Ignite Creation Date:
2025-12-25 @ 12:38 AM
Ignite Modification Date:
2025-12-31 @ 8:06 PM
Study NCT ID:
NCT03294967
Status:
COMPLETED
Last Update Posted:
2020-07-29
First Post:
2017-09-20
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Effect of Caffeine on Ocular Circulation in High Myopes
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'interventionBrowseModule': {'meshes': [{'id': 'D002110', 'term': 'Caffeine'}, {'id': 'D014810', 'term': 'Vitamin E'}], 'ancestors': [{'id': 'D014970', 'term': 'Xanthines'}, {'id': 'D000470', 'term': 'Alkaloids'}, {'id': 'D006571', 'term': 'Heterocyclic Compounds'}, {'id': 'D011688', 'term': 'Purinones'}, {'id': 'D011687', 'term': 'Purines'}, {'id': 'D006574', 'term': 'Heterocyclic Compounds, 2-Ring'}, {'id': 'D000072471', 'term': 'Heterocyclic Compounds, Fused-Ring'}, {'id': 'D001578', 'term': 'Benzopyrans'}, {'id': 'D011714', 'term': 'Pyrans'}, {'id': 'D006573', 'term': 'Heterocyclic Compounds, 1-Ring'}]}}, 'protocolSection': {'designModule': {'phases': ['NA'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'RANDOMIZED', 'maskingInfo': {'masking': 'SINGLE', 'whoMasked': ['PARTICIPANT'], 'maskingDescription': 'Participants will not see the label of the capsule.'}, 'primaryPurpose': 'DIAGNOSTIC', 'interventionModel': 'CROSSOVER', 'interventionModelDescription': 'This will be a crossover study. Each subject is required to consume 200mg caffeine capsule and 200IU vitamin E control capsule, as control, in two different visits. The two visits will be randomized, with a washout period of at least one week.'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 18}}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '2017-09-01', 'type': 'ACTUAL'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2020-07', 'completionDateStruct': {'date': '2019-12-31', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2020-07-27', 'studyFirstSubmitDate': '2017-09-20', 'studyFirstSubmitQcDate': '2017-09-22', 'lastUpdatePostDateStruct': {'date': '2020-07-29', 'type': 'ACTUAL'}, 'studyFirstPostDateStruct': {'date': '2017-09-27', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2019-12-31', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Choroidal thickness', 'timeFrame': 'Within 4 hours', 'description': 'Choroidal thickness measured by the optical coherence tomography'}], 'secondaryOutcomes': [{'measure': 'Retinal vessel density', 'timeFrame': 'Within 4 hours', 'description': 'Superficial retinal vessel density measured by OCTA'}]}, 'oversightModule': {'oversightHasDmc': True, 'isFdaRegulatedDrug': False, 'isFdaRegulatedDevice': False}, 'conditionsModule': {'keywords': ['High Myopia', 'Caffeine', 'Choroidal Thickness', 'Choroidal Volume', 'Optical Coherence Tomography', 'Optical Coherence Tomography Angiography'], 'conditions': ['High Myopia', 'Choroid']}, 'descriptionModule': {'briefSummary': 'To investigate the effect of caffeine on ocular circulation by using Optical Coherence Tomography and Optical Coherence Tomography Angiography. This study will evaluate blood supply to the inner and outer retina after consumption of 200mg caffeine capsule, in particular its effect in high myopes.', 'detailedDescription': 'Caffeine could cause vasoconstriction. Previous studies revealed a reduction of retinal blood vessels diameter, a decrease in macular blood flow, and a decrease in blood velocity of optic nerve. Research devices, such as laser speckle tissue circulation analyzer and blue field simulation technique, were used in previous studies.\n\nWith an advancement of technology such as optical coherence tomography (OCT), choroidal thickness can be measured, which indicates blood supply to outer retina. In addition, superficial retinal vasculature can be measured using optical coherence tomography angiography (OCTA).\n\nPrevious studies found that subfoveal choroidal thickness declined with increase in myopia. A negative association between subfoveal choroidal thickness and axial length was also found. A recent study found a negative association between retinal vessel density with axial length in Chinese myopes using OCTA. Therefore, caffeine consumption may further make high myopes prone to ocular diseases development due to poor ocular circulation.\n\nThe current study will use OCTA to measure the superficial retinal vasculature and OCT to measure choroidal thickness and choroidal volume of high myopes after consumption of caffeine capsule.\n\nStatistical analysis\n\nNormality of data will be assessed. The effect of caffeine on choroidal thickness, choroidal volume, vessel density, and perfusion density of superficial retinal layers will be analysed using repeated-measures ANOVA (co-variates) to compare baseline data and that after caffeine consumption at various time points. If significant difference is obtained, post hoc tests will be conducted to compare results from various time points with the baseline data. Difference between different age groups will be compared using unpaired t-test or Mann Whitney test, as appropriate.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT'], 'maximumAge': '49 Years', 'minimumAge': '20 Years', 'healthyVolunteers': True, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* Refractive error should be at least -6 Diopters or lower (spherical equivalent)\n* Best corrected visual acuity of at least 6/6\n* Non-smoker\n\nExclusion Criteria:\n\n\\- Diagnosed with any ocular diseases and systemic diseases'}, 'identificationModule': {'nctId': 'NCT03294967', 'briefTitle': 'Effect of Caffeine on Ocular Circulation in High Myopes', 'organization': {'class': 'OTHER', 'fullName': 'The Hong Kong Polytechnic University'}, 'officialTitle': 'Effect of Caffeine on Ocular Circulation in High Myopes', 'orgStudyIdInfo': {'id': 'HSEARS20170613002'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'ACTIVE_COMPARATOR', 'label': 'Caffeine', 'description': 'To determine the effect of caffeine on ocular circulation in high myopes by consuming 200 mg caffeine capsule', 'interventionNames': ['Dietary Supplement: Caffeine']}, {'type': 'PLACEBO_COMPARATOR', 'label': 'Vitamin E', 'description': 'To determine the effect of caffeine on ocular circulation in high myopes by consuming and 200 International Unit vitamin E control capsule, as control', 'interventionNames': ['Dietary Supplement: Vitamin E']}], 'interventions': [{'name': 'Caffeine', 'type': 'DIETARY_SUPPLEMENT', 'description': 'As in group descriptions', 'armGroupLabels': ['Caffeine']}, {'name': 'Vitamin E', 'type': 'DIETARY_SUPPLEMENT', 'description': 'As in group descriptions', 'armGroupLabels': ['Vitamin E']}]}, 'contactsLocationsModule': {'locations': [{'city': 'Hong Kong', 'country': 'Hong Kong', 'facility': 'School of optometry', 'geoPoint': {'lat': 22.27832, 'lon': 114.17469}}], 'overallOfficials': [{'name': 'Kwok Cheung Andrew Lam, PhD', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': 'The Hong Kong Polytechinc University'}]}, 'ipdSharingStatementModule': {'ipdSharing': 'NO'}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'The Hong Kong Polytechnic University', 'class': 'OTHER'}, 'responsibleParty': {'type': 'PRINCIPAL_INVESTIGATOR', 'investigatorTitle': 'Associate Professor', 'investigatorFullName': 'Dr Andrew KC Lam', 'investigatorAffiliation': 'The Hong Kong Polytechnic University'}}}}