Ignite Creation Date:
2025-12-26 @ 11:12 PM
Ignite Modification Date:
2026-02-28 @ 10:38 PM
Study NCT ID:
NCT05943912
Status:
ACTIVE_NOT_RECRUITING
Last Update Posted:
2024-04-02
First Post:
2023-07-04
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Myopia Control Effect of DIMS Spectacle Lenses in Czech Children and Young Adults
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': 'COHORT'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 80}, 'patientRegistry': False}, 'statusModule': {'overallStatus': 'ACTIVE_NOT_RECRUITING', 'startDateStruct': {'date': '2023-04-17', 'type': 'ACTUAL'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2024-03', 'completionDateStruct': {'date': '2026-12-12', 'type': 'ESTIMATED'}, 'lastUpdateSubmitDate': '2024-03-29', 'studyFirstSubmitDate': '2023-07-04', 'studyFirstSubmitQcDate': '2023-07-04', 'lastUpdatePostDateStruct': {'date': '2024-04-02', 'type': 'ACTUAL'}, 'studyFirstPostDateStruct': {'date': '2023-07-13', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2026-10-10', 'type': 'ESTIMATED'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Axial length of eye', 'timeFrame': 'in 36 moths therapy', 'description': 'biometry (Lenstar 900)'}], 'secondaryOutcomes': [{'measure': 'Objective refraction', 'timeFrame': 'in 36 month therapy', 'description': 'autorefractometer (Huwitz)'}]}, 'oversightModule': {'oversightHasDmc': False, 'isFdaRegulatedDrug': False, 'isFdaRegulatedDevice': False}, 'conditionsModule': {'keywords': ['myopia', 'axial length', 'DIMS'], 'conditions': ['Myopia']}, 'descriptionModule': {'briefSummary': 'The aim of this clinical study is to compare the efficacy of DIMS technology spectacle lenses with conventional single vision spectacle lenses at slowing the progression of myopia in the category of children and young adults during three years.', 'detailedDescription': 'The study is non randomized, unmasked, observational and prospective. Participants aged 6-26 with progressing myopia (but no ocular pathology), all Caucasian, are divided in two groups according to single vision spectacle lenses (SV) and DIMS technology lenses (DIMS). The participants are followed during three years (axial length, refraction changes).\n\nDefocus incorporated multiple segments (DIMS) spectacle lenses were designed to slow myopia progression in children, based on the principle of peripheral myopic defocus. DIMS spectacles reduce the progression of myopia and reduce axial elongation by 50-60% compared to single vision (SV) lenses according to previous scientific studies conducted mostly on the Asian population under the age of 15.\n\nThe majority of myopia appears and progresses during childhood. The myopia stabilizes by the age of 18 years, a number of individuals may still present myopic changes.\n\nThe goals of our study:\n\n* compare the efficacy of DIMS spectacle lenses with SV spectacle lenses at slowing the progression of myopia in the category of Czech children and young adults (effect on axial length and refractive changes)\n* monitoring axial length and refractive changes in myopic children and young adults (aged 6-26)\n* monitoring adaptation to DIMS lenses in myopes aged 6-26 years monitoring the influence of the environment and individual behavior on the progression of myopia'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['CHILD', 'ADULT'], 'maximumAge': '26 Years', 'minimumAge': '6 Years', 'samplingMethod': 'PROBABILITY_SAMPLE', 'studyPopulation': 'To evaluate the efficacy of Defocus Incorporated Multiple Segment (DIMS) lenses in slowing myopia progression in a young European population of progressing myopes. A prospective, non-randomized, observational 3 - year study will be conducted in 80 progressing myopes aged 6-26 years, with myopia between -0,25D and -8,5D and astigmatism -0,25 and -2,25DC. Participants self-selected wearing DIMS (n=55) or single vision (SV) lenses (n=25). Spherical Equivalent Refraction (SER, cycloplegic autorefraction) and axial length (AL) were measured at baseline. AL will be measured at 3M, 6M and every 6M and SER will be measured every 12M.', 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* Progressive myopia\n* Myopes aged 6-26 years\n* Myopia between -0,25D and -8,5D\n* Astigmatism -0,25 and -2,25DC\n\nExclusion Criteria:\n\n* Ocular pathology\n* Amblyopia\n* Strabism\n* Non-compliance to eye examinations'}, 'identificationModule': {'nctId': 'NCT05943912', 'briefTitle': 'Myopia Control Effect of DIMS Spectacle Lenses in Czech Children and Young Adults', 'organization': {'class': 'OTHER', 'fullName': 'Czech Technical University in Prague'}, 'officialTitle': 'Myopia Control Effect of DIMS Spectacle Lenses in Czech Children and Young Adults', 'orgStudyIdInfo': {'id': 'SGS23/195/OHK4/3T/17'}}, 'armsInterventionsModule': {'armGroups': [{'label': 'Single Vision Spectacle Lens', 'description': 'Participants who chose to correct myopia with single vision spectacle lenses.', 'interventionNames': ['Other: Single Vision Spectacle Lens']}, {'label': 'Defocus Incorporated Multiple Segments (DIMS) Spectacle Lens', 'description': 'Participants who chose to correct myopia with DIMS spectacle lenses.', 'interventionNames': ['Other: Defocus Incorporated Multiple Segments (DIMS) Spectacle Lens']}], 'interventions': [{'name': 'Single Vision Spectacle Lens', 'type': 'OTHER', 'description': '36 months of therapy', 'armGroupLabels': ['Single Vision Spectacle Lens']}, {'name': 'Defocus Incorporated Multiple Segments (DIMS) Spectacle Lens', 'type': 'OTHER', 'description': '36 months of therapy', 'armGroupLabels': ['Defocus Incorporated Multiple Segments (DIMS) Spectacle Lens']}]}, 'contactsLocationsModule': {'locations': [{'city': 'Prague', 'state': 'Czech Republic', 'country': 'Czechia', 'facility': 'Czech Technical University', 'geoPoint': {'lat': 50.08804, 'lon': 14.42076}}], 'overallOfficials': [{'name': 'Marketa Zakova, Ph.D.', 'role': 'STUDY_DIRECTOR', 'affiliation': 'Czech Technical University in Prague'}]}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Czech Technical University in Prague', 'class': 'OTHER'}, 'responsibleParty': {'type': 'SPONSOR'}}}}