Ignite Creation Date:
2025-12-25 @ 2:37 AM
Ignite Modification Date:
2025-12-31 @ 11:48 AM
Study NCT ID:
NCT04017234
Status:
UNKNOWN
Last Update Posted:
2020-05-13
First Post:
2019-07-10
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Eye Exercise, Transcutaneous Electrical Nerve Stimulation on Prevention of Myopia Progression
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': 'SINGLE', 'whoMasked': ['PARTICIPANT']}, 'primaryPurpose': 'PREVENTION', 'interventionModel': 'CROSSOVER'}, 'enrollmentInfo': {'type': 'ESTIMATED', 'count': 27}}, 'statusModule': {'overallStatus': 'UNKNOWN', 'lastKnownStatus': 'RECRUITING', 'startDateStruct': {'date': '2019-09-10', 'type': 'ACTUAL'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2020-05', 'completionDateStruct': {'date': '2020-08-30', 'type': 'ESTIMATED'}, 'lastUpdateSubmitDate': '2020-05-11', 'studyFirstSubmitDate': '2019-07-10', 'studyFirstSubmitQcDate': '2019-07-11', 'lastUpdatePostDateStruct': {'date': '2020-05-13', 'type': 'ACTUAL'}, 'studyFirstPostDateStruct': {'date': '2019-07-12', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2020-05-30', 'type': 'ESTIMATED'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'eyeball structure', 'timeFrame': 'one month detection after intervention', 'description': 'eyeball diopter detection'}], 'secondaryOutcomes': [{'measure': 'vision check', 'timeFrame': 'one month detection after intervention', 'description': "Sellen's vision chart"}]}, 'oversightModule': {'isFdaRegulatedDrug': False, 'isFdaRegulatedDevice': False}, 'conditionsModule': {'conditions': ['Myopia']}, 'descriptionModule': {'briefSummary': 'In Taiwan, the increasing prevalence of myopia shows a decline with age. Myopia has become a serious ocular problem in children because high myopia may lead to retinal damage, cataract and glaucoma. A prevention of myopia progression (PMP) will be developed and examined. This promotion program includes strategies such as a frequency following response, eye exercise, and transcutaneous electrical nerve stimulation on the prevention of myopia progression. Eye exercise defined as a computerized image led motion. The study aims to examine the effect of the implementation on the PMP.', 'detailedDescription': "This is an experimental study. A sample size of 25\\~40 participants from an elementary school will be recruited in the randomized controlled study.The sequential arrangement is arranged in a random manner for the participating children. A investigation of four groups will be designed for the PMP: Group 1 (frequency following response, Group 2(frequency following response,and eye exercise), Group 3 (frequency following response, eye exercise, transcutaneous electrical nerve stimulation and stimulating auricular acupoints), and Group 4, the control group. The PMP implement a 30 minute intervention two times per the investigators. Pre-test and post-test (eyeball diopter detection and Sellen's vision chart) will be carried out. The duration of each intervention is provided for two days. The washout period following next intervention is 7 days at least. After completing four intervention, the effect of the best intervention of eight the investigator will be conducted.The evaluation time of the interventions will be observed at first-time and one-month observations. A descriptive and inferential statistics by SpSS will be used for data analysis.\n\nThe investigators will apply the frequency following response, eye exercise, and transcutaneous electrical nerve stimulation on PMP among Taiwan schoolchildren. The findings of the study may provide information for promotion of visual health for schoolchildren and their parents."}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['CHILD'], 'maximumAge': '13 Years', 'minimumAge': '6 Years', 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* myopia is defined as the equivalent spherical surface degree of any one is less than or equal to -0.50D\n* do not use cyclogel or atropine\n* At least the eye ointment is deactivated for at least seven days\n* no plastic tablets are currently used\n* at least the plastic tablets are not allowed to be retired for more than seven days\n\nExclusion Criteria:\n\n* Children with current traumatic and unrecoverable other eye disease'}, 'identificationModule': {'nctId': 'NCT04017234', 'briefTitle': 'Eye Exercise, Transcutaneous Electrical Nerve Stimulation on Prevention of Myopia Progression', 'organization': {'class': 'OTHER', 'fullName': 'China Medical University Hospital'}, 'officialTitle': 'The Effects of Frequency Following Response, Eye Exercise, and Transcutaneous Electrical Nerve Stimulation on Prevention of Myopia Progression in Taiwan Schoolchildren', 'orgStudyIdInfo': {'id': 'CMUH107-REC1-124'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'EXPERIMENTAL', 'label': 'PMP group', 'description': 'children received health education for eye and the intervention(which included frequency following response, eye exercise, and transcutaneous electrical nerve stimulation) a 30 minute three times per week for four weeks.', 'interventionNames': ['Other: frequency following response, eye exercise, and transcutaneous']}, {'type': 'NO_INTERVENTION', 'label': 'control group', 'description': 'children just received health education for eye'}], 'interventions': [{'name': 'frequency following response, eye exercise, and transcutaneous', 'type': 'OTHER', 'description': 'frequency following response, eye exercise, and TENS for 3 times per week during 4 weeks', 'armGroupLabels': ['PMP group']}]}, 'contactsLocationsModule': {'locations': [{'zip': '406', 'city': 'Taichung', 'status': 'RECRUITING', 'country': 'Taiwan', 'contacts': [{'name': 'Yu-Kuei Teng, PhD', 'role': 'CONTACT', 'email': 'tengyk@mail.cmu.edu.tw', 'phone': '886-4-22053366', 'phoneExt': '7132'}, {'name': 'Shin-Da Lee, PhD', 'role': 'CONTACT', 'email': 'shinda@mail.cmu.edu.tw', 'phone': '886-4-22053366', 'phoneExt': '7300'}], 'facility': 'Chen Pin elementary school', 'geoPoint': {'lat': 24.1469, 'lon': 120.6839}}], 'centralContacts': [{'name': 'Yu-Kuei Teng', 'role': 'CONTACT', 'email': 'tengyk@mail.cmu.edu.tw', 'phone': '886-4-22053366', 'phoneExt': '7132'}], 'overallOfficials': [{'name': 'Yu-Kuei Teng', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': 'China Medical University, Taiwan'}]}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'China Medical University Hospital', 'class': 'OTHER'}, 'responsibleParty': {'type': 'SPONSOR'}}}}