Ignite Creation Date:
2025-12-25 @ 4:29 AM
Ignite Modification Date:
2025-12-26 @ 3:32 AM
Study NCT ID:
NCT04388020
Status:
COMPLETED
Last Update Posted:
2021-05-21
First Post:
2020-05-07
Is NOT Gene Therapy:
False
Has Adverse Events:
False
Brief Title:
Effects of Projected Peripheral Defocus on Ocular Biometrics
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': 'NA', 'maskingInfo': {'masking': 'NONE'}, 'primaryPurpose': 'TREATMENT', 'interventionModel': 'SINGLE_GROUP'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 12}}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '2020-04-11', 'type': 'ACTUAL'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2021-05', 'dispFirstSubmitDate': '2021-05-10', 'completionDateStruct': {'date': '2020-05-14', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2021-05-15', 'studyFirstSubmitDate': '2020-05-07', 'dispFirstSubmitQcDate': '2021-05-15', 'studyFirstSubmitQcDate': '2020-05-11', 'dispFirstPostDateStruct': {'date': '2021-05-21', 'type': 'ACTUAL'}, 'lastUpdatePostDateStruct': {'date': '2021-05-21', 'type': 'ACTUAL'}, 'studyFirstPostDateStruct': {'date': '2020-05-14', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2020-05-14', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Axial length (AL)', 'timeFrame': '1 hour', 'description': 'Change in AL from baseline in the test eye vs. control eye'}, {'measure': 'Choroidal thickness (CT)', 'timeFrame': '1 hour', 'description': 'Change in CT from baseline in the test eye vs. control eye'}]}, 'oversightModule': {'isUsExport': False, 'isFdaRegulatedDrug': False, 'isUnapprovedDevice': True, 'isFdaRegulatedDevice': True}, 'conditionsModule': {'conditions': ['Myopia']}, 'descriptionModule': {'briefSummary': 'Acucela Inc. intends to develop a medical device to significantly halt or reverse myopic progression, which is a significant public health concern across the world, especially in Asian demographics. Acucela is working towards a spectacle-like device (eSPECs), which will have a clear zone for unimpeded central visual tasks and a periphery that provides defocus in order to alter retinal physiology leading to myopia regulation. This study will establish the changes seen during a proof-of-concept that projected defocus in the periphery will stimulate physiological changes similar to those in the literature.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT'], 'maximumAge': '35 Years', 'minimumAge': '18 Years', 'healthyVolunteers': True, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* Spherical equivalent +2.00 to -4.00 diopters\n* Refractive cylinder ≤ 0.75 diopters\n* Visual acuity 20/20 -3 or better\n\nExclusion Criteria:\n\n* Pregnant or lactating\n* Active ocular infection\n* History of dry eye, strabismus, or amblyopia\n* Previous or planned ocular surgery\n* Use of medication known to affect vision or accommodation'}, 'identificationModule': {'nctId': 'NCT04388020', 'briefTitle': 'Effects of Projected Peripheral Defocus on Ocular Biometrics', 'organization': {'class': 'INDUSTRY', 'fullName': 'Kubota Vision Inc.'}, 'officialTitle': 'Effects of Projected Peripheral Defocus on Ocular Biometrics', 'orgStudyIdInfo': {'id': 'eSpec Phase IIB'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'EXPERIMENTAL', 'label': 'Test Arm', 'interventionNames': ['Device: Tabletop prototype of eSpecs: Active projection of defocused image in the peripheral visual field', 'Device: Tabletop prototype of eSpecs: No Active projection of defocused image in the peripheral visual field']}], 'interventions': [{'name': 'Tabletop prototype of eSpecs: Active projection of defocused image in the peripheral visual field', 'type': 'DEVICE', 'description': 'For the right/test eye, a defocused image is projected onto the peripheral retina while the subject views a distant, in-focus image', 'armGroupLabels': ['Test Arm']}, {'name': 'Tabletop prototype of eSpecs: No Active projection of defocused image in the peripheral visual field', 'type': 'DEVICE', 'description': 'For the left/control eye, no image is projected onto the peripheral retina. The subject views a distant, in-focus image.', 'armGroupLabels': ['Test Arm']}]}, 'contactsLocationsModule': {'locations': [{'zip': '10022', 'city': 'New York', 'state': 'New York', 'country': 'United States', 'facility': 'Manhattan Vision Associates/institute of Vision Research', 'geoPoint': {'lat': 40.71427, 'lon': -74.00597}}], 'overallOfficials': [{'name': 'Arkady Selenow, OD', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': 'Manhattan Vision Associates'}]}, 'ipdSharingStatementModule': {'ipdSharing': 'NO'}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Kubota Vision Inc.', 'class': 'INDUSTRY'}, 'responsibleParty': {'type': 'SPONSOR'}}}}