Ignite Creation Date:
2025-12-25 @ 12:16 AM
Ignite Modification Date:
2026-02-26 @ 8:12 PM
Study NCT ID:
NCT02594358
Status:
WITHDRAWN
Last Update Posted:
2017-03-07
First Post:
2015-10-30
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Caffeine in Amblyopia Study
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'conditionBrowseModule': {'meshes': [{'id': 'D000550', 'term': 'Amblyopia'}], 'ancestors': [{'id': 'D001927', 'term': 'Brain Diseases'}, {'id': 'D002493', 'term': 'Central Nervous System Diseases'}, {'id': 'D009422', 'term': 'Nervous System Diseases'}, {'id': 'D014786', 'term': 'Vision Disorders'}, {'id': 'D012678', 'term': 'Sensation Disorders'}, {'id': 'D009461', 'term': 'Neurologic Manifestations'}, {'id': 'D005128', 'term': 'Eye Diseases'}, {'id': 'D012816', 'term': 'Signs and Symptoms'}, {'id': 'D013568', 'term': 'Pathological Conditions, Signs and Symptoms'}]}, 'interventionBrowseModule': {'meshes': [{'id': 'D002110', 'term': 'Caffeine'}], 'ancestors': [{'id': 'D014970', 'term': 'Xanthines'}, {'id': 'D000470', 'term': 'Alkaloids'}, {'id': 'D006571', 'term': 'Heterocyclic Compounds'}, {'id': 'D011688', 'term': 'Purinones'}, {'id': 'D011687', 'term': 'Purines'}, {'id': 'D006574', 'term': 'Heterocyclic Compounds, 2-Ring'}, {'id': 'D000072471', 'term': 'Heterocyclic Compounds, Fused-Ring'}]}}, 'protocolSection': {'designModule': {'phases': ['PHASE1', 'PHASE2'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'RANDOMIZED', 'maskingInfo': {'masking': 'SINGLE', 'whoMasked': ['OUTCOMES_ASSESSOR']}, 'primaryPurpose': 'TREATMENT', 'interventionModel': 'SINGLE_GROUP'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 0}}, 'statusModule': {'whyStopped': 'Could not recruit', 'overallStatus': 'WITHDRAWN', 'startDateStruct': {'date': '2014-10'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2017-03', 'completionDateStruct': {'date': '2018-12', 'type': 'ESTIMATED'}, 'lastUpdateSubmitDate': '2017-03-06', 'studyFirstSubmitDate': '2015-10-30', 'studyFirstSubmitQcDate': '2015-10-30', 'lastUpdatePostDateStruct': {'date': '2017-03-07', 'type': 'ACTUAL'}, 'studyFirstPostDateStruct': {'date': '2015-11-03', 'type': 'ESTIMATED'}, 'primaryCompletionDateStruct': {'date': '2017-12', 'type': 'ESTIMATED'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Visual acuity', 'timeFrame': '12 weeks', 'description': 'Quantitative improvement in high resolution visual acuity measured at 3 meters'}], 'secondaryOutcomes': [{'measure': 'Questionnaire', 'timeFrame': '12 weeks', 'description': 'A multiquestion survey is adminsitered to the subjects specifically asking about side effects and quality of life'}]}, 'oversightModule': {'oversightHasDmc': False}, 'conditionsModule': {'keywords': ['Caffeine'], 'conditions': ['Amblyopia']}, 'descriptionModule': {'briefSummary': 'Prospective data on the visual acuity response in children treated by patching concurrently treated with caffeine and estimate the magnitude of effect that might be seen in a randomized trial (if no improvement in acuity is seen, this would be sufficient evidence to decide not to conduct a randomized, double blind trial).\n\nCollect prospective data on the tolerability of caffeine in two dosages as an adjuvant treatment for amblyopia and provide limited data on its safety.\n\nEvaluate the potential for a dietary intervention to enhance the acceptance and tolerability of patching on the child and family.\n\nDemonstrate recruitment potential of subjects to participate in a dietary intervention study.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['CHILD'], 'maximumAge': '13 Years', 'minimumAge': '7 Years', 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* Amblyopia from strabismus and amblyopia\n\nExclusion Criteria:\n\n* Known intolerance to caffeine\n* Diagnosis and/or treatment of attention deficit/hyperactivity disorder\n* Presence of an ocular cause for reduced visual acuity\n* Myopia with a special equivalent -6.00 diopters\n* Current vision therapy or orthoptics - any type\n* Ocular cause for reduced visual acuity\n* Prior intraocular or refractive surgery\n* History of narrow-angle glaucoma\n* Strabismus surgery planned within 16 weeks\n* Nystagmus per se does not exclude the subject if the above visual acuity criteria are met\n* Known skin reactions to patch or bandage adhesives\n* Known allergy or intolerance to food dyes\n* Current treatment with topical atropine eyedrops\n* Menarche, pregnancy or lactation\n* Use of any of the following medications which may affect caffeine metabolism: nafcillin, verapamil, fluvoxamine, ciprofloxacin and other fluoroquinolones, modafinil, nafcillin, and omeprazole'}, 'identificationModule': {'nctId': 'NCT02594358', 'acronym': 'CAS', 'briefTitle': 'Caffeine in Amblyopia Study', 'organization': {'class': 'OTHER', 'fullName': 'Johns Hopkins University'}, 'orgStudyIdInfo': {'id': 'NA_00066787'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'ACTIVE_COMPARATOR', 'label': 'Caffeine 20 mg', 'description': 'Patching plus once daily caffeine for 12 weeks', 'interventionNames': ['Drug: Caffeine']}, {'type': 'ACTIVE_COMPARATOR', 'label': 'Caffeine 40 mg', 'description': 'Patching plus once daily caffeine for 12 weeks', 'interventionNames': ['Drug: Caffeine']}], 'interventions': [{'name': 'Caffeine', 'type': 'DRUG', 'description': '20 MG OR 40 MG ONCE DAILY ALONG WITH PATCHING', 'armGroupLabels': ['Caffeine 20 mg', 'Caffeine 40 mg']}]}, 'contactsLocationsModule': {'locations': [{'zip': '21287', 'city': 'Baltimore', 'state': 'Maryland', 'country': 'United States', 'facility': 'Johns Hopkins University', 'geoPoint': {'lat': 39.29038, 'lon': -76.61219}}], 'overallOfficials': [{'name': 'Michael X Repka, MD, MBA', 'role': 'STUDY_CHAIR', 'affiliation': 'Johns Hopkins University'}]}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Johns Hopkins University', 'class': 'OTHER'}, 'responsibleParty': {'type': 'PRINCIPAL_INVESTIGATOR', 'investigatorTitle': 'Professor of Ophthalmology', 'investigatorFullName': 'Michael Repka', 'investigatorAffiliation': 'Johns Hopkins University'}}}}