Ignite Creation Date:
2025-12-24 @ 9:55 PM
Ignite Modification Date:
2026-01-01 @ 6:13 PM
Study NCT ID:
NCT05594732
Status:
COMPLETED
Last Update Posted:
2023-06-08
First Post:
2022-10-01
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
The Effects of Different Outdoor Light Exposure Modes on Retinal Blood Flow
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'], 'maskingDescription': 'The participants were randomly divided into two groups without knowing the exposing mode.'}, 'primaryPurpose': 'PREVENTION', 'interventionModel': 'PARALLEL', 'interventionModelDescription': 'The participants were randomly divided into the following two groups:\n\n1. 4000Lux natural light exposure;\n2. 10000Lux natural light exposure.'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 81}}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '2022-09-06', 'type': 'ACTUAL'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2022-10', 'completionDateStruct': {'date': '2022-10-30', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2023-06-07', 'studyFirstSubmitDate': '2022-10-01', 'studyFirstSubmitQcDate': '2022-10-25', 'lastUpdatePostDateStruct': {'date': '2023-06-08', 'type': 'ACTUAL'}, 'studyFirstPostDateStruct': {'date': '2022-10-26', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2022-10-30', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Retinal blood flow density after relaxing for 15 minutes', 'timeFrame': 'Exposing to sunlight for 15 minutes', 'description': 'Data collected from Optovue AngioVue OCT (macular blood data collected) for the dominant eye. The duration of relaxing was recorded by a timer.'}], 'secondaryOutcomes': [{'measure': 'Retinal blood flow density changes between relaxing for 5 and 15 minutes', 'timeFrame': 'Retinal blood flow density after relaxing for 5 and 15 minutes', 'description': 'The difference in retinal blood flow density was calculated between 5 and 15 minutes.'}]}, 'oversightModule': {'oversightHasDmc': False, 'isFdaRegulatedDrug': False, 'isFdaRegulatedDevice': False}, 'conditionsModule': {'keywords': ['myopia', 'retinal blood flow', 'accommodative micro-fluctuation', 'outdoor light exposure'], 'conditions': ['Myopia']}, 'referencesModule': {'references': [{'pmid': '34473223', 'type': 'BACKGROUND', 'citation': 'Mirhajianmoghadam H, Pina A, Ostrin LA. Objective and Subjective Behavioral Measures in Myopic and Non-Myopic Children During the COVID-19 Pandemic. Transl Vis Sci Technol. 2021 Sep 1;10(11):4. doi: 10.1167/tvst.10.11.4.'}, {'pmid': '31018118', 'type': 'BACKGROUND', 'citation': 'Rucker F. Monochromatic and white light and the regulation of eye growth. Exp Eye Res. 2019 Jul;184:172-182. doi: 10.1016/j.exer.2019.04.020. Epub 2019 Apr 21.'}, {'pmid': '28251836', 'type': 'BACKGROUND', 'citation': 'Xiong S, Sankaridurg P, Naduvilath T, Zang J, Zou H, Zhu J, Lv M, He X, Xu X. Time spent in outdoor activities in relation to myopia prevention and control: a meta-analysis and systematic review. Acta Ophthalmol. 2017 Sep;95(6):551-566. doi: 10.1111/aos.13403. Epub 2017 Mar 2.'}, {'pmid': '33550704', 'type': 'BACKGROUND', 'citation': 'Liu Y, Wang L, Xu Y, Pang Z, Mu G. The influence of the choroid on the onset and development of myopia: from perspectives of choroidal thickness and blood flow. Acta Ophthalmol. 2021 Nov;99(7):730-738. doi: 10.1111/aos.14773. Epub 2021 Feb 7.'}, {'pmid': '38981665', 'type': 'DERIVED', 'citation': 'Zhao L, Zhang B, Wang J, Yang J, Du L, Wang T, Xu X, He X, Chen J. Short-term effects of sunlight exposure on fundus blood flow perfusion in children: a randomised controlled trial. Br J Ophthalmol. 2024 Dec 17;109(1):139-145. doi: 10.1136/bjo-2024-325715.'}]}, 'descriptionModule': {'briefSummary': "In 2020, the overall myopia rate among children and adolescents in my country was 52.7%. The COVID-19 pandemic has increased students' time of indoor eye-using, and it showed that the light exposure intensity of myopic students is lower than that of non-myopia students. Studies have found that the light wave bandwidth has a significant impact on the emmetropization of the eye, and white light can promote emmetropia more than monochromatic light. It shows that outdoor exercise has a protective effect on the occurrence and development of myopia in children and adolescents, but the specific mechanism is still unclear. Retinal blood flow is sensitive to myopic stimuli, and is a short-term indicator of the relationship between light environment and myopia. This study selected retinal blood flow as the primary outcome, aiming to compare the effects of different outdoor light exposure modes on retinal blood flow after 1 hour of intense eye use, and provide clues for the prevention and control of myopia.", 'detailedDescription': "In 2018, eight departments including the Ministry of Education jointly issued the Implementation Plan for Comprehensive Prevention and Control of Myopia in Children and Adolescents. As of 2020, the overall myopia rate among children and adolescents in my country was 52.7%. The COVID-19 pandemic has increased students' time of indoor eye-using, and it showed that the light exposure intensity of myopic students is lower than that of non-myopia students. Studies have found that the light wave bandwidth has a significant impact on the emmetropization of the eye, and white light can promote emmetropia more than monochromatic light. It shows that outdoor exercise has a protective effect on the occurrence and development of myopia in children and adolescents, but the specific mechanism is still unclear. Retinal blood flow is sensitive to myopic stimuli, and is a short-term indicator of the relationship between light environment and myopia. Also, there is a theory that reduced choroidal blood flow causes scleral hypoxia, which leads to the development of myopia. Therefore, this study selected retinal blood flow as the primary outcome, aiming to compare the effects of different outdoor light exposure modes on retinal blood flow after 1 hour of intense eye use, and provide clues for the prevention and control of myopia."}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['CHILD'], 'maximumAge': '15 Years', 'minimumAge': '7 Years', 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* School students aged from 7 to 15, regardless of sex or gender;\n* Diopter between -2.0D and 3.0D, and astigmatism not exceed 0.75D;\n* No organic disease and in good general condition;\n* Have obtained the consent of their parents or guardians, and can cooperate.\n\nExclusion Criteria:\n\n* Suffering from amblyopia, strabismus, color weakness, congenital cataract, glaucoma and other eye diseases;\n* Other circumstances judged by the investigator to be unsuitable to participate in the research.'}, 'identificationModule': {'nctId': 'NCT05594732', 'briefTitle': 'The Effects of Different Outdoor Light Exposure Modes on Retinal Blood Flow', 'organization': {'class': 'OTHER', 'fullName': 'Shanghai Eye Disease Prevention and Treatment Center'}, 'officialTitle': 'The Effects of Different Outdoor Light Exposure Modes on Retinal Blood Flow in School Students: a Randomized Controlled Trial', 'orgStudyIdInfo': {'id': 'YFZXLDX20220802'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'EXPERIMENTAL', 'label': 'Weak outdoor light', 'description': '4000Lux natural light exposure', 'interventionNames': ['Behavioral: Weak outdoor light']}, {'type': 'EXPERIMENTAL', 'label': 'Strong outdoor light', 'description': '10000Lux natural light exposure', 'interventionNames': ['Behavioral: Strong outdoor light']}], 'interventions': [{'name': 'Weak outdoor light', 'type': 'BEHAVIORAL', 'description': 'Stay and stare far on the balcony or under the tree', 'armGroupLabels': ['Weak outdoor light']}, {'name': 'Strong outdoor light', 'type': 'BEHAVIORAL', 'description': 'Stay and stare far in the sunlight', 'armGroupLabels': ['Strong outdoor light']}]}, 'contactsLocationsModule': {'locations': [{'zip': '200041', 'city': 'Shanghai', 'state': 'Shanghai Municipality', 'country': 'China', 'facility': 'Shanghai Eye Disease Prevention and Treatment Center', 'geoPoint': {'lat': 31.22222, 'lon': 121.45806}}], 'overallOfficials': [{'name': 'Xiangui He', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': 'Shanghai Eye Hospital'}]}, 'ipdSharingStatementModule': {'ipdSharing': 'NO'}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Shanghai Eye Disease Prevention and Treatment Center', 'class': 'OTHER'}, 'responsibleParty': {'type': 'SPONSOR'}}}}