Ignite Creation Date:
2025-12-25 @ 2:12 AM
Ignite Modification Date:
2026-02-21 @ 2:54 PM
Study NCT ID:
NCT02064660
Status:
COMPLETED
Last Update Posted:
2015-09-03
First Post:
2014-02-13
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
The Efficacy and Safety of Periocular Acupoint Stimulation on Myopia Progression in Children
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'conditionBrowseModule': {'meshes': [{'id': 'D009216', 'term': 'Myopia'}, {'id': 'D012030', 'term': 'Refractive Errors'}], 'ancestors': [{'id': 'D005128', 'term': 'Eye Diseases'}]}}, 'protocolSection': {'designModule': {'phases': ['PHASE1'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'NA', 'maskingInfo': {'masking': 'NONE'}, 'primaryPurpose': 'PREVENTION', 'interventionModel': 'SINGLE_GROUP'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 20}}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '2013-12'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2015-09', 'completionDateStruct': {'date': '2014-12', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2015-09-02', 'studyFirstSubmitDate': '2014-02-13', 'studyFirstSubmitQcDate': '2014-02-13', 'lastUpdatePostDateStruct': {'date': '2015-09-03', 'type': 'ESTIMATED'}, 'studyFirstPostDateStruct': {'date': '2014-02-17', 'type': 'ESTIMATED'}, 'primaryCompletionDateStruct': {'date': '2014-12', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Refractive error', 'timeFrame': '6 months', 'description': 'Change from baseline in the refractive erros will be used.'}], 'secondaryOutcomes': [{'measure': 'Axial length', 'timeFrame': '6 months', 'description': 'Change from baseline in the axial length will be used.'}]}, 'oversightModule': {'oversightHasDmc': True}, 'conditionsModule': {'keywords': ['Myopia', 'Children', 'Acupressure', 'Refractive error', 'Axial length', 'Korean medicine'], 'conditions': ['Myopia']}, 'descriptionModule': {'briefSummary': 'Myopia is widely one of the three commonly detected refractive errors. Myopia is usually managed by correction through glasses or contact lenses. Other alternative available include surgery, drugs and acupuncture. There are various therapeutic approaches and different points can be used in acupuncture treatment for myopia, such as auricular acupuncture, acupressure body acupuncture. However, the mechanism of acupuncture therapy for myopia is largely unknown. Furthermore, little information exists regarding the effects and safety of acupuncture for degenerative myopia in children.\n\nThe investigators aimed to assess the overall effectiveness, safety of periocular acupressure for children with myopia\n\nThe hypotheses of this study are as follows:\n\nPeriocular acupressure is effective for myopia progression delay.\n\nThe study aims to include 56 participants.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['CHILD'], 'maximumAge': '12 Years', 'minimumAge': '7 Years', 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* Aged 7-12 years\n* Spherical equivalent greater than -5D\n* Individuals without strabismus, anistopia\n* Willingness to participate in the study\n\nExclusion Criteria:\n\n* The presence of a related disease such as cataract, glaucoma, or other eye disease.\n* Individuals who were received ocular or scalp trauma.\n* Individuals who were received ocular surgery and had ocular wound.\n* Individuals who were adapted bifocal lense.\n* Individuals suffering fever or bad conditions.\n* Individuals suffering systemic or neurologic disease.\n* Indibiduals who were receiving other therapy during the period of study\n* Individuals who did not comply with the treatment which affected myopia progression.'}, 'identificationModule': {'nctId': 'NCT02064660', 'briefTitle': 'The Efficacy and Safety of Periocular Acupoint Stimulation on Myopia Progression in Children', 'organization': {'class': 'OTHER', 'fullName': 'Korean Medicine Hospital of Pusan National University'}, 'officialTitle': 'An Integrative Medical Approach of Acupoint Stimulation for Children With Myopia : A Pilot Study', 'orgStudyIdInfo': {'id': 'blueicek'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'EXPERIMENTAL', 'label': 'single arm', 'description': 'A series of acupressure sessions within six months from the baseline', 'interventionNames': ['Device: massager']}], 'interventions': [{'name': 'massager', 'type': 'DEVICE', 'otherNames': ['proprietary name : Nurieye-1'], 'description': 'The patients will be doing self-stimulation using acupressure device, The acupuncture treatment will be applied two times per day for six months. Acupressure divice will stimulate for 14 minutes. Examples of acupuncture points to be used might include GB1, GB14, TE23, ST1, ST2, BL01, BL02, the Extra-point Tae-yang, In-dang.', 'armGroupLabels': ['single arm']}]}, 'contactsLocationsModule': {'locations': [{'zip': '626-770', 'city': 'Yangsan', 'state': 'Gyeongsangnam-do', 'country': 'South Korea', 'facility': 'Pusan National University Korean Medicine Hospital', 'geoPoint': {'lat': 35.34199, 'lon': 129.03358}}], 'overallOfficials': [{'name': 'Ki-bong Kim', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': 'Pusan National University Korean Medicine Hospital'}]}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Korean Medicine Hospital of Pusan National University', 'class': 'OTHER'}, 'collaborators': [{'name': 'Korea Institute of Oriental Medicine', 'class': 'OTHER_GOV'}], 'responsibleParty': {'type': 'PRINCIPAL_INVESTIGATOR', 'investigatorTitle': 'Assistant Professor', 'investigatorFullName': 'Ki-Bong, Kim', 'investigatorAffiliation': 'Korean Medicine Hospital of Pusan National University'}}}}