Ignite Creation Date:
2025-12-25 @ 12:35 AM
Ignite Modification Date:
2026-04-13 @ 12:40 AM
Study NCT ID:
NCT02130167
Status:
COMPLETED
Last Update Posted:
2018-01-30
First Post:
2014-04-28
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Low Concentration Atropine for Myopia Progression in School Children
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'interventionBrowseModule': {'meshes': [{'id': 'D001285', 'term': 'Atropine'}], 'ancestors': [{'id': 'D001286', 'term': 'Atropine Derivatives'}, {'id': 'D014326', 'term': 'Tropanes'}, {'id': 'D053961', 'term': 'Azabicyclo Compounds'}, {'id': 'D001372', 'term': 'Aza Compounds'}, {'id': 'D009930', 'term': 'Organic Chemicals'}, {'id': 'D001533', 'term': 'Belladonna Alkaloids'}, {'id': 'D012991', 'term': 'Solanaceous Alkaloids'}, {'id': 'D000470', 'term': 'Alkaloids'}, {'id': 'D006571', 'term': 'Heterocyclic Compounds'}, {'id': 'D019086', 'term': 'Bridged Bicyclo Compounds, Heterocyclic'}, {'id': 'D006572', 'term': 'Heterocyclic Compounds, Bridged-Ring'}]}}, 'protocolSection': {'designModule': {'phases': ['NA'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'RANDOMIZED', 'maskingInfo': {'masking': 'TRIPLE', 'whoMasked': ['PARTICIPANT', 'CARE_PROVIDER', 'INVESTIGATOR']}, 'primaryPurpose': 'TREATMENT', 'interventionModel': 'PARALLEL'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 60}}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '2012-08'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2018-01', 'completionDateStruct': {'date': '2017-08', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2018-01-29', 'studyFirstSubmitDate': '2014-04-28', 'studyFirstSubmitQcDate': '2014-05-01', 'lastUpdatePostDateStruct': {'date': '2018-01-30', 'type': 'ACTUAL'}, 'studyFirstPostDateStruct': {'date': '2014-05-05', 'type': 'ESTIMATED'}, 'primaryCompletionDateStruct': {'date': '2017-07', 'type': 'ACTUAL'}}, 'outcomesModule': {'otherOutcomes': [{'measure': 'pupil size', 'timeFrame': '6 months', 'description': 'Using computer scaling software. unit: millimeter(mm)'}, {'measure': 'accommodation', 'timeFrame': '6 months', 'description': 'Using accommodometer to measuer accommodation. Unit: diopeter'}, {'measure': 'Questionnaire', 'timeFrame': 'baseline and 6 months', 'description': 'Questionnaire written by patients and their parents about how many hours per week of near work (ex. computer/video game, reading, piano playing...) and outdoor activities, the compliance of atropine use, discomfort after atropine use (ex. photophobia or blurred vision when near work)'}], 'primaryOutcomes': [{'measure': 'Cycloplegic spherical refraction change', 'timeFrame': '1 year', 'description': 'Cycloplegic spherical refraction change is the main indicator of the myopia progression.'}], 'secondaryOutcomes': [{'measure': 'Axial length change', 'timeFrame': '1 year', 'description': 'Axial length change is another indicator of the myopia progression.Using non-contact biometry. unit: millimeter(mm)'}]}, 'oversightModule': {'oversightHasDmc': True}, 'conditionsModule': {'keywords': ['Myopia progression', 'Low concentration atropine'], 'conditions': ['Myopia Progression']}, 'descriptionModule': {'briefSummary': 'Myopia is the leading cause of blindness in Taiwan. The younger children with myopia, the higher risk of high myopia in later life and complications such as retinal detachment and maculopathy will occur. We have reported the low concentration of atropine (0.05%) with the effect on retarding the myopia progression. Recently the 0.01% atropine was also reported effective and with less visual side effects such as mydriasis. The aim of this study is to compare the efficacy in controlling myopia progression and visual side effects of 2 low concentration of atropine(0.05% vs 0.01%) in children aged 6-12 years with myopia of at least -0.5 diopters (D) and astigmatism of -1.50 D or less.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['CHILD'], 'maximumAge': '12 Years', 'minimumAge': '6 Years', 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria:\n\nMyopia of at least -0.5 diopters (D) and astigmatism of -1.50 D or less.\n\nExclusion Criteria:\n\nstrabismus, amblyopia. cataract, glaucoma or any ocular diseases ocular surgery history systemic diseases (ex. asthma, heart disease...)'}, 'identificationModule': {'nctId': 'NCT02130167', 'briefTitle': 'Low Concentration Atropine for Myopia Progression in School Children', 'organization': {'class': 'OTHER', 'fullName': 'Chang Gung Memorial Hospital'}, 'officialTitle': 'Low Concentrations of Atropine for Controlling Myopia Progression in School Children', 'orgStudyIdInfo': {'id': 'CMRPG8C0601'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'EXPERIMENTAL', 'label': '0.01% Atropine', 'interventionNames': ['Drug: Atropine']}, {'type': 'ACTIVE_COMPARATOR', 'label': '0.05% Atropine', 'interventionNames': ['Drug: Atropine']}], 'interventions': [{'name': 'Atropine', 'type': 'DRUG', 'description': 'Compare different concentrations of atropine eye drops (0.01% vs 0.05%) in the efficacy of controlling myopia progression and side effects of atropine', 'armGroupLabels': ['0.01% Atropine', '0.05% Atropine']}]}, 'contactsLocationsModule': {'locations': [{'zip': '833', 'city': 'Kaohsiung City', 'country': 'Taiwan', 'facility': 'Kaohsiung Chang Gung Memorial Hospital', 'geoPoint': {'lat': 22.61626, 'lon': 120.31333}}], 'overallOfficials': [{'name': 'Pei-Chang Wu, MD,PhD', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': 'Dep. of Ophthalmology, Kaohsiung Chang Gung Memorial Hospital, Taiwan'}]}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Chang Gung Memorial Hospital', 'class': 'OTHER'}, 'responsibleParty': {'type': 'SPONSOR'}}}}