Ignite Creation Date:
2025-12-24 @ 1:28 PM
Ignite Modification Date:
2026-01-24 @ 9:39 PM
Study NCT ID:
NCT06738095
Status:
COMPLETED
Last Update Posted:
2024-12-17
First Post:
2024-12-13
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Effect of Low-level Red-light on Ultra-high Myopia
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': 'NA', 'maskingInfo': {'masking': 'NONE'}, 'primaryPurpose': 'TREATMENT', 'interventionModel': 'SINGLE_GROUP'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 57}}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '2022-01-18', 'type': 'ACTUAL'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2022-01', 'completionDateStruct': {'date': '2022-08-23', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2024-12-13', 'studyFirstSubmitDate': '2024-12-13', 'studyFirstSubmitQcDate': '2024-12-13', 'lastUpdatePostDateStruct': {'date': '2024-12-17', 'type': 'ACTUAL'}, 'studyFirstPostDateStruct': {'date': '2024-12-17', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2022-08-23', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Changes in axial length', 'timeFrame': 'one year', 'description': 'One year changes in axial length'}]}, 'oversightModule': {'isUsExport': False, 'oversightHasDmc': False, 'isFdaRegulatedDrug': False, 'isFdaRegulatedDevice': False}, 'conditionsModule': {'conditions': ['Myopia']}, 'descriptionModule': {'briefSummary': '100 eyes of ultra-high myopia were treated with daily low-level red-light. The age of children ranged from 3 to 16.3 years. The follow-up duration was one year. The objective was to explore the effect of daily low-level red-light on ultra-high myopia treatment'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['CHILD', 'ADULT'], 'maximumAge': '18 Years', 'minimumAge': '3 Years', 'healthyVolunteers': False, 'eligibilityCriteria': "Inclusion Criteria:\n\nA. The age is over 3 years old and under 18 years old. B. The spherical equivalent error is ≤ -6 D diopter . D. be able to cooperate to complete various eye examinations. E. be able to attend follow-up according to the specified time. F the guardian can accompany the use of the instrument.\n\nExclusion Criteria:\n\nA. Complications associated with high myopia (such as choroidal neovascularization, macular split or hole, Rhegmatogenous retinal detachment); B other macular diseases (central serous retinopathy) or other eye diseases (e.g.Glaucoma, cataract, uveitis); C complicated with photosensitivity, psoriasis, albinism, hyperactivity disorder, nephrotic syndrome and systemic erythema Immune system diseases such as lupus; D. other systemic diseases or pregnancy; E. other similar instruments have been used for treatment in the past six months.\n\nF. can't cooperate to complete various eye examinations. G. The guardian cannot accompany the use of this instrument."}, 'identificationModule': {'nctId': 'NCT06738095', 'briefTitle': 'Effect of Low-level Red-light on Ultra-high Myopia', 'organization': {'class': 'OTHER', 'fullName': 'Beijing Tongren Hospital'}, 'officialTitle': 'Effect of Low-level Red-light on Ultra-high Myopia', 'orgStudyIdInfo': {'id': 'BeijingTH TRECKY239'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'EXPERIMENTAL', 'label': 'red-light', 'description': 'Children with ultra-high myopia were treated with daily low-level red-light, which was used twice a day, with four hours interval. Three minutes for each session of treatment', 'interventionNames': ['Device: daily low-level red-light']}], 'interventions': [{'name': 'daily low-level red-light', 'type': 'DEVICE', 'description': 'Daily low-level red-light is a kind of myopia intervention. Red-light typically using 650-nm wave of length. The treatment duration last 3 minutes each time, every day children were anticipated to use two times, at home.', 'armGroupLabels': ['red-light']}]}, 'contactsLocationsModule': {'locations': [{'city': 'Beijing', 'state': 'China', 'country': 'China', 'facility': 'Beijing Tongren Hospital', 'geoPoint': {'lat': 39.9075, 'lon': 116.39723}}]}, 'ipdSharingStatementModule': {'ipdSharing': 'UNDECIDED'}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Beijing Tongren Hospital', 'class': 'OTHER'}, 'responsibleParty': {'type': 'PRINCIPAL_INVESTIGATOR', 'investigatorTitle': 'Dr', 'investigatorFullName': 'cao kai', 'investigatorAffiliation': 'Beijing Tongren Hospital'}}}}