Ignite Creation Date:
2025-12-24 @ 9:44 PM
Ignite Modification Date:
2025-12-27 @ 10:18 PM
Study NCT ID:
NCT06450132
Status:
RECRUITING
Last Update Posted:
2024-10-31
First Post:
2024-06-04
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Changes in Eye Shape With Myopia Management Interventions
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': ['PHASE4'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'RANDOMIZED', 'maskingInfo': {'masking': 'SINGLE', 'whoMasked': ['OUTCOMES_ASSESSOR'], 'maskingDescription': 'The participants and the examining investigator will not be masked to intervention. All measurements are objective in nature and not subject to examiner bias. All data images acquired will be coded to obscure participant ID by a study team member masked to intervention. This coding will allow for the examining investigator to complete image processing while masked to randomization assignment, thereby minimizing the chance of bias.'}, 'primaryPurpose': 'BASIC_SCIENCE', 'interventionModel': 'PARALLEL'}, 'enrollmentInfo': {'type': 'ESTIMATED', 'count': 75}}, 'statusModule': {'overallStatus': 'RECRUITING', 'startDateStruct': {'date': '2024-08-01', 'type': 'ACTUAL'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2024-10', 'completionDateStruct': {'date': '2026-07-31', 'type': 'ESTIMATED'}, 'lastUpdateSubmitDate': '2024-10-29', 'studyFirstSubmitDate': '2024-06-04', 'studyFirstSubmitQcDate': '2024-06-04', 'lastUpdatePostDateStruct': {'date': '2024-10-31', 'type': 'ACTUAL'}, 'studyFirstPostDateStruct': {'date': '2024-06-10', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2026-06-30', 'type': 'ESTIMATED'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Change in ocular shape', 'timeFrame': 'baseline to 12 months', 'description': 'ocular shape, as measured by the ellipsoid fit of the retina acquired by the photos taken with ocular ultrasound (ABSolu, Quantel Medical)'}], 'secondaryOutcomes': [{'measure': 'Axial elongation (or regression)', 'timeFrame': 'baseline to 12 months', 'description': 'change in axial length of the eye, as measured by Lenstar 900 (Haag-Streit)'}, {'measure': 'Change in accommodative response', 'timeFrame': 'baseline to 12 months', 'description': 'change in focusing ability of the eye, as measured with near targets and the Grand Seiko WR-5100K'}, {'measure': 'Change in refractive error', 'timeFrame': 'baseline to 12 months', 'description': 'change in refractive error, as measured with the Grand Seiko WR-5100K'}]}, 'oversightModule': {'isUsExport': True, 'oversightHasDmc': False, 'isFdaRegulatedDrug': True, 'isFdaRegulatedDevice': True}, 'conditionsModule': {'conditions': ['Myopia']}, 'descriptionModule': {'briefSummary': 'The goal of this clinical trial is to study changes in eye shape of nearsighted young adults using low-dose atropine eye drops or soft multifocal contact lenses. The main questions it aims to answer are:\n\n* do low-dose atropine and soft multifocal contact lenses affect the shape of the peripheral eye?\n* are changes in peripheral eye shape from these interventions influenced by changes in the focusing system of the eye?\n\nParticipants will:\n\n* have multiple different types of photos taken\n* have their prescription for glasses/contacts checked\n* have their eye health checked, including the use of dilating eye drops\n* be randomly assigned to use eye drops every night or wear special contact lenses daily instead of their typical contacts\n* will complete five study visits over the course of 12 months\n\nResearchers will compare young adults using low-dose atropine to those wearing soft multifocal contact lenses and to those using no intervention to see if using these interventions affects retinal shape.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT'], 'maximumAge': '30 Years', 'minimumAge': '21 Years', 'healthyVolunteers': True, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* best corrected visual acuity of 20/25 or better in each eye\n* nearsighted\n* current contact lens wearer\n* normal binocular vision (to be determined by an examiner at the first study visit)\n\nExclusion Criteria:\n\n* eye diseases (including lazy eye or eye turn)\n* pregnant, nursing, or planning a pregnancy in the next 12 months\n* history of refractive surgery (e.g., LASIK)\n* history of myopia control treatment\n* sensitivity to anesthetics or preservative in eye drops\n* difficulty with pupillary dilation'}, 'identificationModule': {'nctId': 'NCT06450132', 'briefTitle': 'Changes in Eye Shape With Myopia Management Interventions', 'organization': {'class': 'OTHER', 'fullName': 'Ohio State University'}, 'officialTitle': 'Longitudinal Changes in Eye Shape in Young Adults Treated With Low-Dose Atropine and Soft Multifocal Contact Lenses', 'orgStudyIdInfo': {'id': '2023H0321'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'NO_INTERVENTION', 'label': 'Observation', 'description': 'Participants randomized to the observation arm will receive no intervention.'}, {'type': 'EXPERIMENTAL', 'label': 'Low-dose atropine', 'description': 'Participants randomized to low-dose atropine will instill one drop of 0.05% atropine in each eye at bedtime for 12 months.', 'interventionNames': ['Drug: Atropine Ophthalmic']}, {'type': 'EXPERIMENTAL', 'label': 'Soft multifocal contact lenses', 'description': 'Participants randomized to soft multifocal contact lenses will wear MiSight 1-day disposable contact lenses for 5-7 days per week for 12 months.', 'interventionNames': ['Device: MiSight 1-day disposable contact lenses']}], 'interventions': [{'name': 'Atropine Ophthalmic', 'type': 'DRUG', 'description': '0.05% atropine ophthalmic solution', 'armGroupLabels': ['Low-dose atropine']}, {'name': 'MiSight 1-day disposable contact lenses', 'type': 'DEVICE', 'description': 'soft multifocal contact lenses', 'armGroupLabels': ['Soft multifocal contact lenses']}]}, 'contactsLocationsModule': {'locations': [{'zip': '43210', 'city': 'Columbus', 'state': 'Ohio', 'status': 'RECRUITING', 'country': 'United States', 'contacts': [{'name': 'Donald O Mutti, OD, PhD', 'role': 'CONTACT', 'email': 'mutti.2@osu.edu', 'phone': '614-247-7057'}, {'name': 'Marielle G Reidy, OD, MS', 'role': 'CONTACT', 'email': 'reidy.39@osu.edu', 'phone': '614-688-0028'}, {'name': 'Donald O Mutti, OD, PhD', 'role': 'PRINCIPAL_INVESTIGATOR'}], 'facility': 'The Ohio State University', 'geoPoint': {'lat': 39.96118, 'lon': -82.99879}}], 'centralContacts': [{'name': 'Marielle G Reidy, OD, MS', 'role': 'CONTACT', 'email': 'reidy.39@osu.edu', 'phone': '614-688-0028'}, {'name': 'Donald O Mutti, OD, PhD', 'role': 'CONTACT', 'email': 'mutti.2@osu.edu', 'phone': '614-247-7057'}], 'overallOfficials': [{'name': 'Donald O Mutti, OD, PhD', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': 'Ohio State University'}]}, 'ipdSharingStatementModule': {'ipdSharing': 'NO'}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Ohio State University', 'class': 'OTHER'}, 'responsibleParty': {'type': 'PRINCIPAL_INVESTIGATOR', 'investigatorTitle': 'EF Wildermuth Foundation Professor in Optometry', 'investigatorFullName': 'Donald O Mutti, OD, PhD', 'investigatorAffiliation': 'Ohio State University'}}}}