Ignite Creation Date:
2025-12-24 @ 11:28 PM
Ignite Modification Date:
2026-01-01 @ 4:22 PM
Study NCT ID:
NCT05478356
Status:
UNKNOWN
Last Update Posted:
2022-07-28
First Post:
2022-07-26
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
The Effects of Low-dose Atropine and Orthokeratology in Pediatric Myopia Control
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'conditionBrowseModule': {'meshes': [{'id': 'D009216', 'term': 'Myopia'}], 'ancestors': [{'id': 'D012030', 'term': 'Refractive Errors'}, {'id': 'D005128', 'term': 'Eye Diseases'}]}}, 'protocolSection': {'designModule': {'phases': ['NA'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'RANDOMIZED', 'maskingInfo': {'masking': 'DOUBLE', 'whoMasked': ['INVESTIGATOR', 'OUTCOMES_ASSESSOR']}, 'primaryPurpose': 'TREATMENT', 'interventionModel': 'PARALLEL'}, 'enrollmentInfo': {'type': 'ESTIMATED', 'count': 100}}, 'statusModule': {'overallStatus': 'UNKNOWN', 'lastKnownStatus': 'RECRUITING', 'startDateStruct': {'date': '2022-08-01', 'type': 'ESTIMATED'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2022-07', 'completionDateStruct': {'date': '2023-08-31', 'type': 'ESTIMATED'}, 'lastUpdateSubmitDate': '2022-07-26', 'studyFirstSubmitDate': '2022-07-26', 'studyFirstSubmitQcDate': '2022-07-26', 'lastUpdatePostDateStruct': {'date': '2022-07-28', 'type': 'ACTUAL'}, 'studyFirstPostDateStruct': {'date': '2022-07-28', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2023-08-31', 'type': 'ESTIMATED'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Progression of myopia', 'timeFrame': '1 year', 'description': 'The change of myopia (Ds)'}, {'measure': 'Progression of axial length', 'timeFrame': '1 year', 'description': 'The change of axial length (mm)'}]}, 'oversightModule': {'isFdaRegulatedDrug': False, 'isFdaRegulatedDevice': False}, 'conditionsModule': {'conditions': ['Myopia']}, 'descriptionModule': {'briefSummary': 'Both orthokeratology and atropine eye drops are effective methods for myopia control, but few studies have compared them all together simultaneously. Therefore, the primary aim of the present study was to compare the effect of orthokeratology versus low-dose (0.01% and 0.02%) atropine on the control of myopia progression.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['CHILD', 'ADULT'], 'maximumAge': '18 Years', 'minimumAge': '8 Years', 'healthyVolunteers': True, 'eligibilityCriteria': 'Inclusion Criteria:\n\nBest corrected visual acuity less then 0.00 log MAR (minimum angle of resolution) units Cycloplegic SER of - 1.0 D or less in both eyes. An inter-eye cycloplegic SER difference of 1.00 D or more.\n\nExclusion Criteria:\n\nChildren with cycloplegic cylinder refraction of more than + 1.00 D or less than - 1.00 D.\n\nHistory of binocular vision problems, including strabismus. History of known ocular disorders, including media opacities, macular dysgenesis, optic nerve hypoplasia, perinatal brain injury, buphthalmos, and retinopathy of prematurity.\n\nHistory of medication use that might have affected the refractive results. Systemic or developmental problems that might have hindered refractive development.'}, 'identificationModule': {'nctId': 'NCT05478356', 'acronym': 'AVO', 'briefTitle': 'The Effects of Low-dose Atropine and Orthokeratology in Pediatric Myopia Control', 'organization': {'class': 'OTHER', 'fullName': 'Evidence Based Cataract Study Group'}, 'officialTitle': 'The Effects of Low-dose Atropine and Orthokeratology in Pediatric Myopia Control', 'orgStudyIdInfo': {'id': 'EvidenceBCSG'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'EXPERIMENTAL', 'label': 'orthokeratology group', 'interventionNames': ['Device: orthokeratology']}, {'type': 'ACTIVE_COMPARATOR', 'label': 'low-dose atropine group', 'interventionNames': ['Drug: low-dose atropine eye drops']}], 'interventions': [{'name': 'low-dose atropine eye drops', 'type': 'DRUG', 'description': 'low-dose atropine eye drops', 'armGroupLabels': ['low-dose atropine group']}, {'name': 'orthokeratology', 'type': 'DEVICE', 'description': 'orthokeratology, ortho-K lenses', 'armGroupLabels': ['orthokeratology group']}]}, 'contactsLocationsModule': {'locations': [{'zip': '100038', 'city': 'Beijing', 'state': 'Beijing Municipality', 'status': 'RECRUITING', 'country': 'China', 'contacts': [{'name': 'Peng Zhou, M.D.', 'role': 'CONTACT', 'email': 'drzhoupeng@gmail.com', 'phone': '17898805125'}], 'facility': 'Visionly Eye Hospital', 'geoPoint': {'lat': 39.9075, 'lon': 116.39723}}, {'zip': '200001', 'city': 'Shanghai', 'state': 'Shanghai Municipality', 'status': 'RECRUITING', 'country': 'China', 'contacts': [{'name': 'Peng Zhou, M.D.', 'role': 'CONTACT', 'email': 'drzhoupeng@gmail.com', 'phone': '17898805125'}], 'facility': 'Parkway Hospital', 'geoPoint': {'lat': 31.22222, 'lon': 121.45806}}], 'centralContacts': [{'name': 'Peng Zhou, M.D.', 'role': 'CONTACT', 'email': 'drzhoupeng@gmail.com', 'phone': '17898805125'}]}, 'ipdSharingStatementModule': {'ipdSharing': 'UNDECIDED'}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Evidence Based Cataract Study Group', 'class': 'OTHER'}, 'responsibleParty': {'type': 'PRINCIPAL_INVESTIGATOR', 'investigatorTitle': 'Doctor', 'investigatorFullName': 'Peng ZHOU', 'investigatorAffiliation': 'Evidence Based Cataract Study Group'}}}}