Ignite Creation Date:
2025-12-25 @ 2:38 AM
Ignite Modification Date:
2025-12-28 @ 12:07 AM
Study NCT ID:
NCT00919334
Status:
COMPLETED
Last Update Posted:
2014-07-03
First Post:
2009-06-11
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Myopia Control With Simultaneous Vision Approach
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': 'D007909', 'term': 'Lenses'}], 'ancestors': [{'id': 'D055096', 'term': 'Optical Devices'}, {'id': 'D004864', 'term': 'Equipment and Supplies'}]}}, 'protocolSection': {'designModule': {'phases': ['PHASE1'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'RANDOMIZED', 'maskingInfo': {'masking': 'DOUBLE', 'whoMasked': ['PARTICIPANT', 'INVESTIGATOR']}, 'primaryPurpose': 'TREATMENT', 'interventionModel': 'PARALLEL'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 100}}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '2007-07'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2014-07', 'completionDateStruct': {'date': '2011-06', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2014-07-02', 'studyFirstSubmitDate': '2009-06-11', 'studyFirstSubmitQcDate': '2009-06-11', 'lastUpdatePostDateStruct': {'date': '2014-07-03', 'type': 'ESTIMATED'}, 'studyFirstPostDateStruct': {'date': '2009-06-12', 'type': 'ESTIMATED'}, 'primaryCompletionDateStruct': {'date': '2011-01', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'The changes of cycloplegic refractive errors', 'timeFrame': 'every 6 months for 2 years', 'description': 'Refractive error was measured using Shin-Nippon NVision-K 5001 autorefractor The changes of cycloplegic objective refractive errors between the treatment and the control were compared.'}], 'secondaryOutcomes': [{'measure': 'The changes of axial length', 'timeFrame': 'every 6 months for 2 years', 'description': 'Axial length was measured after cycloplegia using IOL Master'}]}, 'oversightModule': {'oversightHasDmc': True}, 'conditionsModule': {'keywords': ['Myopia progression', 'Myopia control', 'Simultaneous vision', 'Myopic defocus'], 'conditions': ['Myopia']}, 'referencesModule': {'references': [{'pmid': '24169657', 'type': 'RESULT', 'citation': 'Lam CS, Tang WC, Tse DY, Tang YY, To CH. Defocus Incorporated Soft Contact (DISC) lens slows myopia progression in Hong Kong Chinese schoolchildren: a 2-year randomised clinical trial. Br J Ophthalmol. 2014 Jan;98(1):40-5. doi: 10.1136/bjophthalmol-2013-303914. Epub 2013 Oct 29.'}, {'pmid': '36809645', 'type': 'DERIVED', 'citation': 'Lawrenson JG, Shah R, Huntjens B, Downie LE, Virgili G, Dhakal R, Verkicharla PK, Li D, Mavi S, Kernohan A, Li T, Walline JJ. Interventions for myopia control in children: a living systematic review and network meta-analysis. Cochrane Database Syst Rev. 2023 Feb 16;2(2):CD014758. doi: 10.1002/14651858.CD014758.pub2.'}]}, 'descriptionModule': {'briefSummary': "To determine if the 'Defocus Incorporated Soft Contact' (DISC) lens slows myopia progression in Hong Kong schoolchildren using simultaneous vision approach.", 'detailedDescription': 'The investigators hypothesize that the natural process of emmetropization in human is regulated by the equilibrium between the opposite hyperopic and myopic defocus. A sharp focus of retinal image (foveal fixation) is fundamental for co-ordination of the equilibrium. The DISC lens is a custom-made multi-zone bifocal soft contact lens which is based on simultaneously provides clear vision and defocus at all viewing distances. It comprises of correcting zones for correcting distant prescription(correction of refractive error, and defocusing zones to incorporate constant myopic defocus for slowing down myopia progression.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['CHILD'], 'maximumAge': '13 Years', 'minimumAge': '8 Years', 'healthyVolunteers': True, 'eligibilityCriteria': "Inclusion Criteria:\n\n* Age 8-13 years\n* Myopia (SE) between -1D to -5D\n* Astigmatism less than or equal to -1D\n* Anisometropia: less than or equal to 1.25D\n* aided VA (monocular): 0.00 log MAR or better\n* willingness to wear contact lens constantly\n* availability for follow-up for at least 2.5 years\n* parents' understanding and acceptance\n* willing to provide refractive status of grandparents\n\nExclusion Criteria:\n\n* Severe ocular or systemic allergies\n* Taking any medication that might have an impact on contact lens wear or that might influence the outcome of the clinical trial\n* Ocular or systemic condition that might affect refractive development\n* Strabismus at distance or near\n* Prior use of bifocal or progressive lenses\n* Prior use of rigid gas permeable lenses and Ortho-K lenses"}, 'identificationModule': {'nctId': 'NCT00919334', 'briefTitle': 'Myopia Control With Simultaneous Vision Approach', 'organization': {'class': 'OTHER', 'fullName': 'The Hong Kong Polytechnic University'}, 'officialTitle': 'Control of Myopia Progression in Myopic Children Using Simultaneous Vision Approach', 'orgStudyIdInfo': {'id': 'GRF5438/06M'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'NO_INTERVENTION', 'label': 'single vision soft contact lens', 'description': 'Single vision soft contact lenses with same materials of the DISC lens'}, {'type': 'EXPERIMENTAL', 'label': 'Defocus Incorporated Soft Contact (DISC) lens', 'description': 'The use of DISC lens to slow down the progression of myopia', 'interventionNames': ['Device: Defocus Incorporated Soft Contact (DISC) lens']}], 'interventions': [{'name': 'Defocus Incorporated Soft Contact (DISC) lens', 'type': 'DEVICE', 'otherNames': ['myopia control', 'myopia progression', 'Simultaneous vision', 'bifocal contact lens'], 'description': 'Use of simultaneous vision bifocal soft contact lenses with myopic defocus to control the progression of myopia', 'armGroupLabels': ['Defocus Incorporated Soft Contact (DISC) lens']}]}, 'contactsLocationsModule': {'locations': [{'city': 'Hong Kong', 'country': 'China', 'facility': 'Optometry Clinic, School of Optometry, The Hong Kong PolyU', 'geoPoint': {'lat': 22.27832, 'lon': 114.17469}}], 'overallOfficials': [{'name': 'Carly SY Lam, PhD', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': 'School of Optometry, The Hong Kong PolyU'}]}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'The Hong Kong Polytechnic University', 'class': 'OTHER'}, 'responsibleParty': {'type': 'PRINCIPAL_INVESTIGATOR', 'investigatorTitle': 'Head of School', 'investigatorFullName': 'Carly Lam', 'investigatorAffiliation': 'The Hong Kong Polytechnic University'}}}}