Ignite Creation Date:
2025-12-26 @ 2:39 PM
Ignite Modification Date:
2025-12-29 @ 11:15 AM
Study NCT ID:
NCT05250206
Status:
COMPLETED
Last Update Posted:
2025-06-10
First Post:
2022-02-03
Is Gene Therapy:
True
Has Adverse Events:
True
Brief Title:
Evaluation of the Efficacy in Decreasing Myopia Progression of the Proposed Ophthalmic Lens Prototypes
Sponsor:
Organization:
Raw JSON
{'hasResults': True, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'conditionBrowseModule': {'meshes': [{'id': 'D009216', 'term': 'Myopia'}], 'ancestors': [{'id': 'D012030', 'term': 'Refractive Errors'}, {'id': 'D005128', 'term': 'Eye Diseases'}]}}, 'resultsSection': {'moreInfoModule': {'pointOfContact': {'email': 'evachamorro@iot.es', 'phone': '+34 (91) 833 37 86', 'title': 'Director of Clinical Trials', 'organization': 'Indizen Optical Technologies (Madrid), Universidad Complutense de Madrid'}, 'certainAgreement': {'piSponsorEmployee': True, 'restrictiveAgreement': False}}, 'adverseEventsModule': {'timeFrame': 'From baseline through 24 months of follow-up', 'description': 'Adverse events were monitored continuously from baseline to study completion (24 months). Only participants who completed the study were included in the final safety analysis (n=69).', 'eventGroups': [{'id': 'EG000', 'title': 'Control Group', 'description': 'The control group consisted of 34 children using standard spherocylindrical lenses.', 'otherNumAtRisk': 34, 'deathsNumAtRisk': 34, 'otherNumAffected': 0, 'seriousNumAtRisk': 34, 'deathsNumAffected': 0, 'seriousNumAffected': 0}, {'id': 'EG001', 'title': 'Treatment Group', 'description': "The treatment group included 35 children wearing a prototype lens with a central zone that provides the patient's optimal prescription surrounded by a zone of positive defocus that increases progressively from the center to the periphery of the lens, in an asymmetrical manner between the different zones of the lens.", 'otherNumAtRisk': 35, 'deathsNumAtRisk': 35, 'otherNumAffected': 0, 'seriousNumAtRisk': 35, 'deathsNumAffected': 0, 'seriousNumAffected': 0}], 'frequencyThreshold': '0'}, 'outcomeMeasuresModule': {'outcomeMeasures': [{'type': 'PRIMARY', 'title': 'Axial Lenght Increase', 'denoms': [{'units': 'Participants', 'counts': [{'value': '34', 'groupId': 'OG000'}, {'value': '35', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'Myopia Control Lens', 'description': 'The control group consisted of 42 children using standard spherocylindrical lenses.'}, {'id': 'OG001', 'title': 'Treatment Group', 'description': "The treatment group included 41 children wearing a prototype lens with a central zone that provides the patient's optimal prescription surrounded by a zone of positive defocus that increases progressively from the center to the periphery of the lens, in an asymmetrical manner between the different zones of the lens."}], 'classes': [{'categories': [{'measurements': [{'value': '0.27', 'spread': '0.23', 'groupId': 'OG000'}, {'value': '0.37', 'spread': '0.24', 'groupId': 'OG001'}]}]}], 'paramType': 'MEAN', 'timeFrame': '5 minutes', 'description': 'Axial length was measured with the IOL Master® optical biometer (Carl Zeiss Meditec, Jena, Germany) and axial length growth was calculated by subtracting the axial length measurement after one year of treatment and the axial length at the initial visit.', 'unitOfMeasure': 'mm', 'dispersionType': 'Standard Deviation', 'reportingStatus': 'POSTED'}]}, 'participantFlowModule': {'groups': [{'id': 'FG000', 'title': 'Control Lens', 'description': 'Standard spherocylindrical lenses.'}, {'id': 'FG001', 'title': 'Treatment Lens', 'description': "Lenses with a central zone that provides the patient's optimal prescription surrounded by a zone of positive defocus that increases progressively from the center to the periphery of the lens, in an asymmetrical manner between the different zones of the lens."}], 'periods': [{'title': 'Overall Study', 'milestones': [{'type': 'STARTED', 'achievements': [{'groupId': 'FG000', 'numSubjects': '46'}, {'groupId': 'FG001', 'numSubjects': '46'}]}, {'type': 'COMPLETED', 'achievements': [{'groupId': 'FG000', 'numSubjects': '34'}, {'groupId': 'FG001', 'numSubjects': '35'}]}, {'type': 'NOT COMPLETED', 'achievements': [{'groupId': 'FG000', 'numSubjects': '12'}, {'groupId': 'FG001', 'numSubjects': '11'}]}]}]}, 'baselineCharacteristicsModule': {'denoms': [{'units': 'Participants', 'counts': [{'value': '34', 'groupId': 'BG000'}, {'value': '35', 'groupId': 'BG001'}, {'value': '69', 'groupId': 'BG002'}]}], 'groups': [{'id': 'BG000', 'title': 'Control Group', 'description': 'The control group consisted of 34 children using standard spherocylindrical lenses.'}, {'id': 'BG001', 'title': 'Treatment Group', 'description': "The treatment group included 35 children wearing a prototype lens with a central zone that provides the patient's optimal prescription surrounded by a zone of positive defocus that increases progressively from the center to the periphery of the lens, in an asymmetrical manner between the different zones of the lens."}, {'id': 'BG002', 'title': 'Total', 'description': 'Total of all reporting groups'}], 'measures': [{'title': 'Age, Continuous', 'classes': [{'categories': [{'measurements': [{'value': '9.6', 'spread': '1.8', 'groupId': 'BG000'}, {'value': '10.4', 'spread': '1.8', 'groupId': 'BG001'}, {'value': '10.0', 'spread': '1.8', 'groupId': 'BG002'}]}]}], 'paramType': 'MEAN', 'description': 'The age of the children who participated in the study ranged from 6.4 to 13.7 years', 'unitOfMeasure': 'years', 'dispersionType': 'STANDARD_DEVIATION'}, {'title': 'Sex: Female, Male', 'classes': [{'categories': [{'title': 'Female', 'measurements': [{'value': '17', 'groupId': 'BG000'}, {'value': '23', 'groupId': 'BG001'}, {'value': '40', 'groupId': 'BG002'}]}, {'title': 'Male', 'measurements': [{'value': '17', 'groupId': 'BG000'}, {'value': '12', 'groupId': 'BG001'}, {'value': '29', 'groupId': 'BG002'}]}]}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'unitOfMeasure': 'Participants'}, {'title': 'Race/Ethnicity, Customized', 'classes': [{'title': 'Spanish children', 'categories': [{'measurements': [{'value': '34', 'groupId': 'BG000'}, {'value': '35', 'groupId': 'BG001'}, {'value': '69', 'groupId': 'BG002'}]}]}], 'paramType': 'NUMBER', 'unitOfMeasure': 'participants'}], 'populationDescription': '92 children were enrolled and 23 of the participants did not complete the study. Thus, the final sample was 69 children.'}}, 'documentSection': {'largeDocumentModule': {'largeDocs': [{'date': '2021-04-26', 'size': 534085, 'label': 'Study Protocol and Statistical Analysis Plan', 'hasIcf': False, 'hasSap': True, 'filename': 'Prot_SAP_000.pdf', 'typeAbbrev': 'Prot_SAP', 'uploadDate': '2024-10-17T08:27', 'hasProtocol': True}]}}, 'protocolSection': {'designModule': {'phases': ['NA'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'NA', 'maskingInfo': {'masking': 'NONE'}, 'primaryPurpose': 'PREVENTION', 'interventionModel': 'SINGLE_GROUP'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 92}}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '2021-06-07', 'type': 'ACTUAL'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2025-02', 'completionDateStruct': {'date': '2024-11-30', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2025-05-22', 'studyFirstSubmitDate': '2022-02-03', 'resultsFirstSubmitDate': '2023-12-01', 'studyFirstSubmitQcDate': '2022-02-17', 'lastUpdatePostDateStruct': {'date': '2025-06-10', 'type': 'ACTUAL'}, 'resultsFirstSubmitQcDate': '2025-05-22', 'studyFirstPostDateStruct': {'date': '2022-02-22', 'type': 'ACTUAL'}, 'resultsFirstPostDateStruct': {'date': '2025-06-10', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2024-11-30', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Axial Lenght Increase', 'timeFrame': '5 minutes', 'description': 'Axial length was measured with the IOL Master® optical biometer (Carl Zeiss Meditec, Jena, Germany) and axial length growth was calculated by subtracting the axial length measurement after one year of treatment and the axial length at the initial visit.'}]}, 'oversightModule': {'oversightHasDmc': True, 'isFdaRegulatedDrug': False, 'isFdaRegulatedDevice': False}, 'conditionsModule': {'conditions': ['Myopia']}, 'referencesModule': {'references': [{'pmid': '25270192', 'type': 'BACKGROUND', 'citation': 'Hasebe S, Jun J, Varnas SR. Myopia control with positively aspherized progressive addition lenses: a 2-year, multicenter, randomized, controlled trial. Invest Ophthalmol Vis Sci. 2014 Sep 30;55(11):7177-88. doi: 10.1167/iovs.12-11462.'}, {'pmid': '30083910', 'type': 'BACKGROUND', 'citation': 'Kanda H, Oshika T, Hiraoka T, Hasebe S, Ohno-Matsui K, Ishiko S, Hieda O, Torii H, Varnas SR, Fujikado T. Effect of spectacle lenses designed to reduce relative peripheral hyperopia on myopia progression in Japanese children: a 2-year multicenter randomized controlled trial. Jpn J Ophthalmol. 2018 Sep;62(5):537-543. doi: 10.1007/s10384-018-0616-3. Epub 2018 Aug 6.'}, {'pmid': '22559900', 'type': 'BACKGROUND', 'citation': 'Morgan IG, Ohno-Matsui K, Saw SM. Myopia. Lancet. 2012 May 5;379(9827):1739-48. doi: 10.1016/S0140-6736(12)60272-4.'}]}, 'descriptionModule': {'briefSummary': 'Evaluation of the efficacy in decreasing myopia progression of the proposed ophthalmic lens prototypes.', 'detailedDescription': 'A prospective, double-blind, randomized clinical trial (RCT) to analyze the effect of a new ophthalmic lens prototype on myopia progression. The follow-up period to evaluate the efficacy of the lens will be 3 years including a total of 5 visits.\n\nThe sample will consist of a group of 92 myopic children who will be randomly assigned to one of the treatment groups:\n\n* Control group who will receive standard monofocal lenses.\n* Treatment group who will wear a prototype lens based on peripheral positive defocus.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['CHILD'], 'maximumAge': '12 Years', 'minimumAge': '5 Years', 'healthyVolunteers': True, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* Age: 5 to 12 years old\n* Myopia (spherical equivalent with cycloplegic) ≤ -0.50D\n* Astigmatism \\< 1.50D\n* Anisometropia \\< 1.50D\n* Best-corrected visual acuity ≥ 20/20\n\nExclusion Criteria:\n\n* Patients who have received any previous treatment for myopia control, including the use of RPG contact lenses.\n* Participants with ocular pathology such as retinal detachment.\n* Participants using drugs that may affect pupillary size and accommodation or that produce effects on the ocular surface.\n* Participants with systemic diseases that may affect vision.'}, 'identificationModule': {'nctId': 'NCT05250206', 'briefTitle': 'Evaluation of the Efficacy in Decreasing Myopia Progression of the Proposed Ophthalmic Lens Prototypes', 'organization': {'class': 'INDUSTRY', 'fullName': 'Indizen Optical Technologies, S.L.U.'}, 'officialTitle': 'Evaluation of Ophthalmic Lenses for Myopia Management', 'orgStudyIdInfo': {'id': 'IOT-MIO-2018-01'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'EXPERIMENTAL', 'label': 'Axial lenght increase', 'description': 'Children aged 5 to 12 with myopia up to -0.50 D, astigmatism and anisometropia under 1.50 D, and corrected visual acuity over 20/20 will be randomized to either the control group or treatment group. The myopia progression was evaluated by measuring axial length (AL) growth (IOL Master; Zeiss) over a period of one year.', 'interventionNames': ['Other: Myopia control lens']}], 'interventions': [{'name': 'Myopia control lens', 'type': 'OTHER', 'description': 'Evaluation of the efficacy in decreasing myopia progression of the proposed ophthalmic lens prototypes.', 'armGroupLabels': ['Axial lenght increase']}]}, 'contactsLocationsModule': {'locations': [{'zip': '28670', 'city': 'Madrid', 'country': 'Spain', 'facility': 'Universidad Europea of Madrid', 'geoPoint': {'lat': 40.4165, 'lon': -3.70256}}]}, 'ipdSharingStatementModule': {'ipdSharing': 'NO'}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Indizen Optical Technologies, S.L.U.', 'class': 'INDUSTRY'}, 'collaborators': [{'name': 'Universidad Europea de Madrid', 'class': 'OTHER'}], 'responsibleParty': {'type': 'SPONSOR'}}}}