Ignite Creation Date:
2025-12-25 @ 2:37 AM
Ignite Modification Date:
2025-12-26 @ 1:14 AM
Study NCT ID:
NCT03510234
Status:
UNKNOWN
Last Update Posted:
2018-07-06
First Post:
2018-02-26
Is NOT Gene Therapy:
False
Has Adverse Events:
False
Brief Title:
Self-confidence Study in Patients With Argus II Artificial Retina
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'conditionBrowseModule': {'meshes': [{'id': 'D012174', 'term': 'Retinitis Pigmentosa'}], 'ancestors': [{'id': 'D015785', 'term': 'Eye Diseases, Hereditary'}, {'id': 'D005128', 'term': 'Eye Diseases'}, {'id': 'D058499', 'term': 'Retinal Dystrophies'}, {'id': 'D012162', 'term': 'Retinal Degeneration'}, {'id': 'D012164', 'term': 'Retinal Diseases'}, {'id': 'D030342', 'term': 'Genetic Diseases, Inborn'}, {'id': 'D009358', 'term': 'Congenital, Hereditary, and Neonatal Diseases and Abnormalities'}]}}, 'protocolSection': {'designModule': {'studyType': 'OBSERVATIONAL', 'designInfo': {'timePerspective': 'PROSPECTIVE', 'observationalModel': 'COHORT'}, 'enrollmentInfo': {'type': 'ESTIMATED', 'count': 18}, 'patientRegistry': False}, 'statusModule': {'overallStatus': 'UNKNOWN', 'lastKnownStatus': 'RECRUITING', 'startDateStruct': {'date': '2018-02-23', 'type': 'ACTUAL'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2018-02', 'completionDateStruct': {'date': '2019-02', 'type': 'ESTIMATED'}, 'lastUpdateSubmitDate': '2018-07-04', 'studyFirstSubmitDate': '2018-02-26', 'studyFirstSubmitQcDate': '2018-04-25', 'lastUpdatePostDateStruct': {'date': '2018-07-06', 'type': 'ACTUAL'}, 'studyFirstPostDateStruct': {'date': '2018-04-27', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2019-02', 'type': 'ESTIMATED'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Self-confidence', 'timeFrame': '12 months', 'description': 'Evaluation of Self-confidence via a questionnaire'}]}, 'oversightModule': {'oversightHasDmc': False, 'isFdaRegulatedDrug': False, 'isFdaRegulatedDevice': False}, 'conditionsModule': {'keywords': ['Pigmentary retinopathy', 'Argus II retinal prosthesis', 'Self-confidence'], 'conditions': ['Pigmentary Retinopathy']}, 'descriptionModule': {'briefSummary': 'To evaluate whether the use of the Argus II retinal prosthesis improves the confidence and self-esteem of patients with advanced retinopathy pigmentosa'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'minimumAge': '18 Years', 'samplingMethod': 'NON_PROBABILITY_SAMPLE', 'studyPopulation': 'Patient already operated in France with artificial retina and having 1 year of follow-up', 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* Major patient (≥18 years old)\n* Patient already operated in France with artificial retina and having 1 year of follow-up\n* Patient who has agreed to use his medical data for research purposes\n\nExclusion Criteria:\n\n\\- Refusal to participate in the study'}, 'identificationModule': {'nctId': 'NCT03510234', 'briefTitle': 'Self-confidence Study in Patients With Argus II Artificial Retina', 'organization': {'class': 'OTHER', 'fullName': 'University Hospital, Strasbourg, France'}, 'officialTitle': 'Self-confidence Study in Patients With Argus II Artificial Retina', 'orgStudyIdInfo': {'id': '6954'}}, 'contactsLocationsModule': {'locations': [{'zip': '67091', 'city': 'Strasbourg', 'status': 'RECRUITING', 'country': 'France', 'contacts': [{'name': 'David GAUCHER, MD, PhD', 'role': 'CONTACT', 'email': 'david.gaucher@chru-strasbourg.fr', 'phone': '33 3 69 55 11 15'}, {'name': 'Arnaud Messerlin, MD', 'role': 'CONTACT', 'email': 'arnaud.messerlin@chru-strasbourg.fr', 'phone': '33 3 69 55 11 15'}, {'name': 'David GAUCHER, MD, PhD', 'role': 'PRINCIPAL_INVESTIGATOR'}, {'name': 'David Messerlin, MD', 'role': 'SUB_INVESTIGATOR'}], 'facility': "Service D'Ophtalmologie", 'geoPoint': {'lat': 48.58392, 'lon': 7.74553}}], 'centralContacts': [{'name': 'David GAUCHER, MD, PhD', 'role': 'CONTACT', 'email': 'david.gaucher@chru-strasbourg.fr', 'phone': '33 3 69 55 11 15'}, {'name': 'Arnaud Messerlin, MD', 'role': 'CONTACT', 'email': 'arnaud.messerlin@chru-strasbourg.fr', 'phone': '33 3 69 55 11 15'}], 'overallOfficials': [{'name': 'David GAUCHER, MD, PhD', 'role': 'STUDY_DIRECTOR', 'affiliation': 'University Hospital, Strasbourg, France'}]}, 'ipdSharingStatementModule': {'ipdSharing': 'NO'}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'University Hospital, Strasbourg, France', 'class': 'OTHER'}, 'responsibleParty': {'type': 'SPONSOR'}}}}