Ignite Creation Date:
2025-12-25 @ 4:12 AM
Ignite Modification Date:
2025-12-26 @ 3:10 AM
Study NCT ID:
NCT06110520
Status:
RECRUITING
Last Update Posted:
2025-12-22
First Post:
2023-06-13
Is NOT Gene Therapy:
False
Has Adverse Events:
False
Brief Title:
Violet Light for the Suppression of Myopia
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'}]}}, 'documentSection': {'largeDocumentModule': {'largeDocs': [{'date': '2023-07-02', 'size': 375218, 'label': 'Study Protocol', 'hasIcf': False, 'hasSap': False, 'filename': 'Prot_000.pdf', 'typeAbbrev': 'Prot', 'uploadDate': '2023-10-09T15:44', 'hasProtocol': True}]}}, 'protocolSection': {'designModule': {'phases': ['NA'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'RANDOMIZED', 'maskingInfo': {'masking': 'TRIPLE', 'whoMasked': ['PARTICIPANT', 'CARE_PROVIDER', 'INVESTIGATOR'], 'maskingDescription': 'Patients will be randomized into one of three study groups. The patient, their caregiver, and the investigator will be masked to their treatment group. The study coordinator will organize the patients study treatment and assist in any issues that arise to keep both the patient and investigator masked at all times.'}, 'primaryPurpose': 'TREATMENT', 'interventionModel': 'PARALLEL', 'interventionModelDescription': 'Three single groups:\n\n1. Violet + / Lens + Lamp emits violet light and subjects are either wearing no refractive correction or wearing CR-39 lenses that completely transmit violet light.\n2. Violet + / Lens - Lamp emits violet light and subjects are wearing violet-filtering glasses that block out violet light from reaching their eyes.\n3. Violet - / Lens - Lamp does not violet light and subjects are wearing CR-39 lenses that completely transmit violet light.'}, 'enrollmentInfo': {'type': 'ESTIMATED', 'count': 72}}, 'statusModule': {'overallStatus': 'RECRUITING', 'startDateStruct': {'date': '2023-06-07', 'type': 'ACTUAL'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2025-12', 'completionDateStruct': {'date': '2028-01-01', 'type': 'ESTIMATED'}, 'lastUpdateSubmitDate': '2025-12-16', 'studyFirstSubmitDate': '2023-06-13', 'studyFirstSubmitQcDate': '2023-10-25', 'lastUpdatePostDateStruct': {'date': '2025-12-22', 'type': 'ESTIMATED'}, 'studyFirstPostDateStruct': {'date': '2023-10-31', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2027-08-01', 'type': 'ESTIMATED'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Axial Length', 'timeFrame': 'Measured at baseline, and 12 months.', 'description': 'Measurement of the distance between anterior cornea and retina via IOL Master in millimeters.'}, {'measure': 'Refractive Error', 'timeFrame': 'Measured at baseline, and 12 months.', 'description': 'The measurement of power eye measured in diopters.'}, {'measure': 'Visual Acuity', 'timeFrame': 'Measured at baseline, and 12 months.', 'description': 'The measurement of how well a person can see letters at a specific distance, measured in logMAR.'}]}, 'oversightModule': {'oversightHasDmc': False, 'isFdaRegulatedDrug': False, 'isFdaRegulatedDevice': False}, 'conditionsModule': {'keywords': ['Myopia', 'Violet Light'], 'conditions': ['Myopia', 'Phototherapy']}, 'descriptionModule': {'briefSummary': 'The study explores the suppression of myopia via violet light.', 'detailedDescription': 'The study uses violet light-emitting lamps as the variable and regular, white light lamps as the control in assessing whether violet light, especially during over periods of dawn and dusk could help suppress the progression of myopia in developing children.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['CHILD'], 'maximumAge': '12 Years', 'minimumAge': '5 Years', 'healthyVolunteers': True, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* Children must be between 5 to \\<13 years old.\n* Diagnosis of Myopia (ICD-10-CM Diagnosis\n\nCode H52.13) with refractive error:\n\n1. Myopia -1.00D to -6.00D spherical equivalent (SE) in both eyes\n2. Astigmatism \\<=1.50D in both eyes\n3. Anisometropia \\<=1.00D SE • Relocation outside of the CCHMC area within the next 12 months is not anticipated.\n\nExclusion Criteria:\n\nCurrent or previous myopia treatment with atropine, pirenzepine, or other antimuscarinic agents\n\n* Current or previous use of bifocals, progressive addition lenses, or multi-focal contact lenses\n* Current or previous use of orthoK, rigid gas permeable, or other contact lenses being used to reduce myopia progression\n* Current or prior history of manifest strabismus, amblyopia, or nystagmus\n* Abnormality of cornea, lens, central retina, iris, or ciliary body\n* Prior eyelid, strabismus, intraocular, or refractive surgery\n* Down syndrome or cerebral palsy'}, 'identificationModule': {'nctId': 'NCT06110520', 'briefTitle': 'Violet Light for the Suppression of Myopia', 'organization': {'class': 'OTHER', 'fullName': "Children's Hospital Medical Center, Cincinnati"}, 'officialTitle': 'Violet Light for Treatment of Myopia', 'orgStudyIdInfo': {'id': '2021-0289'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'EXPERIMENTAL', 'label': 'Violet + / Lens +', 'description': "Subjects use a violet light emitting lamp (device intervention - minimally invasive as it's simply a source of light) with CR-39 lenses for their refractive correction. The lamp introduces violet light (Violet +) and the CR-39 lenses allow for the transmission of violet light through the lenses (Lens +).", 'interventionNames': ['Device: Violet Light Lamp']}, {'type': 'EXPERIMENTAL', 'label': 'Violet + / Lens -', 'description': "Subjects use a violet light emitting lamp (device intervention - minimally invasive as it's simply a source of light) with polycarbonate lenses for their refractive correction. The lamp introduces violet light (Violet +) while the polycarbonate lenses block the transmission of violet light through the lenses (Lens -).", 'interventionNames': ['Device: Violet Light Lamp']}, {'type': 'PLACEBO_COMPARATOR', 'label': 'Violet - / Lens +', 'description': 'Subjects use a lamp with NO violet light (Violet -) with CR-39 lenses for their refractive correction. CR-39 lenses allow for the transmission of violet light through the lenses (Lens +).', 'interventionNames': ['Device: White Light Lamp']}], 'interventions': [{'name': 'Violet Light Lamp', 'type': 'DEVICE', 'description': 'Medical grade lamps with Violet LEDs enabled', 'armGroupLabels': ['Violet + / Lens +', 'Violet + / Lens -']}, {'name': 'White Light Lamp', 'type': 'DEVICE', 'description': 'Standard bedside lamp with standard 4000K LED light bulb.', 'armGroupLabels': ['Violet - / Lens +']}]}, 'contactsLocationsModule': {'locations': [{'zip': '45209', 'city': 'Cincinnati', 'state': 'Ohio', 'status': 'RECRUITING', 'country': 'United States', 'contacts': [{'name': 'Jillian Eltzroth, MPH', 'role': 'CONTACT', 'email': 'jillian.eltzroth@cchmc.org', 'phone': '937-403-4996'}, {'name': 'Melissa Rice, OD', 'role': 'PRINCIPAL_INVESTIGATOR'}], 'facility': "Cincinnati Children's Hospital Medical Center", 'geoPoint': {'lat': 39.12711, 'lon': -84.51439}}], 'centralContacts': [{'name': 'Jillian Bulman, MPH', 'role': 'CONTACT', 'email': 'jillian.bulman@cchmc.org', 'phone': '9374034996'}, {'name': 'Melissa Rice, OD', 'role': 'CONTACT', 'email': 'Melissa.rice@cchmc.org', 'phone': '513-636-4751'}]}, 'ipdSharingStatementModule': {'ipdSharing': 'NO'}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': "Children's Hospital Medical Center, Cincinnati", 'class': 'OTHER'}, 'responsibleParty': {'type': 'SPONSOR'}}}}