Ignite Creation Date:
2025-12-25 @ 3:23 AM
Ignite Modification Date:
2025-12-26 @ 2:03 AM
Study NCT ID:
NCT03586505
Status:
COMPLETED
Last Update Posted:
2019-09-17
First Post:
2018-07-03
Is NOT Gene Therapy:
False
Has Adverse Events:
False
Brief Title:
Tolerance to Light for Patients Suffering From Keratitis
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'conditionBrowseModule': {'meshes': [{'id': 'D007634', 'term': 'Keratitis'}, {'id': 'D015817', 'term': 'Eye Infections'}, {'id': 'D020795', 'term': 'Photophobia'}], 'ancestors': [{'id': 'D003316', 'term': 'Corneal Diseases'}, {'id': 'D005128', 'term': 'Eye Diseases'}, {'id': 'D007239', 'term': 'Infections'}, {'id': 'D014786', 'term': 'Vision Disorders'}, {'id': 'D012678', 'term': 'Sensation Disorders'}, {'id': 'D009461', 'term': 'Neurologic Manifestations'}, {'id': 'D009422', 'term': 'Nervous System Diseases'}, {'id': 'D012816', 'term': 'Signs and Symptoms'}, {'id': 'D013568', 'term': 'Pathological Conditions, Signs and Symptoms'}]}}, 'protocolSection': {'designModule': {'phases': ['NA'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'NA', 'maskingInfo': {'masking': 'NONE'}, 'primaryPurpose': 'BASIC_SCIENCE', 'interventionModel': 'SINGLE_GROUP', 'interventionModelDescription': 'Each patient is its own control'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 30}}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '2018-07-03', 'type': 'ACTUAL'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2019-09', 'completionDateStruct': {'date': '2019-08-07', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2019-09-16', 'studyFirstSubmitDate': '2018-07-03', 'studyFirstSubmitQcDate': '2018-07-03', 'lastUpdatePostDateStruct': {'date': '2019-09-17', 'type': 'ACTUAL'}, 'studyFirstPostDateStruct': {'date': '2018-07-13', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2019-08-07', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Light intensity', 'timeFrame': 'At the inclusion', 'description': 'For each wavelength, the highest light intensity tolerated by the patient is measured (mWatts/cm² )'}], 'secondaryOutcomes': [{'measure': 'Severity of the keratitis', 'timeFrame': 'At the inclusion', 'description': 'It is determined by slit lamp. The result is "severe" or "not severe"'}]}, 'oversightModule': {'oversightHasDmc': True, 'isFdaRegulatedDrug': False, 'isFdaRegulatedDevice': False}, 'conditionsModule': {'keywords': ['Keratitis', 'Eye Infection', 'Photophobia', 'Red light', 'Infrared light'], 'conditions': ['Keratitis']}, 'referencesModule': {'references': [{'pmid': '33038155', 'type': 'DERIVED', 'citation': 'Courrier E, Lambert V, Renault D, Garcin T, Moine B, Herbepin P, Thuret G, Gain P. Tolerance to Light of Patients Suffering From Infectious Keratitis. Cornea. 2021 Jan;40(1):5-11. doi: 10.1097/ICO.0000000000002516.'}]}, 'descriptionModule': {'briefSummary': 'In order to develop an innovative device to study infectious keratitis, we need to illuminate the cornea of patients suffering from an infectious keratitis with red or near-infrared light. Because of technical reasons the shortest possible wavelength (red) presents advantages.', 'detailedDescription': 'The aim of this preliminary study is to measure the maximal intensity tolerated during illumination with 6 wavelength corresponding : 2 red, 2 far red and 1 near infrared lights in order to determine the shortest wavelength well tolerated by patients, in comparison with the standard blue light illumination.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'minimumAge': '18 Years', 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* Social security insurance\n* Suspected infectious keratitis (clinically defined. No lab testing required)\n* Signed informed consent\n\nExclusion Criteria:\n\n* Major Blepharospasm\n* Aphakia (absence of lens)\n* Pregnant woman\n* Nursing mother'}, 'identificationModule': {'nctId': 'NCT03586505', 'acronym': 'EBLOUI', 'briefTitle': 'Tolerance to Light for Patients Suffering From Keratitis', 'organization': {'class': 'OTHER', 'fullName': 'Centre Hospitalier Universitaire de Saint Etienne'}, 'officialTitle': 'Tolerance to Light for Patients Suffering From Keratitis', 'orgStudyIdInfo': {'id': '1708072'}, 'secondaryIdInfos': [{'id': '2017-A03451-52', 'type': 'OTHER', 'domain': 'ANSM'}]}, 'armsInterventionsModule': {'armGroups': [{'type': 'EXPERIMENTAL', 'label': 'Light exposure', 'description': 'The keratitis eye of the patient is exposed to 6 lights with increasing intensity according to a constant speed.\n\nThe patients switch off the light when the discomfort is too elevated', 'interventionNames': ['Device: Light exposure']}], 'interventions': [{'name': 'Light exposure', 'type': 'DEVICE', 'description': 'The 6 lights used randomly are :\n\n* 482nm =standard blue light illumination,\n* 650nm,\n* 675nm,\n* 700nm,\n* 750nm\n* 800nm', 'armGroupLabels': ['Light exposure']}]}, 'contactsLocationsModule': {'locations': [{'zip': '42000', 'city': 'Saint-Etienne', 'country': 'France', 'facility': 'CHU de Saint-Etienne', 'geoPoint': {'lat': 45.43389, 'lon': 4.39}}], 'overallOfficials': [{'name': 'Gilles THURET, MD PhD', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': 'CHU de Saint-Etienne'}]}, 'ipdSharingStatementModule': {'ipdSharing': 'NO'}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Centre Hospitalier Universitaire de Saint Etienne', 'class': 'OTHER'}, 'collaborators': [{'name': 'University of Saint-Etienne', 'class': 'UNKNOWN'}], 'responsibleParty': {'type': 'SPONSOR'}}}}