Ignite Creation Date:
2025-12-25 @ 5:09 AM
Ignite Modification Date:
2025-12-26 @ 4:13 AM
Study NCT ID:
NCT01702727
Status:
COMPLETED
Last Update Posted:
2016-11-22
First Post:
2012-08-08
Is NOT Gene Therapy:
False
Has Adverse Events:
False
Brief Title:
I-BiT - Evaluation of a Novel Binocular Treatment System (I-BiTTM) in Children With Amblyopia
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'conditionBrowseModule': {'meshes': [{'id': 'D000550', 'term': 'Amblyopia'}], 'ancestors': [{'id': 'D001927', 'term': 'Brain Diseases'}, {'id': 'D002493', 'term': 'Central Nervous System Diseases'}, {'id': 'D009422', 'term': 'Nervous System Diseases'}, {'id': 'D014786', 'term': 'Vision Disorders'}, {'id': 'D012678', 'term': 'Sensation Disorders'}, {'id': 'D009461', 'term': 'Neurologic Manifestations'}, {'id': 'D005128', 'term': 'Eye Diseases'}, {'id': 'D012816', 'term': 'Signs and Symptoms'}, {'id': 'D013568', 'term': 'Pathological Conditions, Signs and Symptoms'}]}}, 'protocolSection': {'designModule': {'phases': ['PHASE2'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'RANDOMIZED', 'maskingInfo': {'masking': 'SINGLE', 'whoMasked': ['OUTCOMES_ASSESSOR']}, 'primaryPurpose': 'TREATMENT', 'interventionModel': 'PARALLEL'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 75}}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '2012-06'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2016-11', 'completionDateStruct': {'date': '2013-11', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2016-11-21', 'studyFirstSubmitDate': '2012-08-08', 'studyFirstSubmitQcDate': '2012-10-05', 'lastUpdatePostDateStruct': {'date': '2016-11-22', 'type': 'ESTIMATED'}, 'studyFirstPostDateStruct': {'date': '2012-10-08', 'type': 'ESTIMATED'}, 'primaryCompletionDateStruct': {'date': '2013-11', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Change from baseline in visual acuity', 'timeFrame': '6 weeks'}], 'secondaryOutcomes': [{'measure': 'Change from baseline in visual acuity', 'timeFrame': '10 weeks'}]}, 'oversightModule': {'oversightHasDmc': False}, 'conditionsModule': {'keywords': ['Amblyopia', 'I-BiT TM', 'Interactive games', 'Binocular'], 'conditions': ['Amblyopia']}, 'referencesModule': {'references': [{'pmid': '35129211', 'type': 'DERIVED', 'citation': 'Tailor V, Ludden S, Bossi M, Bunce C, Greenwood JA, Dahlmann-Noor A. Binocular versus standard occlusion or blurring treatment for unilateral amblyopia in children aged three to eight years. Cochrane Database Syst Rev. 2022 Feb 7;2(2):CD011347. doi: 10.1002/14651858.CD011347.pub3.'}, {'pmid': '26951772', 'type': 'DERIVED', 'citation': 'Herbison N, MacKeith D, Vivian A, Purdy J, Fakis A, Ash IM, Cobb SV, Eastgate RM, Haworth SM, Gregson RM, Foss AJ. Randomised controlled trial of video clips and interactive games to improve vision in children with amblyopia using the I-BiT system. Br J Ophthalmol. 2016 Nov;100(11):1511-1516. doi: 10.1136/bjophthalmol-2015-307798. Epub 2016 Mar 7.'}, {'pmid': '23688108', 'type': 'DERIVED', 'citation': "Foss AJ, Gregson RM, MacKeith D, Herbison N, Ash IM, Cobb SV, Eastgate RM, Hepburn T, Vivian A, Moore D, Haworth SM; I-BiT Steering group. Evaluation and development of a novel binocular treatment (I-BiT) system using video clips and interactive games to improve vision in children with amblyopia ('lazy eye'): study protocol for a randomised controlled trial. Trials. 2013 May 20;14:145. doi: 10.1186/1745-6215-14-145."}], 'seeAlsoLinks': [{'url': 'http://www.lazy-i-bit.com/', 'label': 'Project website'}]}, 'descriptionModule': {'briefSummary': 'The study aims to determine whether 30 minutes of treatment playing an interactive computer game weekly for 6 weeks, improves visual acuity. The game has been specially configured to ensure the amblyopic eye is preferentially stimulated and the patient wears shutter glasses which manipulate the image seen by each eye in order to provide more information to the amblyopic eye. Patients will be randomised to play the computer game using the I-BiTTM technology, play the computer game but without the I-BiTTM technology, or watch a DVD using the I-BiTTM technology.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['CHILD'], 'maximumAge': '8 Years', 'minimumAge': '4 Years', 'healthyVolunteers': False, 'eligibilityCriteria': "Inclusion criteria:\n\n* Diagnosis of Anisometropic, Strabismic or Mixed Amblyopia as made by an Orthoptist\n* Male or Female\n* Aged 4 - 8 years inclusive.\n* Participant's parent or guardian is willing and able to give informed consent for participation in the study\n\nExclusion criteria:\n\n* Stimulus deprivation amblyopia.\n* Organic lesions of the eye preventing the establishment of good vision (e.g. media opacities, abnormalities in the fundus or optic nerve).\n* Lesions of the brain preventing the establishment of good vision (e.g. cortical visual impairment).\n* Patients diagnosed with Photosensitive Epilepsy\n* Patients diagnosed with or suspected of having Conjunctivitis\n* Loss of suppression at filter 4 or less as measured with the Sbisa Bar\n* Establishment of normal vision by refractive adaptation (wearing glasses after presentation).\n* Inability to comply with the follow up visits required\n* Refusal to accept randomisation\n* Have participated in a previous study examining I-BiT treatment"}, 'identificationModule': {'nctId': 'NCT01702727', 'acronym': 'I-BiT', 'briefTitle': 'I-BiT - Evaluation of a Novel Binocular Treatment System (I-BiTTM) in Children With Amblyopia', 'organization': {'class': 'OTHER', 'fullName': 'Nottingham University Hospitals NHS Trust'}, 'officialTitle': "Evaluation and Development of a Novel Binocular Treatment (I-BiTTM) System Using Video Clips and Interactive Games to Improve Vision in Children With Amblyopia ('Lazy Eye').", 'orgStudyIdInfo': {'id': '10OY006'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'EXPERIMENTAL', 'label': 'I-BiTTM game', 'description': '30 minutes intervention weekly for 6 weeks.', 'interventionNames': ['Device: I-BiTTM game']}, {'type': 'ACTIVE_COMPARATOR', 'label': 'Non-I-BiTTM game', 'description': '30 minutes intervention weekly for 6 weeks.', 'interventionNames': ['Device: Non-I-BiTTM game']}, {'type': 'EXPERIMENTAL', 'label': 'I-BiTTM DVD', 'description': '30 minutes intervention weekly for 6 weeks.', 'interventionNames': ['Device: I-BiTTM DVD']}], 'interventions': [{'name': 'I-BiTTM game', 'type': 'DEVICE', 'description': '30 minutes intervention weekly for 6 weeks.', 'armGroupLabels': ['I-BiTTM game']}, {'name': 'Non-I-BiTTM game', 'type': 'DEVICE', 'description': '30 minutes intervention weekly for 6 weeks.', 'armGroupLabels': ['Non-I-BiTTM game']}, {'name': 'I-BiTTM DVD', 'type': 'DEVICE', 'description': '30 minutes intervention weekly for 6 weeks.', 'armGroupLabels': ['I-BiTTM DVD']}]}, 'contactsLocationsModule': {'locations': [{'zip': 'CB2 0QQ', 'city': 'Cambridge', 'state': 'Cambridgeshire', 'country': 'United Kingdom', 'facility': 'Cambridge University Hospitals NHS Trust', 'geoPoint': {'lat': 52.2, 'lon': 0.11667}}, {'zip': 'NG7 2UH', 'city': 'Nottingham', 'state': 'Nottinghamshire', 'country': 'United Kingdom', 'facility': 'Nottingham University Hospitals NHS Trust', 'geoPoint': {'lat': 52.9536, 'lon': -1.15047}}], 'overallOfficials': [{'name': 'Alexander Foss, BA BMBCh MRCP MRCOphth FRC', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': 'Consultant Ophthalmologist'}]}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Nottingham University Hospitals NHS Trust', 'class': 'OTHER'}, 'collaborators': [{'name': 'Wellcome Trust', 'class': 'OTHER'}], 'responsibleParty': {'type': 'SPONSOR'}}}}