Ignite Creation Date:
2025-12-25 @ 1:39 AM
Ignite Modification Date:
2025-12-26 @ 4:04 AM
Study NCT ID:
NCT05617794
Status:
ACTIVE_NOT_RECRUITING
Last Update Posted:
2024-12-20
First Post:
2022-11-01
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Effect of Diffusion Optics Technology (DOT) Spectacle Lenses on Choroidal Thickness
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': 'RANDOMIZED', 'maskingInfo': {'masking': 'SINGLE', 'whoMasked': ['PARTICIPANT']}, 'primaryPurpose': 'TREATMENT', 'interventionModel': 'CROSSOVER'}, 'enrollmentInfo': {'type': 'ESTIMATED', 'count': 30}}, 'statusModule': {'overallStatus': 'ACTIVE_NOT_RECRUITING', 'startDateStruct': {'date': '2023-01-18', 'type': 'ACTUAL'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2024-12', 'completionDateStruct': {'date': '2026-03-31', 'type': 'ESTIMATED'}, 'lastUpdateSubmitDate': '2024-12-18', 'studyFirstSubmitDate': '2022-11-01', 'studyFirstSubmitQcDate': '2022-11-11', 'lastUpdatePostDateStruct': {'date': '2024-12-20', 'type': 'ACTUAL'}, 'studyFirstPostDateStruct': {'date': '2022-11-15', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2023-04-30', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Choroidal Thickness', 'timeFrame': '30 minutes and 60 minutes', 'description': 'Change from Baseline, 30 minutes and 60 minutes'}, {'measure': 'Retinal and Choroidal Thickness', 'timeFrame': '30 minutes and 60 minutes', 'description': 'Change from Baseline, 30 minutes and 60 minutes'}], 'secondaryOutcomes': [{'measure': 'Software Method Comparison', 'timeFrame': '30 minutes and 60 minutes', 'description': 'Comparison of measurements using different software methods; manual, semiautomated and automated software'}]}, 'oversightModule': {'isUsExport': True, 'oversightHasDmc': False, 'isFdaRegulatedDrug': False, 'isUnapprovedDevice': True, 'isFdaRegulatedDevice': True}, 'conditionsModule': {'conditions': ['Myopia', 'Myopia Progression', 'Juvenile Myopia']}, 'descriptionModule': {'briefSummary': 'The objective of the study is to measure the effect of Diffusion Optics Technology (DOT) spectacle lenses on the choroidal thickness and choroidal vascularity index compared to control lenses.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['CHILD'], 'maximumAge': '14 Years', 'minimumAge': '8 Years', 'healthyVolunteers': True, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* Are 8-14 years of age;\n* Are able to read (or be read to), understand and sign the assent document;\n* Are accompanied by a parent or legal guardian who is able to read, understand and sign the parental information and permission document;\n* Are emmetropic by non-cycloplegic auto-refraction, which means both refractive meridians should be within +1.00D and -1.00D inclusively;\n* Are willing and able to follow instructions.\n\nExclusion Criteria:\n\n* Are participating in any concurrent interventional clinical or research study;\n* Have a history of myopia control treatment in the past year;\n* Have amblyopia in either eye or known to have any other binocular vision disorder, such as accommodative insufficiency;\n* Have any known active ocular disease and/or infection;\n* Have a systemic condition that in the opinion of the investigator may affect a study outcome variable. Examples include diabetes mellitus, hyperthyroidism;\n* Are using any systemic or topical medications that in the opinion of the investigator may affect a study outcome variable. Examples include Atropine eye drops;\n* Have undergone strabismus surgery, refractive error surgery or intraocular surgery;\n* Are a child of a member of the study team.'}, 'identificationModule': {'nctId': 'NCT05617794', 'acronym': 'ASH-2', 'briefTitle': 'Effect of Diffusion Optics Technology (DOT) Spectacle Lenses on Choroidal Thickness', 'organization': {'class': 'INDUSTRY', 'fullName': 'SightGlass Vision, Inc.'}, 'officialTitle': 'Effect of Diffusion Optics Technology (DOT) Spectacle Lenses on Choroidal Thickness and Choroidal Vascularity Index in Emmetropes', 'orgStudyIdInfo': {'id': 'CPRO-2207-001'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'EXPERIMENTAL', 'label': 'Treatment 1 - Diffusion Optics Technology (DOT) Pattern', 'interventionNames': ['Device: Diffusion Optics Technology (DOT) Pattern Spectacle Lens']}, {'type': 'ACTIVE_COMPARATOR', 'label': 'Treatment 2 - Control Spectacles', 'interventionNames': ['Device: Control Spectacle Lens']}], 'interventions': [{'name': 'Diffusion Optics Technology (DOT) Pattern Spectacle Lens', 'type': 'DEVICE', 'description': 'DOT Pattern Spectacle Lens', 'armGroupLabels': ['Treatment 1 - Diffusion Optics Technology (DOT) Pattern']}, {'name': 'Control Spectacle Lens', 'type': 'DEVICE', 'description': 'Control Spectacles', 'armGroupLabels': ['Treatment 2 - Control Spectacles']}]}, 'contactsLocationsModule': {'locations': [{'zip': 'N2L 3G1', 'city': 'Waterloo', 'state': 'Ontario', 'country': 'Canada', 'facility': 'Centre for Ocular Research and Education', 'geoPoint': {'lat': 43.4668, 'lon': -80.51639}}]}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'SightGlass Vision, Inc.', 'class': 'INDUSTRY'}, 'collaborators': [{'name': 'University of Waterloo', 'class': 'OTHER'}], 'responsibleParty': {'type': 'SPONSOR'}}}}