Ignite Creation Date:
2025-12-24 @ 3:07 PM
Ignite Modification Date:
2025-12-26 @ 11:08 PM
Study NCT ID:
NCT05090592
Status:
UNKNOWN
Last Update Posted:
2021-10-25
First Post:
2021-09-07
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Influence of Corneal Biomechanical Properties on Myopia Control
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': {'studyType': 'OBSERVATIONAL', 'designInfo': {'timePerspective': 'PROSPECTIVE', 'observationalModel': 'CASE_ONLY'}, 'enrollmentInfo': {'type': 'ESTIMATED', 'count': 100}, 'patientRegistry': False}, 'statusModule': {'overallStatus': 'UNKNOWN', 'lastKnownStatus': 'ENROLLING_BY_INVITATION', 'startDateStruct': {'date': '2021-01-01', 'type': 'ACTUAL'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2021-09', 'completionDateStruct': {'date': '2022-12-31', 'type': 'ESTIMATED'}, 'lastUpdateSubmitDate': '2021-10-11', 'studyFirstSubmitDate': '2021-09-07', 'studyFirstSubmitQcDate': '2021-10-11', 'lastUpdatePostDateStruct': {'date': '2021-10-25', 'type': 'ACTUAL'}, 'studyFirstPostDateStruct': {'date': '2021-10-25', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2022-07-30', 'type': 'ESTIMATED'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'changes of the intraocular pressure in myopic children with different treatment', 'timeFrame': 'from the date of starting treatment, the IOP was measured 1 week, 1month and every 3 months up to 24 months.', 'description': 'the investigators measure the intraocular pressure(IOP, mmHg) of myopic children with different treatment (low concentration atropine eye drops and orthokeratology)'}, {'measure': 'changes of the visual acuity in myopic children with different treatment', 'timeFrame': 'from the date of starting treatment, the visual acuity was measured 1 week, 1month and every 3 months up to 24 months.', 'description': 'the investigators measure the visual acuity of myopic children with different treatment (low concentration atropine eye drops and orthokeratology).'}, {'measure': 'changes of the central corneal thickness in myopic children with different treatment', 'timeFrame': 'from the date of starting treatment, the central corneal thickness was measured 1 week, 1month and every 3 months up to 24 months.', 'description': 'the the investigators measure the central corneal thickness(CCT, micrometer, ㎛) of myopic children with different treatment (low concentration atropine eye drops and orthokeratology) by Corvis ST machine'}, {'measure': 'changes of the corneal biomechanics index in myopic children with different treatment', 'timeFrame': 'from the date of starting treatment, the corneal biomechanics index was measured 1 week, 1month and every 3 months up to 24 months.', 'description': 'the the investigators measure the corneal biomechanics index (CBI) of myopic children with different treatment (low concentration atropine eye drops and orthokeratology) by Corvis ST machine'}, {'measure': 'changes of the stress-strain index in myopic children with different treatment', 'timeFrame': 'from the date of starting treatment, the stress-strain index (SSI) was measured 1 week, 1month and every 3 months up to 24 months.', 'description': 'the the investigators measure the stress-strain index (SSI) of myopic children with different treatment (low concentration atropine eye drops and orthokeratology) by Corvis ST machine'}], 'secondaryOutcomes': [{'measure': 'changes of axial length in myopic children with different treatment', 'timeFrame': 'from the date of starting treatment, the axial length was measured, then repeat measure were performed every 6 months up to 24 months', 'description': 'the investigators measure the axial length(mm) of eyeball of myopic children with different treatment (low concentration atropine eye drops and orthokeratology).'}]}, 'oversightModule': {'oversightHasDmc': True, 'isFdaRegulatedDrug': True, 'isFdaRegulatedDevice': True}, 'conditionsModule': {'conditions': ['Myopia']}, 'descriptionModule': {'briefSummary': 'to analyze the changes in corneal biomechanics of myopic children with different treatment (low concentration atropine eye drops and orthokeratology) and explore the possible mechanism of myopia control', 'detailedDescription': 'High myopia is accompanied by excessive growth of eyeball, which leads to many complications. Myopia control is a great concern of the government and ophthalmologists worldwide.\n\nAtropine eye drops is used clinically to control the progression of myopia. In recent years, low dose Atropine eye drops (0.01%, 0.05% and 0.1%) have been proven to be effective in slowing growth of eyeball. With less negative effects, these eye drops have been widely used for school children in Taiwan. Orthokeratology is another effective tool to control myopia, and long-term wearing of Ortho-k lens can inhibit the speed of eyeball growth, it is the most useful optical treatment for myopia control.\n\nThe Corvis® ST is a combination of an air pulse tonometer with an ultra-high-speed Scheimpflug camera. The movement of the cornea is mainly influenced by three factors which can be measured by the instrument:\n\nIntraocular pressure (IOP)，biomechanical properties of the cornea and corneal thickness. The relationship between adult corneal biomechanics and refractive error has been noted in recent years. Previous studies pointed out that corneal biomechanics analyzer (Corvis ST) can measure the deformation process of the cornea and the biomechanics parameters. These literature found that the corneas of myopic patients， esp. high myopic, have larger corneal deformation in biomechanics analysis and revealed that the corneal stiffness of myopia patients was lower. There are still few discussions about the effect of orthokeratology on corneal biomechanics and there is no research focused on the change of corneal biomechanics of low-concentration atropine user which is worthy of our further exploration.\n\nIn this study, the investigators hope to analyze the changes in corneal biomechanics of myopic children with different treatment (low concentration atropine eye drops and orthokeratology) and explore the possible mechanism of myopia control.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['CHILD', 'ADULT'], 'maximumAge': '20 Years', 'minimumAge': '8 Years', 'samplingMethod': 'PROBABILITY_SAMPLE', 'studyPopulation': 'We enroll the clinical patient who recieved orthokeratology or 0.01% atropine for myopia control. Age limits was 8 to 20 year-old. The purpose and process were carefully addressed to the subjects and their guardians who signed an informed consent form before commencing this study.', 'healthyVolunteers': True, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* myopia (\\<-1D)\n* received Orthokeratology or 0.01% atropine for myopia control\n* regular follow-up\n\nExclusion Criteria:\n\n* ocular surface disease( dry eye, keratoconus..)\n* allergy to orthokeratology or atropine\n* received eye surgery\n\n * strabismus\n * premature birth'}, 'identificationModule': {'nctId': 'NCT05090592', 'briefTitle': 'Influence of Corneal Biomechanical Properties on Myopia Control', 'organization': {'class': 'OTHER', 'fullName': 'Buddhist Tzu Chi General Hospital'}, 'officialTitle': 'Influence of Corneal Biomechanical Properties on Myopia Reduction and Axial Elongation in Children Using Orthokeratology and 0.01% Atropine', 'orgStudyIdInfo': {'id': 'Buddhist TCGH'}}, 'armsInterventionsModule': {'armGroups': [{'label': 'myopic children', 'description': 'Myopic children use overnight orthokeratology or 0.01% atropine eye drop per night for myopia control', 'interventionNames': ['Device: orthokeratology', 'Drug: 0.01 atropine']}], 'interventions': [{'name': 'orthokeratology', 'type': 'DEVICE', 'description': 'orthokeratology wearing for myopia control', 'armGroupLabels': ['myopic children']}, {'name': '0.01 atropine', 'type': 'DRUG', 'description': '0.01% atropine eye drop prevent myopic progression', 'armGroupLabels': ['myopic children']}]}, 'contactsLocationsModule': {'locations': [{'zip': '265', 'city': 'Yilan', 'state': 'Ilan County', 'country': 'Taiwan', 'facility': 'Yu-Teng Lai', 'geoPoint': {'lat': 24.757, 'lon': 121.753}}], 'overallOfficials': [{'name': 'Cheng-Jen Chiu, Doctor', 'role': 'STUDY_DIRECTOR', 'affiliation': 'Tzu Chi genral hospital'}]}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Buddhist Tzu Chi General Hospital', 'class': 'OTHER'}, 'responsibleParty': {'type': 'SPONSOR'}}}}