Ignite Creation Date:
2025-12-24 @ 10:09 PM
Ignite Modification Date:
2025-12-25 @ 7:45 PM
Study NCT ID:
NCT05134935
Status:
ACTIVE_NOT_RECRUITING
Last Update Posted:
2025-12-05
First Post:
2021-11-15
Is NOT Gene Therapy:
False
Has Adverse Events:
False
Brief Title:
Defocus (DIMS) Spectacles Versus Ortho-K Lenses (OKL) for Slowing Myopia Progression in Children Aged 6-12 Years.
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'}]}, 'interventionBrowseModule': {'meshes': [{'id': 'D005139', 'term': 'Eyeglasses'}], 'ancestors': [{'id': 'D007909', 'term': 'Lenses'}, {'id': 'D055096', 'term': 'Optical Devices'}, {'id': 'D004864', 'term': 'Equipment and Supplies'}]}}, 'documentSection': {'largeDocumentModule': {'largeDocs': [{'date': '2025-11-24', 'size': 591821, 'label': 'Statistical Analysis Plan', 'hasIcf': False, 'hasSap': True, 'filename': 'SAP_001.pdf', 'typeAbbrev': 'SAP', 'uploadDate': '2025-11-24T04:35', 'hasProtocol': False}]}}, 'protocolSection': {'designModule': {'phases': ['NA'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'RANDOMIZED', 'maskingInfo': {'masking': 'NONE'}, 'primaryPurpose': 'TREATMENT', 'interventionModel': 'PARALLEL'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 90}}, 'statusModule': {'overallStatus': 'ACTIVE_NOT_RECRUITING', 'startDateStruct': {'date': '2022-06-29', 'type': 'ACTUAL'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2025-11', 'completionDateStruct': {'date': '2026-05', 'type': 'ESTIMATED'}, 'lastUpdateSubmitDate': '2025-11-27', 'studyFirstSubmitDate': '2021-11-15', 'studyFirstSubmitQcDate': '2021-11-15', 'lastUpdatePostDateStruct': {'date': '2025-12-05', 'type': 'ESTIMATED'}, 'studyFirstPostDateStruct': {'date': '2021-11-26', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2026-05', 'type': 'ESTIMATED'}}, 'outcomesModule': {'otherOutcomes': [{'measure': 'Choroidal thickness', 'timeFrame': 'During 18 months of therapy', 'description': 'Thickness is measured in um'}, {'measure': 'Pupil size', 'timeFrame': '6 months', 'description': 'Length in mm is measured 6 months after therapy'}, {'measure': 'Vision related quality of life using the questionnaire PREP2', 'timeFrame': 'Prior to and 9 months after treatment initiation', 'description': 'Range from "strongly disagree" to "strongly agree"'}], 'primaryOutcomes': [{'measure': 'Axial length growth of the eye', 'timeFrame': '18 months', 'description': 'Length in mm is measured 18 months after therapy'}], 'secondaryOutcomes': [{'measure': 'Overall eye length growth, defined as the sum of axial length and choroidal thickness', 'timeFrame': '18 months', 'description': 'Length in mm is measured 18 months after therapy'}]}, 'oversightModule': {'isFdaRegulatedDrug': False, 'isFdaRegulatedDevice': False}, 'conditionsModule': {'conditions': ['Myopia']}, 'descriptionModule': {'briefSummary': 'The goal of this non-inferiority randomized clinical trial is to compare the myopia control efficacy of Ortho-K lenses (OKL) and Defocus (DIMS) spectacles in myopic children aged 6-12 years. The main question it aims to answer is:\n\n\\- Is the DIMS spectacle lens not worse than the OKL after 18 months of therapy?\n\nThe participants are randomly assigned to either OKL or DIMS spectacles and followed during 18 months of therapy.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['CHILD'], 'maximumAge': '12 Years', 'minimumAge': '6 Years', 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion criteria:\n\n\\- Myopic children aged 6 to 12 years: Myopia of the 6 to 8-year-olds (inclusive): -1.00 to -4.75 D spherical component and up to -2.50 D of regular astigmatism (both eyes).\n\nMyopia of the 9 to 12-year-olds (inclusive): -2.00 to -4.75 D spherical component and up to -2.50 D of regular astigmatism (both eyes).\n\n* Anisometropia ≤ 1.50 D cycloplegic spherical equivalent refractive error.\n* Best corrected visual acuity at age 6 to 12 years (inclusive): 0.8 Snellen (equivalent to ≥ 3/5 letter on the 0.8 line = 78 ETDRS letters)\n\nExclusion criteria:\n\n* Manifest or intermittent squint.\n* Contraindications to the use of OKL comprising (not exhaustive): keratoconus, chronic allergic conjunctivitis and keratoconjunctivitis sicca.\n* Previous eye surgery.\n* Chronic eye disease demanding daily use of eye drops.\n* Non-compliance to eye examinations (unstable fixation or anxiety towards contact lenses).\n* Previous myopia control treatment.'}, 'identificationModule': {'nctId': 'NCT05134935', 'acronym': 'NISDO', 'briefTitle': 'Defocus (DIMS) Spectacles Versus Ortho-K Lenses (OKL) for Slowing Myopia Progression in Children Aged 6-12 Years.', 'organization': {'class': 'OTHER', 'fullName': 'Vejle Hospital'}, 'officialTitle': 'Defocus Incorporated Multiple Segment (DIMS) Spectacle Lenses Versus Orthokeratology Lenses (OKL) for Slowing Myopia Progression In Children Aged 6-12 Years. A Non-inferiority Randomized Clinical Trial. The NISDO Study.', 'orgStudyIdInfo': {'id': 'NISDO'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'ACTIVE_COMPARATOR', 'label': 'OKL', 'interventionNames': ['Device: Orthokerathology lenses (OKL)']}, {'type': 'EXPERIMENTAL', 'label': 'DIMS', 'interventionNames': ['Device: Defocus Incorporated Multiple Segment (DIMS) Spectacles']}], 'interventions': [{'name': 'Defocus Incorporated Multiple Segment (DIMS) Spectacles', 'type': 'DEVICE', 'otherNames': ['Defocus (DIMS) Spectacles'], 'description': '18 months of therapy.', 'armGroupLabels': ['DIMS']}, {'name': 'Orthokerathology lenses (OKL)', 'type': 'DEVICE', 'otherNames': ['Night lenses'], 'description': '18 months of therapy.', 'armGroupLabels': ['OKL']}]}, 'contactsLocationsModule': {'locations': [{'zip': '7100', 'city': 'Vejle', 'state': 'Southern Denmark', 'country': 'Denmark', 'facility': 'The Ophthalmic department, Vejle Hospital', 'geoPoint': {'lat': 55.70927, 'lon': 9.5357}}], 'overallOfficials': [{'name': 'Lou-Ann Andersen', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': 'Vejle Hospital'}]}, 'ipdSharingStatementModule': {'ipdSharing': 'NO'}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Vejle Hospital', 'class': 'OTHER'}, 'responsibleParty': {'type': 'SPONSOR'}}}}