Ignite Creation Date:
2025-12-24 @ 10:01 PM
Ignite Modification Date:
2026-02-20 @ 10:08 PM
Study NCT ID:
NCT04281732
Status:
UNKNOWN
Last Update Posted:
2020-02-24
First Post:
2019-08-12
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Visual Performance Measures in a Virtual Reality Environment for Assessing Clinical Trial Outcomes in Those With Severely Reduced Vision
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'conditionBrowseModule': {'meshes': [{'id': 'D015354', 'term': 'Vision, Low'}, {'id': 'D012174', 'term': 'Retinitis Pigmentosa'}, {'id': 'D000080362', 'term': 'Stargardt Disease'}, {'id': 'C535805', 'term': 'Stargardt disease 3'}, {'id': 'C535521', 'term': 'Stargardt disease 4'}, {'id': 'D000417', 'term': 'Albinism'}], 'ancestors': [{'id': 'D014786', 'term': 'Vision Disorders'}, {'id': 'D012678', 'term': 'Sensation Disorders'}, {'id': 'D009461', 'term': 'Neurologic Manifestations'}, {'id': 'D009422', 'term': 'Nervous System Diseases'}, {'id': 'D005128', 'term': 'Eye Diseases'}, {'id': 'D012816', 'term': 'Signs and Symptoms'}, {'id': 'D013568', 'term': 'Pathological Conditions, Signs and Symptoms'}, {'id': 'D015785', 'term': 'Eye Diseases, Hereditary'}, {'id': 'D058499', 'term': 'Retinal Dystrophies'}, {'id': 'D012162', 'term': 'Retinal Degeneration'}, {'id': 'D012164', 'term': 'Retinal Diseases'}, {'id': 'D030342', 'term': 'Genetic Diseases, Inborn'}, {'id': 'D009358', 'term': 'Congenital, Hereditary, and Neonatal Diseases and Abnormalities'}, {'id': 'D008268', 'term': 'Macular Degeneration'}, {'id': 'D000592', 'term': 'Amino Acid Metabolism, Inborn Errors'}, {'id': 'D008661', 'term': 'Metabolism, Inborn Errors'}, {'id': 'D012873', 'term': 'Skin Diseases, Genetic'}, {'id': 'D017496', 'term': 'Hypopigmentation'}, {'id': 'D010859', 'term': 'Pigmentation Disorders'}, {'id': 'D012871', 'term': 'Skin Diseases'}, {'id': 'D017437', 'term': 'Skin and Connective Tissue Diseases'}, {'id': 'D008659', 'term': 'Metabolic Diseases'}, {'id': 'D009750', 'term': 'Nutritional and Metabolic Diseases'}]}}, 'documentSection': {'largeDocumentModule': {'largeDocs': [{'date': '2016-12-09', 'size': 1687903, 'label': 'Study Protocol and Statistical Analysis Plan', 'hasIcf': False, 'hasSap': True, 'filename': 'Prot_SAP_000.pdf', 'typeAbbrev': 'Prot_SAP', 'uploadDate': '2019-03-04T09:05', 'hasProtocol': True}]}}, 'protocolSection': {'designModule': {'studyType': 'OBSERVATIONAL', 'designInfo': {'timePerspective': 'PROSPECTIVE', 'observationalModel': 'COHORT'}, 'enrollmentInfo': {'type': 'ESTIMATED', 'count': 20}, 'patientRegistry': False}, 'statusModule': {'overallStatus': 'UNKNOWN', 'lastKnownStatus': 'RECRUITING', 'startDateStruct': {'date': '2018-10-01', 'type': 'ACTUAL'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2020-02', 'completionDateStruct': {'date': '2020-12-31', 'type': 'ESTIMATED'}, 'lastUpdateSubmitDate': '2020-02-21', 'studyFirstSubmitDate': '2019-08-12', 'studyFirstSubmitQcDate': '2020-02-21', 'lastUpdatePostDateStruct': {'date': '2020-02-24', 'type': 'ACTUAL'}, 'studyFirstPostDateStruct': {'date': '2020-02-24', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2020-09-30', 'type': 'ESTIMATED'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Test repeatability', 'timeFrame': 'All statistical analysis will take place once all data collection has ended, average 1 year.', 'description': 'Bland and Altman analysis will be used to investigate the repeatability of the tests between visit 1 and visit 2.'}], 'secondaryOutcomes': [{'measure': 'Ease of use and acceptability questionnaire', 'timeFrame': 'Responses from all participants will be collated and summarised at the end of the study, average 1 year.', 'description': 'Modified from Tay et al, Br J Ophthalmol 2004;88:719-720\n\nAsk the following questions for virtual reality test:\n\n1. Was the test comfortable? If no- How?\n2. Was the test too long?\n3. How did you find the test? Would you describe it as easy or difficult? If you found it difficult- how?\n4. How would you feel if you knew you had to perform this test at every clinic appointment?\n5. Do you have any other comments about the test?'}]}, 'oversightModule': {'oversightHasDmc': False, 'isFdaRegulatedDrug': False, 'isFdaRegulatedDevice': False}, 'conditionsModule': {'keywords': ['Virtual Reality', 'Quality of life'], 'conditions': ['Low Vision', 'Retinitis Pigmentosa', 'Stargardt Disease 1', 'Stargardt Disease 3', 'Stargardt Disease 4', 'Albinism']}, 'descriptionModule': {'briefSummary': 'Purpose:\n\nTo validate a newly developed battery of performance-based tests of visual function to be presented using virtual reality. The tests are intended as potential outcome measures for clinical trials of treatments of eye disease: they measure visual performance in patients with low vision on visual tasks that a relevant for daily life.', 'detailedDescription': "Aims of the Research Project:\n\n1. To validate a new virtual reality (VR)-based battery of performance-based tests of visual function that are relevant for patients' daily lives.\n2. To quantify the reproducibility of the performance-based tests.\n3. To gather acceptability and ease-of-use data from patients."}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT'], 'maximumAge': '50 Years', 'minimumAge': '20 Years', 'samplingMethod': 'NON_PROBABILITY_SAMPLE', 'studyPopulation': "Patients with Stargardt's disease, advanced retinitis pigmentosa and Albinism.", 'eligibilityCriteria': "Inclusion Criteria:\n\n1. Male and female participants\n2. Age 20-50\n3. Bilateral sight impairment due to Stargardt's disease, retinitis pigmentosa or albinism.\n4. Sight impairment criteria are as follows:\n\n * Visual acuity of 3 / 60 to 6 / 60 with a full field of vision.\n * Visual acuity of up to 6 / 24 with a moderate reduction of field of vision\n\nExclusion Criteria:\n\n1. Any physical impairment that would make use of the virtual reality headset difficult or unsafe.\n2. A history of vertigo or dizziness."}, 'identificationModule': {'nctId': 'NCT04281732', 'briefTitle': 'Visual Performance Measures in a Virtual Reality Environment for Assessing Clinical Trial Outcomes in Those With Severely Reduced Vision', 'organization': {'class': 'OTHER', 'fullName': "Queen's University, Belfast"}, 'officialTitle': 'Visual Performance Measures in a Virtual Reality Environment for Assessing Clinical Trial Outcomes in Those With Severely Reduced Vision', 'orgStudyIdInfo': {'id': '17/NI/0002'}}, 'armsInterventionsModule': {'interventions': [{'name': 'Virtual Reality Headset based tests', 'type': 'DEVICE', 'description': 'Visual task tests based on Oculus Rift'}]}, 'contactsLocationsModule': {'locations': [{'zip': 'BT9 7AB', 'city': 'Belfast', 'state': 'Northern Ireland', 'status': 'RECRUITING', 'country': 'United Kingdom', 'contacts': [{'name': 'Ruth Hogg', 'role': 'CONTACT', 'email': 'r.e.hogg@qub.ac.uk', 'phone': '028 90635018'}], 'facility': 'NI Clinical Research Facility', 'geoPoint': {'lat': 54.59682, 'lon': -5.92541}}], 'centralContacts': [{'name': 'Ruth Hogg, PhD', 'role': 'CONTACT', 'email': 'r.e.hogg@qub.ac.uk', 'phone': '02890971654'}, {'name': 'Lucie Dalton, BSc', 'role': 'CONTACT', 'email': 'l.dalton@qub.ac.uk'}], 'overallOfficials': [{'name': 'Ruth E Hogg, PhD', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': "Queen's University, Belfast"}]}, 'ipdSharingStatementModule': {'ipdSharing': 'NO'}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': "Queen's University, Belfast", 'class': 'OTHER'}, 'collaborators': [{'name': 'University of Sussex', 'class': 'OTHER'}], 'responsibleParty': {'type': 'PRINCIPAL_INVESTIGATOR', 'investigatorTitle': 'Principal Investigator', 'investigatorFullName': 'Ruth Hogg', 'investigatorAffiliation': "Queen's University, Belfast"}}}}