diseases'}, {'id': 'D048909', 'term': 'Diabetes Complications'}, {'id': 'D003920', 'term': 'Diabetes Mellitus'}, {'id': 'D004700', 'term': 'Endocrine System Diseases'}]}}, 'protocolSection': {'designModule': {'studyType': 'OBSERVATIONAL', 'designInfo': {'timePerspective': 'PROSPECTIVE', 'observationalModel': 'CASE_CROSSOVER'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 97}, 'patientRegistry': False}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '2019-10-10', 'type': 'ACTUAL'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2023-02', 'completionDateStruct': {'date': '2022-06-16', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2023-02-15', 'studyFirstSubmitDate': '2018-01-26', 'studyFirstSubmitQcDate': '2018-02-12', 'lastUpdatePostDateStruct': {'date': '2023-02-16', 'type': 'ACTUAL'}, 'studyFirstPostDateStruct': {'date': '2018-02-19', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2022-06-16', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'classification of diabetic retinopathy (DR)', 'timeFrame': '1 month', 'description': 'DR is classified in 3 stages : moderate non proliferative DR, severe non proliferative DR, and proliferative DR'}], 'secondaryOutcomes': [{'measure': 'classification of macular edema', 'timeFrame': '1 month', 'description': 'macular edema (ME) is classified in 4 stages : no ME , mild ME, moderate ME, severe ME'}, {'measure': 'follow-up strategy', 'timeFrame': '1 month', 'description': 'follow-up strategy can take to ways : no treatment required and continuation of the monitoring/ complementary exam or treatment required'}, {'measure': 'medical time necessary for examination and analyse', 'timeFrame': '1 month', 'description': 'time necessary for direct examination and analyse by ophthalmologist on-site and time necessary for remote analyse are measured'}]}, 'oversightModule': {'oversightHasDmc': True, 'isFdaRegulatedDrug': False, 'isFdaRegulatedDevice': False}, 'conditionsModule': {'keywords': ['moderate diabetic retinopathy', 'tele-expertise'], 'conditions': ['Diabetic Retinopathy']}, 'referencesModule': {'references': [{'pmid': '22765981', 'type': 'BACKGROUND', 'citation': 'Schulze-Dobold C, Erginay A, Robert N, Chabouis A, Massin P. Ophdiat((R)): five-year experience of a telemedical screening programme for diabetic retinopathy in Paris and the surrounding area. Diabetes Metab. 2012 Nov;38(5):450-7. doi: 10.1016/j.diabet.2012.05.003. Epub 2012 Jul 4.'}, {'pmid': '19349202', 'type': 'BACKGROUND', 'citation': "Chabouis A, Berdugo M, Meas T, Erginay A, Laloi-Michelin M, Jouis V, Guillausseau PJ, M'bemba J, Chaine G, Slama G, Cohen R, Reach G, Marre M, Chanson P, Vicaut E, Massin P. Benefits of Ophdiat, a telemedical network to screen for diabetic retinopathy: a retrospective study in five reference hospital centres. Diabetes Metab. 2009 Jun;35(3):228-32. doi: 10.1016/j.diabet.2008.12.001. Epub 2009 Apr 5."}, {'pmid': '18424210', 'type': 'BACKGROUND', 'citation': 'Erginay A, Chabouis A, Viens-Bitker C, Robert N, Lecleire-Collet A, Massin P. OPHDIAT: quality-assurance programme plan and performance of the network. Diabetes Metab. 2008 Jun;34(3):235-42. doi: 10.1016/j.diabet.2008.01.004.'}]}, 'descriptionModule': {'briefSummary': 'The aim of this study is to evaluate the monitoring of moderate diabetic retinopathy by tele-expertise', 'detailedDescription': 'This study compares 2 strategies of monitoring of moderate diabetic retinopathy (RD).After a consultation with an orthoptist for measurement of visual acuity, measurement of ocular tone by pulsed air tonometer, retinography pictures (9 photographs: one of the posterior pole and 8 of the retinal periphery) and Optical Coherence Tomography (OCT), results are evaluated on-site by an ophthalmologist and then sent through a secure medical online application to an ophthalmologist expert in RD for assessment. Each patient is his own control.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'minimumAge': '18 Years', 'samplingMethod': 'NON_PROBABILITY_SAMPLE', 'studyPopulation': 'patient with complicated diabetes mellitus with moderate retinopathy requiring periodic follow-up by an ophthalmologist', 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* patient with complicated diabetes mellitus with moderate retinopathy\n\nExclusion Criteria:\n\n* Patient deprived of liberty by judicial or administrative decision\n* Person subject to a legal protection measure\n* Patient already involved in another clinical trial protocol'}, 'identificationModule': {'nctId': 'NCT03437018', 'acronym': 'TELERETINODIAB', 'briefTitle': 'MONITORING OF MODERATE DIABETIC RETINOPATHY BY TELE-EXPERTISE', 'organization': {'class': 'OTHER', 'fullName': 'Centre Hospitalier Sud Francilien'}, 'officialTitle': 'COMPARISON OF MONITORING OF MODERATE DIABETIC RETINOPATHY BY TELE-EXPERTISE AND CONVENTIONAL OPHTHALMOLOGICAL CONSULTATION', 'orgStudyIdInfo': {'id': 'ID RCB 2017-A02329-44'}}, 'armsInterventionsModule': {'interventions': [{'name': 'moderate diabetic retinopathy follow-up by tele-expertise', 'type': 'OTHER', 'description': 'Consultation by an orthoptist to measure visual acuity, eye tone by pulsed air tonometer, and retinography images after pupillary dilatation (9 photographs: one of the posterior pole and 8 of the peripheral retina) and optical coherence tomography (OCT).\n\nThe results are immediately evaluated on site by an ophthalmologist. The results are sent through a secure online medical application to a diabetic retinopathy specialist ophthalmologist for evaluation.'}]}, 'contactsLocationsModule': {'locations': [{'zip': '91106', 'city': 'Corbeil-Essonnes', 'country': 'France', 'facility': 'Centre Hospitalier Sud Francilien', 'geoPoint': {'lat': 48.60603, 'lon': 2.48757}}], 'overallOfficials': [{'name': 'Alfred Penfornis', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': 'Centre Hospitalier Sud Francilien'}]}, 'ipdSharingStatementModule': {'ipdSharing': 'NO'}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Centre Hospitalier Sud Francilien', 'class': 'OTHER'}, 'responsibleParty': {'type': 'SPONSOR'}}}}