Ignite Creation Date:
2025-12-25 @ 12:10 AM
Ignite Modification Date:
2026-02-25 @ 6:55 PM
Study NCT ID:
NCT05957458
Status:
COMPLETED
Last Update Posted:
2023-07-24
First Post:
2023-05-23
Is Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Myopia Control With Three Lever Irradiance of PBM Therapy in Children and Adults
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'conditionBrowseModule': {'meshes': [{'id': 'D009216', 'term': 'Myopia'}, {'id': 'D000550', 'term': 'Amblyopia'}, {'id': 'D012030', 'term': 'Refractive Errors'}], 'ancestors': [{'id': 'D005128', 'term': 'Eye Diseases'}, {'id': 'D001927', 'term': 'Brain Diseases'}, {'id': 'D002493', 'term': 'Central Nervous System Diseases'}, {'id': 'D009422', 'term': 'Nervous System Diseases'}, {'id': 'D014786', 'term': 'Vision Disorders'}, {'id': 'D012678', 'term': 'Sensation Disorders'}, {'id': 'D009461', 'term': 'Neurologic Manifestations'}, {'id': 'D012816', 'term': 'Signs and Symptoms'}, {'id': 'D013568', 'term': 'Pathological Conditions, Signs and Symptoms'}]}, 'interventionBrowseModule': {'meshes': [{'id': 'D028022', 'term': 'Low-Level Light Therapy'}], 'ancestors': [{'id': 'D053685', 'term': 'Laser Therapy'}, {'id': 'D013812', 'term': 'Therapeutics'}, {'id': 'D010789', 'term': 'Phototherapy'}]}}, 'protocolSection': {'designModule': {'phases': ['NA'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'NON_RANDOMIZED', 'maskingInfo': {'masking': 'NONE', 'maskingDescription': 'No mask for all. Open and retrospective study.'}, 'primaryPurpose': 'TREATMENT', 'interventionModel': 'PARALLEL', 'interventionModelDescription': 'Three groups are all treated with PBM therapy with follow-up but they irradiance is different while one group is as the control.'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 300}}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '2021-01-01', 'type': 'ACTUAL'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2023-07', 'completionDateStruct': {'date': '2023-05-31', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2023-07-20', 'studyFirstSubmitDate': '2023-05-23', 'studyFirstSubmitQcDate': '2023-07-20', 'lastUpdatePostDateStruct': {'date': '2023-07-24', 'type': 'ACTUAL'}, 'studyFirstPostDateStruct': {'date': '2023-07-24', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2022-12-31', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Axial length shortening comparing to that value of baseline (mm）', 'timeFrame': '12-month', 'description': 'Measured with optial coherent methods with the same device assistant with the same techinician'}, {'measure': 'Axial length shortening comparing to that value of baseline (mm）', 'timeFrame': '1-month', 'description': 'Measured with optial coherent methods with the same device assistant with the techinician'}, {'measure': 'Axial length shortening comparing to that value of baseline (mm）', 'timeFrame': '6-month', 'description': 'Measured with optial coherent methods with the same device assistant with the same techinician'}], 'secondaryOutcomes': [{'measure': 'Refractive changes at the follow-up from the baseline (D)', 'timeFrame': '12-month', 'description': 'Spherical Equivalence were recorded with the right eyes only'}]}, 'oversightModule': {'oversightHasDmc': False, 'isFdaRegulatedDrug': False, 'isFdaRegulatedDevice': False}, 'conditionsModule': {'keywords': ['Myopia', 'PBM therapy', 'LLLT'], 'conditions': ['Myopia', 'Amblyopia', 'Refractive Error - Myopia Axial', 'Ametropia']}, 'referencesModule': {'references': [{'pmid': '36849626', 'type': 'BACKGROUND', 'citation': 'Zhou L, Tong L, Li Y, Williams BT, Qiu K. Photobiomodulation therapy retarded axial length growth in children with myopia: evidence from a 12-month randomized controlled trial evidence. Sci Rep. 2023 Feb 27;13(1):3321. doi: 10.1038/s41598-023-30500-7.'}]}, 'descriptionModule': {'briefSummary': "Photobiomodulation therapy, that is, Low-level red-light technology provides a new and innovative myopia control approach. This strategy enables relatively high energies of light to be delivered at much shorter durations of exposure to induce the myopia control effect. The efficacy of the low-level red-light technology has been proven in a Chinese populationb for the recent 3 years with evidence based papers and amazing results. However, there's not yet evidence to demonstrate the relationship between the dose response effect of photobiomodulation therapy on myopia control at the different age lever.", 'detailedDescription': 'Previous trial has demonstrated that 3-minutes per session twice a day repeated low-level red-light treatment at the irridiance of 2.3mW（2.0\\~2.5mW) controlled 87.7% of refraction progression and 76.8% of axial length elongation when the time of compliance to the treatment was 75%. Retrospective analyze other irriadance of 1.2mW, 0.6mW and 0.37mW culturally diverse groups will confirm and translate this technology into a solution for myopia control globally.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['CHILD', 'ADULT'], 'maximumAge': '41 Years', 'minimumAge': '4 Years', 'healthyVolunteers': True, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* Myopia or near Myopia with younger age\n* Without other intervention of myopia control, including atropine, Misight contact lens, special design lens to control myopia, orthokeratology and other red light devices.\n* Follow-up at least once\n* With baseline data of ocular parameters before the follow-up\n\nExclusion Criteria:\n\n* Photophobia\n* Allergy to red light\n* Severe ocular progressing diseases or systemic diseases\n* The data is unacceptable with reasonable explanations'}, 'identificationModule': {'nctId': 'NCT05957458', 'acronym': 'MCPT', 'briefTitle': 'Myopia Control With Three Lever Irradiance of PBM Therapy in Children and Adults', 'organization': {'class': 'INDUSTRY', 'fullName': 'Beijing Airdoc Technology Co., Ltd.'}, 'officialTitle': 'Retrospective Study of Photobiomodulation Therapy on Myopia Control With Airdoc Red Light at Wavelength of 650nm', 'orgStudyIdInfo': {'id': 'Airdoc MPC Co.Ltd.'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'EXPERIMENTAL', 'label': 'Moderate irradiance of PBM therapy to myopia', 'description': 'The PBM therapy irradiance is about 0.60mW. It is asked subjects to look at the light binocularly with fusion through the pupils with natural pupils. The distance between the light and the pupils is about 5\\~10cm. The treatment of each session is 3 minutes and twice daily administration while the interval time between two session is equal or larger than 4 hours with twice daily administration.', 'interventionNames': ['Device: Airdoc device of red light for Myopia']}, {'type': 'SHAM_COMPARATOR', 'label': 'Extra low irradiance PBM therapy group', 'description': 'The PBM therapy irradiance is about 0.37mW. It is asked subjects to look at the light binocularly with fusion through the pupils with natural pupils. The distance between the light and the pupils is about 5\\~10cm. The treatment of each session is 3 minutes and twice daily administration while the interval time between two session is equal or larger than 4 hours with twice daily administration.', 'interventionNames': ['Device: Airdoc device of red light for Myopia']}, {'type': 'EXPERIMENTAL', 'label': 'high lever PBM therapy group', 'description': 'The PBM therapy irradiance is about 1.20mW. It is asked subjects to look at the light binocularly with fusion through the pupils with natural pupils. The distance between the light and the pupils is about 5\\~10cm. The treatment of each session is 3 minutes and twice daily administration while the interval time between two session is equal or larger than 4 hours with twice daily administration.', 'interventionNames': ['Device: Airdoc device of red light for Myopia']}, {'type': 'NO_INTERVENTION', 'label': 'Control', 'description': 'Without PBM therapy group.'}], 'interventions': [{'name': 'Airdoc device of red light for Myopia', 'type': 'DEVICE', 'otherNames': ['low lever laser therapy', 'photobiomodulation therapy', 'low lever light therapy'], 'description': 'This light is Narrow-Band, Long-Wavelength Lighting with three different illumination (400lux, 800lux, 1200lux) or irridiance (1.2mW, 0.6mW, 0.37mW) respectively. And the wavelength is 650nm. It allows biocular therapy.', 'armGroupLabels': ['Extra low irradiance PBM therapy group', 'Moderate irradiance of PBM therapy to myopia', 'high lever PBM therapy group']}]}, 'contactsLocationsModule': {'locations': [{'zip': '100089', 'city': 'Beijing', 'state': 'Haidian District', 'country': 'China', 'facility': 'Qiu Jenny', 'geoPoint': {'lat': 39.9075, 'lon': 116.39723}}], 'overallOfficials': [{'name': 'QIU JENNY, MD', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': 'Airdoc MPC Co, Ltd.'}]}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Beijing Airdoc Technology Co., Ltd.', 'class': 'INDUSTRY'}, 'responsibleParty': {'type': 'SPONSOR'}}}}