Ignite Creation Date:
2025-12-24 @ 11:29 PM
Ignite Modification Date:
2025-12-25 @ 9:16 PM
Study NCT ID:
NCT06926556
Status:
COMPLETED
Last Update Posted:
2025-04-13
First Post:
2024-09-28
Is NOT Gene Therapy:
False
Has Adverse Events:
False
Brief Title:
Different Microlenses Array for Controlling Myopia Progression in Children and Adolescents
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}}, 'protocolSection': {'designModule': {'phases': ['NA'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'RANDOMIZED', 'maskingInfo': {'masking': 'TRIPLE', 'whoMasked': ['PARTICIPANT', 'CARE_PROVIDER', 'INVESTIGATOR']}, 'primaryPurpose': 'PREVENTION', 'interventionModel': 'PARALLEL'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 134}}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '2024-08-01', 'type': 'ACTUAL'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2025-04', 'completionDateStruct': {'date': '2024-12-31', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2025-04-07', 'studyFirstSubmitDate': '2024-09-28', 'studyFirstSubmitQcDate': '2025-04-07', 'lastUpdatePostDateStruct': {'date': '2025-04-13', 'type': 'ACTUAL'}, 'studyFirstPostDateStruct': {'date': '2025-04-13', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2024-10-31', 'type': 'ACTUAL'}}, 'outcomesModule': {'otherOutcomes': [{'measure': 'Other biological parameters', 'timeFrame': '2 years', 'description': 'amplitude of accommodation, anterior chamber depth, corneal curvature, white to white distance, central corneal thickness, lens thickness ,pupil size, multispectral refraction topography, choroidal thickness, objective visual quality, wavefront aberration, contrast sensitivity, and strabismus (mahalanobis bar method).'}, {'measure': 'Best corrected visual acuity', 'timeFrame': '2 years'}, {'measure': 'questionnaires of daily eye habits and wearing time of subjects collected', 'timeFrame': '2 years'}], 'primaryOutcomes': [{'measure': 'Subjective refraction equivalent spherical', 'timeFrame': '2 years'}], 'secondaryOutcomes': [{'measure': 'Axial length', 'timeFrame': '2 years'}]}, 'oversightModule': {'isUsExport': False, 'oversightHasDmc': False, 'isFdaRegulatedDrug': False, 'isFdaRegulatedDevice': False}, 'conditionsModule': {'conditions': ['Myopia Progressing']}, 'descriptionModule': {'briefSummary': 'This study aims to evaluate the effectiveness of lenses with different defocused microlens array in controlling the progression of myopia in children and adolescents, and to explore the feasibility of effective defocus microlens design, and apply personalized defocus frame lenses for myopia prevention and control.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['CHILD'], 'maximumAge': '14 Years', 'minimumAge': '6 Years', 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria:\n\n1. Age: 6-14 years old;\n2. After using 1% cyclohexanone hydrochloride eye drops (Saifeijie) for ciliary muscle paralysis, binocular spherical power were within -0.50D\\~-4.00D, binocular cylinder power ≤ 1.50D, the anisometropia is less than 1.50D, and the best corrected visual acuity was above 5.0;\n3. Within 30 days, the myopia prevention and control methods such as multifocal glasses, orthokeratology, defocusing flexible glasses, progressive glasses, atropine eye drops, red light and acupuncture and moxibustion treatment were not used;\n4. The subject has a willingness to receive treatment and an informed consent form is signed by their legal guardian.\n\nExclusion Criteria:\n\n1. Diagnosed constant strabismus;\n2. Diagnosed pathological myopia;\n3. Other congenital eye diseases;\n4. Researchers believe that the patients have other reasons that are not suitable for inclusion in the project.'}, 'identificationModule': {'nctId': 'NCT06926556', 'briefTitle': 'Different Microlenses Array for Controlling Myopia Progression in Children and Adolescents', 'organization': {'class': 'OTHER', 'fullName': 'Shanghai Eye Disease Prevention and Treatment Center'}, 'officialTitle': 'Different Microlenses Array for Controlling Myopia Progression in Children and Adolescents', 'orgStudyIdInfo': {'id': 'QX-2024-A-003'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'EXPERIMENTAL', 'label': 'H.M.E.C，High Precision Micro Encircle', 'interventionNames': ['Device: Defocus microlenses']}, {'type': 'ACTIVE_COMPARATOR', 'label': 'H. A. L. T, highly aspheric lenslet technology'}], 'interventions': [{'name': 'Defocus microlenses', 'type': 'DEVICE', 'description': 'Different microlenses array (H.M.E.C，High Precision Micro Encircle and H.A.L.T, highly aspheric lenslet technology) for controlling myopia progression in children and adolescents.', 'armGroupLabels': ['H.M.E.C，High Precision Micro Encircle']}]}, 'contactsLocationsModule': {'locations': [{'zip': '200050', 'city': 'Shanghai', 'state': 'Shanghai Municipality', 'country': 'China', 'facility': 'Shanghai Eye Diseases Prevention &Treatment Center/ Shanghai Eye Hospital, School of Medicine, Tongji University', 'geoPoint': {'lat': 31.22222, 'lon': 121.45806}}]}, 'ipdSharingStatementModule': {'ipdSharing': 'UNDECIDED'}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Shanghai Eye Disease Prevention and Treatment Center', 'class': 'OTHER'}, 'responsibleParty': {'type': 'SPONSOR'}}}}