Ignite Creation Date:
2025-12-24 @ 9:58 PM
Ignite Modification Date:
2026-04-21 @ 12:19 PM
Study NCT ID:
NCT02205632
Status:
COMPLETED
Last Update Posted:
2018-04-05
First Post:
2014-07-22
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Relationships Between Macular Pigment Optical Density and Lacquer Cracks in High Myopic Patients.
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}}, 'protocolSection': {'designModule': {'phases': ['NA'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'NON_RANDOMIZED', 'maskingInfo': {'masking': 'NONE'}}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 39}}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '2014-02', 'type': 'ACTUAL'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2018-04', 'completionDateStruct': {'date': '2014-11', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2018-04-03', 'studyFirstSubmitDate': '2014-07-22', 'studyFirstSubmitQcDate': '2014-07-30', 'lastUpdatePostDateStruct': {'date': '2018-04-05', 'type': 'ACTUAL'}, 'studyFirstPostDateStruct': {'date': '2014-07-31', 'type': 'ESTIMATED'}, 'primaryCompletionDateStruct': {'date': '2014-11', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Association between lacquer cracks related to high myopia and the macular pigment optical density', 'timeFrame': '1 day'}], 'secondaryOutcomes': [{'measure': 'The macular pigment optical density among high myopic patients', 'timeFrame': '1 day'}]}, 'conditionsModule': {'conditions': ['High Myopia']}, 'descriptionModule': {'briefSummary': 'Lutein ans zeaxanthin, carotenoids provided by dietary intake are mainly located in the macular area.\n\nIts absorption peak at 460 nm may reduce photic damages. The macular pigment density can be evaluated by its optical density.\n\nReduced macular pigment level is a significant risk factor for age-macular degeneration. The nutritional intake can minimise the risk of age-macular degeneration.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'minimumAge': '18 Years', 'healthyVolunteers': False, 'eligibilityCriteria': "Inclusion Criteria:\n\n* Age \\>18 years-old\n* High axial myopia \\< -6 dioptries\n* Presence or not of lacquer cracks in Bruch's membrane in one or both eyes\n* Patients with social security coverage\n\nExclusion Criteria:\n\n* Age \\<18 years-old\n* Amblyopia in the studied eye\n* Prior ocular surgery\n* Corneal disease or severe dry eye syndrome\n* Other retinal disease: diabetic retinopathy, age-related macular degeneration, macular hole, epiretinal membrane central\n* Extensive chorioretinal atrophy\n* Allergy to tropicamide\n* Pregnancy"}, 'identificationModule': {'nctId': 'NCT02205632', 'briefTitle': 'Relationships Between Macular Pigment Optical Density and Lacquer Cracks in High Myopic Patients.', 'organization': {'class': 'OTHER', 'fullName': 'Poitiers University Hospital'}, 'orgStudyIdInfo': {'id': 'MPSII-RMB'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'OTHER', 'label': 'High myopic patients with lacker craks', 'interventionNames': ['Device: MPS II']}, {'type': 'OTHER', 'label': 'High myopic patients without lacker cracks', 'interventionNames': ['Device: MPS II']}], 'interventions': [{'name': 'MPS II', 'type': 'DEVICE', 'armGroupLabels': ['High myopic patients with lacker craks', 'High myopic patients without lacker cracks']}]}, 'contactsLocationsModule': {'locations': [{'zip': '86021', 'city': 'Poitiers', 'state': 'Vienne', 'country': 'France', 'facility': 'ophthalmology department, Poitiers University Hospital', 'geoPoint': {'lat': 46.58261, 'lon': 0.34348}}], 'overallOfficials': [{'name': 'Nicolas LEVEZIEL, MD, PhD', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': 'Poitiers University Hospital'}]}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Poitiers University Hospital', 'class': 'OTHER'}, 'responsibleParty': {'type': 'SPONSOR'}}}}