Ignite Creation Date:
2025-12-25 @ 3:28 AM
Ignite Modification Date:
2025-12-26 @ 2:09 AM
Study NCT ID:
NCT05888805
Status:
RECRUITING
Last Update Posted:
2025-09-22
First Post:
2023-05-24
Is NOT Gene Therapy:
False
Has Adverse Events:
False
Brief Title:
Myopia Control Efficacy of Second-generation DIMS Spectacle Lenses on Fast Progressing Myopes - Auxiliary Group
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': 'NA', 'maskingInfo': {'masking': 'NONE'}, 'primaryPurpose': 'TREATMENT', 'interventionModel': 'SINGLE_GROUP', 'interventionModelDescription': 'Participants will be prescribed with a pair of DIMS spectacle lenses for 24 months.'}, 'enrollmentInfo': {'type': 'ESTIMATED', 'count': 59}}, 'statusModule': {'overallStatus': 'RECRUITING', 'startDateStruct': {'date': '2023-07-29', 'type': 'ACTUAL'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2024-10', 'completionDateStruct': {'date': '2026-05-31', 'type': 'ESTIMATED'}, 'lastUpdateSubmitDate': '2025-09-19', 'studyFirstSubmitDate': '2023-05-24', 'studyFirstSubmitQcDate': '2023-05-24', 'lastUpdatePostDateStruct': {'date': '2025-09-22', 'type': 'ESTIMATED'}, 'studyFirstPostDateStruct': {'date': '2023-06-05', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2026-02-28', 'type': 'ESTIMATED'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Cycloplegic refraction change in spherical equivalent refraction (SER)', 'timeFrame': 'Baseline, 1st year and 2nd year', 'description': 'Cycloplegic SER (in diopter) will be measured using an open field autorefractor.\n\nChange in SER with cycloplegia from the baseline over a first 12-month period and a 12-month period of follow-up will be measured.'}], 'secondaryOutcomes': [{'measure': 'Axial length change', 'timeFrame': 'Baseline, 1st year and 2nd year', 'description': 'Axial length (mm) will be measured after cycloplegia using a non-contact optical biometer.\n\nChange in axial length from the baseline over a first 12-month period and a 12-month period of follow-up will be measured.'}]}, 'oversightModule': {'isUsExport': False, 'oversightHasDmc': True, 'isFdaRegulatedDrug': False, 'isFdaRegulatedDevice': False}, 'conditionsModule': {'keywords': ['Myopia', 'Defocus'], 'conditions': ['Myopia']}, 'referencesModule': {'references': [{'pmid': '41171741', 'type': 'DERIVED', 'citation': 'Hon Y, Chun RKM, Leung TW, Qi H, Hasegawa K, Leung KY, To CH, Lam CSY, Tse DY. Myopia control efficacy of second-generation defocus incorporated multiple segments spectacle lenses on fast progressing myopes: Study protocol of a randomised controlled trial. PLoS One. 2025 Oct 31;20(10):e0335061. doi: 10.1371/journal.pone.0335061. eCollection 2025.'}]}, 'descriptionModule': {'briefSummary': 'The purpose of this study is to examine the efficacy and performance of the Defocus Incorporated Multiple Segments (DIMS) Spectacle lenses on controlling myopia progression in fast progressing myopic children.', 'detailedDescription': 'DIMS spectacle lens is a multifocal spectacle lens that produces myopic defocus images and corrects distance refractive errors at the same time.\n\nParticipants will be prescribed a pair of DIMS spectacle lenses. Their cycloplegic refraction and axial length will be monitored every 6 months over 2 years.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['CHILD'], 'maximumAge': '12 Years', 'minimumAge': '4 Years', 'healthyVolunteers': True, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* SER: -1.00D or below\n* Documented history of fast progressing myopia, either in SER or AL\n* SER progression: 0.50D/year or more\n* AL elongation: 0.27mm/year or more\n* Best-corrected monocular visual acuity (VA) in both eyes: 0.00 logMAR (equivalent) or better\n* Acceptance of random group allocation and the masked study design\n* Anisometropia of 1.50 D or less\n* Astigmatism of 2.00 D or less\n\nExclusion Criteria:\n\n* Strabismus and binocular vision abnormalities\n* Ocular and systemic abnormalities\n* Prior experience of myopia control'}, 'identificationModule': {'nctId': 'NCT05888805', 'briefTitle': 'Myopia Control Efficacy of Second-generation DIMS Spectacle Lenses on Fast Progressing Myopes - Auxiliary Group', 'organization': {'class': 'OTHER', 'fullName': 'The Hong Kong Polytechnic University'}, 'officialTitle': 'Myopia Control Efficacy of Second-generation DIMS Spectacle Lenses on Fast Progressing Myopes - Auxiliary Group', 'orgStudyIdInfo': {'id': 'P0043588'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'OTHER', 'label': 'DIMS lens group', 'description': 'Participants will be prescribed with a pair of DIMS spectacle lenses for 24 months.', 'interventionNames': ['Other: DIMS spectacle lens']}], 'interventions': [{'name': 'DIMS spectacle lens', 'type': 'OTHER', 'otherNames': ['MiYOSMART'], 'description': 'DIMS spectacle lens is a multifocal spectacle lens that corrects the distance refraction and provides myopic defocus simultaneously.', 'armGroupLabels': ['DIMS lens group']}]}, 'contactsLocationsModule': {'locations': [{'city': 'Hung Hom', 'status': 'RECRUITING', 'country': 'Hong Kong', 'contacts': [{'name': 'Dennis Yan Yin Tse, PhD', 'role': 'CONTACT', 'email': 'dennis.tse@polyu.edu.hk', 'phone': '852-27666096'}, {'name': 'Rachel Ka Man Chun, PhD', 'role': 'CONTACT', 'email': 'rachel.chun@polyu.edu.hk', 'phone': '852-27664224'}], 'facility': 'School of Optometry, The Hong Kong Polytechnic University', 'geoPoint': {'lat': 22.30715, 'lon': 114.18532}}], 'centralContacts': [{'name': 'Dennis Yan Yin Tse, PhD', 'role': 'CONTACT', 'email': 'dennis.tse@polyu.edu.hk', 'phone': '852-27666096'}, {'name': 'Rachel Ka Man Chun, PhD', 'role': 'CONTACT', 'email': 'rachel.chun@polyu.edu.hk', 'phone': '852-27664224'}], 'overallOfficials': [{'name': 'Dennis Yan Yin Tse, PhD', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': 'School of Optometry, The Hong Kong Polytechnic University'}]}, 'ipdSharingStatementModule': {'ipdSharing': 'NO'}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'The Hong Kong Polytechnic University', 'class': 'OTHER'}, 'collaborators': [{'name': 'HOYA Lens Thailand LTD.', 'class': 'INDUSTRY'}], 'responsibleParty': {'type': 'SPONSOR'}}}}