Ignite Creation Date:
2025-12-24 @ 11:58 PM
Ignite Modification Date:
2025-12-25 @ 9:56 PM
Study NCT ID:
NCT06771258
Status:
NOT_YET_RECRUITING
Last Update Posted:
2025-01-13
First Post:
2024-12-20
Is NOT Gene Therapy:
False
Has Adverse Events:
False
Brief Title:
Red Light Childhood Myopia Proof-of-concept
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'}]}, 'interventionBrowseModule': {'meshes': [{'id': 'D010778', 'term': 'Photochemotherapy'}], 'ancestors': [{'id': 'D003131', 'term': 'Combined Modality Therapy'}, {'id': 'D013812', 'term': 'Therapeutics'}, {'id': 'D004358', 'term': 'Drug Therapy'}, {'id': 'D010789', 'term': 'Phototherapy'}]}}, 'protocolSection': {'designModule': {'phases': ['NA'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'NON_RANDOMIZED', 'maskingInfo': {'masking': 'NONE'}, 'primaryPurpose': 'BASIC_SCIENCE', 'interventionModel': 'SEQUENTIAL'}, 'enrollmentInfo': {'type': 'ESTIMATED', 'count': 24}}, 'statusModule': {'overallStatus': 'NOT_YET_RECRUITING', 'startDateStruct': {'date': '2025-02-01', 'type': 'ESTIMATED'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2025-01', 'completionDateStruct': {'date': '2026-02-01', 'type': 'ESTIMATED'}, 'lastUpdateSubmitDate': '2025-01-09', 'studyFirstSubmitDate': '2024-12-20', 'studyFirstSubmitQcDate': '2025-01-09', 'lastUpdatePostDateStruct': {'date': '2025-01-13', 'type': 'ACTUAL'}, 'studyFirstPostDateStruct': {'date': '2025-01-13', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2026-02-01', 'type': 'ESTIMATED'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Axial length', 'timeFrame': '3 months', 'description': 'The researchers will measure the length of the eyeballs using an optical biometer; these are the most sensitive outcome measure in myopia studies, and the least invasive measurement method.'}], 'secondaryOutcomes': [{'measure': 'Spherical equivalent', 'timeFrame': '3 months', 'description': 'The team will measure the refractive error (prescription for spectacles) using an open-view autorefractor, as a secondary measure of myopia progression.'}, {'measure': 'Subfoveal choroidal thickness', 'timeFrame': '3 months', 'description': 'The team will acquire an optical coherence tomography scan. On the scan, the researchers will measure the choroidal thickness, which is frequently used as a proxy measure of the treatment effect of interventions to slow myopia progression. The choroid is a vascular layer underneath the retina at the back of the eye.'}, {'measure': 'Colour contrast sensitivity', 'timeFrame': '3 months', 'description': 'As a safety measure, the researchers will measure colour contrast sensitivity on a computer-screen, showing participants coloured symbols on a grey background. This is the most sensitive test for photoreceptor health, the layer of cells in the retina which change light signals to electrical signals.'}, {'measure': 'Visual acuity', 'timeFrame': '3 months', 'description': "As a secondary safety outcome, the researchers will measure the participant's visual acuity, using a test where participants read letters of reducing size on a chart."}, {'measure': 'Tolerability/usability', 'timeFrame': '3 months', 'description': 'The researchers will ask participants open-ended questions about their thoughts and experience with using red-light treatment, and about easier ways for children to use it.'}]}, 'oversightModule': {'isUsExport': False, 'oversightHasDmc': False, 'isFdaRegulatedDrug': False, 'isFdaRegulatedDevice': False}, 'conditionsModule': {'conditions': ['Myopia']}, 'descriptionModule': {'briefSummary': 'In this project the research team will begin to find out whether shining a red LED light at the eyes can slow down the worsening of short-sightedness in children.\n\nThis is important, because short-sightedness now starts at a younger age and worsens faster than in the past. Many people are at risk of permanently losing their eyesight in middle-age because of short-sightedness.\n\nThe researchers plan to use red LED light, which is safe to use. Red-light treatment improves the blood flow at the back of the eye, in a layer called "choroid", which can be measured on eye-scans. The team have done a study with healthy adults, which showed that red-light is safe and gently improves the blood flow at the back of the eye. In adults, this has no effect on myopia, because their eyes are fully grown. In children, red-light may slow down myopia, and in this project, the researchers want to find out which level of red-light is needed to have this effect. The researchers will ask 24 children age 5-12 years to use red-light for three minutes twice a day for three months. Three will be 4 groups of children, and each group will use a different level of brightness. The researchers will measure the eye length and the thickness of the choroid at the start and 1 and 3 months later and compare the change in eye length between the different groups.\n\nIn practice, children will need to use the treatment for several years. The researchers will use the results of this study to prepare a longer study with more children.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['CHILD'], 'maximumAge': '12 Years', 'minimumAge': '5 Years', 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* short-sightedness between -1.00D and -6.00 diopters in both eyes\n* best-corrected visual acuity 0.1 logMAR or better in both eyes\n\nExclusion Criteria:\n\n* underlying condition/syndrome causing myopia\n* previous or current myopia-modifying treatment\n* abnormal ocular refractive anatomy or previous intraocular or ocular surgery'}, 'identificationModule': {'nctId': 'NCT06771258', 'briefTitle': 'Red Light Childhood Myopia Proof-of-concept', 'organization': {'class': 'OTHER', 'fullName': 'University College, London'}, 'officialTitle': 'What Effect Does Looking At Red Light Have on the Eye in Children and Young People? - a Proof-of-concept Study', 'orgStudyIdInfo': {'id': 'EDGE 166432'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'ACTIVE_COMPARATOR', 'label': 'Intensity 1', 'description': 'Children will use red-light of the lowest intensity, twice daily for 3 minutes, at home', 'interventionNames': ['Other: Red Light (PDT)']}, {'type': 'ACTIVE_COMPARATOR', 'label': 'Intensity 2', 'description': 'Children will use red-light of low intensity, but slightly higher than in the Intensity 1 arm, twice daily for 3 minutes, at home', 'interventionNames': ['Other: Red Light (PDT)']}, {'type': 'ACTIVE_COMPARATOR', 'label': 'Intensity 3', 'description': 'Children will use red-light of medium intensity, slightly higher than in the Intensity 2 arm, twice daily for 3 minutes, at home', 'interventionNames': ['Other: Red Light (PDT)']}, {'type': 'ACTIVE_COMPARATOR', 'label': 'Intensity 4', 'description': 'Children will use red-light of medium intensity, slightly higher than in the Intensity 3 arm, twice daily for 3 minutes, at home', 'interventionNames': ['Other: Red Light (PDT)']}], 'interventions': [{'name': 'Red Light (PDT)', 'type': 'OTHER', 'description': 'Red LED light', 'armGroupLabels': ['Intensity 1', 'Intensity 2', 'Intensity 3', 'Intensity 4']}]}, 'contactsLocationsModule': {'locations': [{'zip': 'EC1V 9EL', 'city': 'London', 'state': 'London', 'country': 'United Kingdom', 'contacts': [{'name': 'Annegret Dahlmann-Noor, PhD', 'role': 'CONTACT', 'email': 'anngret.dahlmann@ucl.ac.uk', 'phone': '020 7253 3411'}, {'name': 'Annegret Dahlmann-Noor, PhD', 'role': 'CONTACT'}], 'facility': 'University College London', 'geoPoint': {'lat': 51.50853, 'lon': -0.12574}}], 'centralContacts': [{'name': 'Annegret Dahlmann-Noor, PhD', 'role': 'CONTACT', 'email': 'anngret.dahlmann@ucl.ac.uk', 'phone': '020 7253 3411'}], 'overallOfficials': [{'name': 'Annegret Dahlmann-Noor, PhD', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': 'UCL'}]}, 'ipdSharingStatementModule': {'ipdSharing': 'UNDECIDED'}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'University College, London', 'class': 'OTHER'}, 'responsibleParty': {'type': 'SPONSOR'}}}}