Ignite Creation Date:
2025-12-25 @ 12:19 AM
Ignite Modification Date:
2026-01-05 @ 3:06 PM
Study NCT ID:
NCT03761758
Status:
COMPLETED
Last Update Posted:
2018-12-03
First Post:
2018-11-29
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Tolerability of a Novel Spectacle Design With Reduced Peripheral Contrast
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': 'DEVICE_FEASIBILITY', 'interventionModel': 'PARALLEL'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 21}}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '2018-05-01', 'type': 'ACTUAL'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2018-11', 'completionDateStruct': {'date': '2018-07-19', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2018-11-30', 'studyFirstSubmitDate': '2018-11-29', 'studyFirstSubmitQcDate': '2018-11-30', 'lastUpdatePostDateStruct': {'date': '2018-12-03', 'type': 'ACTUAL'}, 'studyFirstPostDateStruct': {'date': '2018-12-03', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2018-07-19', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Distance Visual Acuity', 'timeFrame': '2 weeks', 'description': 'Measurement of best corrected distance visual acuity'}, {'measure': 'Contrast Sensitivity', 'timeFrame': '2 weeks', 'description': 'Measurement of contrast sensitivity'}, {'measure': 'Subjective Responses', 'timeFrame': '2 weeks', 'description': 'Assessment of subject responses related to wear time of spectacles'}]}, 'oversightModule': {'isUsExport': True, 'oversightHasDmc': False, 'isFdaRegulatedDrug': False, 'isUnapprovedDevice': True, 'isFdaRegulatedDevice': True}, 'conditionsModule': {'conditions': ['Myopia']}, 'descriptionModule': {'briefSummary': 'Prospective, randomized, subject-masked 3-arm clinical study to assess the pediatric acceptability across three iterations of a novel spectacle lens design.', 'detailedDescription': 'This feasibility study was conducted to assess the performance of three experimental spectacle lens designs (spectacle lenses) in children between 6 and 9 years of age with myopia.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['CHILD'], 'maximumAge': '12 Years', 'minimumAge': '6 Years', 'healthyVolunteers': True, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* Ages between 6 and 12 years\n* Myopia between -1.00 and -4.00 D\n\nExclusion Criteria:\n\n* Participating in any clinical or other research study\n* Contact lens wearer'}, 'identificationModule': {'nctId': 'NCT03761758', 'acronym': 'WALNUT', 'briefTitle': 'Tolerability of a Novel Spectacle Design With Reduced Peripheral Contrast', 'organization': {'class': 'INDUSTRY', 'fullName': 'SightGlass Vision, Inc.'}, 'officialTitle': 'Tolerability of a Novel Spectacle Design With Reduced Peripheral Contrast', 'orgStudyIdInfo': {'id': 'P/639/18/SG'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'EXPERIMENTAL', 'label': 'Lens Design 1', 'description': 'Spectacle lenses design 1, fitted into spectacle frames', 'interventionNames': ['Device: Spectacle lenses']}, {'type': 'EXPERIMENTAL', 'label': 'Lens Design 2', 'description': 'Spectacle lenses design 2, fitted into spectacle frames', 'interventionNames': ['Device: Spectacle lenses']}, {'type': 'EXPERIMENTAL', 'label': 'Lens Design 3', 'description': 'Spectacle lenses design 3, fitted into spectacle frames', 'interventionNames': ['Device: Spectacle lenses']}], 'interventions': [{'name': 'Spectacle lenses', 'type': 'DEVICE', 'description': 'Spectacle lenses with clear central apertures', 'armGroupLabels': ['Lens Design 1', 'Lens Design 2', 'Lens Design 3']}]}, 'contactsLocationsModule': {'locations': [{'zip': 'N2L 3G1', 'city': 'Waterloo', 'state': 'Ontario', 'country': 'Canada', 'facility': 'Centre for Ocular Research & Education', 'geoPoint': {'lat': 43.4668, 'lon': -80.51639}}], 'overallOfficials': [{'name': 'Joe Rappon, OD, MS', 'role': 'STUDY_DIRECTOR', 'affiliation': 'SightGlass Vision'}]}, 'ipdSharingStatementModule': {'ipdSharing': 'NO'}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'SightGlass Vision, Inc.', 'class': 'INDUSTRY'}, 'responsibleParty': {'type': 'SPONSOR'}}}}