Ignite Creation Date:
2025-12-24 @ 10:15 PM
Ignite Modification Date:
2026-03-03 @ 9:16 PM
Study NCT ID:
NCT06428435
Status:
COMPLETED
Last Update Posted:
2025-07-18
First Post:
2024-05-20
Is Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Next Generation Home Vision Assessment
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'}]}, 'interventionBrowseModule': {'meshes': [{'id': 'D014787', 'term': 'Vision Tests'}], 'ancestors': [{'id': 'D003941', 'term': 'Diagnostic Techniques, Ophthalmological'}, {'id': 'D019937', 'term': 'Diagnostic Techniques and Procedures'}, {'id': 'D003933', 'term': 'Diagnosis'}]}}, 'protocolSection': {'designModule': {'studyType': 'OBSERVATIONAL', 'designInfo': {'timePerspective': 'PROSPECTIVE', 'observationalModel': 'OTHER'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 206}, 'patientRegistry': False}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '2023-03-01', 'type': 'ACTUAL'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2025-07', 'completionDateStruct': {'date': '2024-12-31', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2025-07-15', 'studyFirstSubmitDate': '2024-05-20', 'studyFirstSubmitQcDate': '2024-05-20', 'lastUpdatePostDateStruct': {'date': '2025-07-18', 'type': 'ACTUAL'}, 'studyFirstPostDateStruct': {'date': '2024-05-24', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2024-08-31', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Acuity', 'timeFrame': '2 weeks', 'description': 'Home versus Remote Acuity difference'}], 'secondaryOutcomes': [{'measure': 'Colour Vision', 'timeFrame': '2 weeks', 'description': 'Digital versus in clinic standard'}, {'measure': 'Visual field', 'timeFrame': '2 weeks', 'description': 'Digital versus in clinic standard'}]}, 'oversightModule': {'isUsExport': False, 'oversightHasDmc': False, 'isFdaRegulatedDrug': False, 'isFdaRegulatedDevice': False}, 'conditionsModule': {'keywords': ['teleophthalmology', 'remote consultations', 'amblyopia', 'paediatrics', 'telemedicine', 'digital health'], 'conditions': ['Amblyopia', 'Vision; Low, One Eye (Other Eye Normal)', 'Pediatric Disorder']}, 'descriptionModule': {'briefSummary': 'Comparison of live remote paediatric digital vision testing outcomes versus face to face appointments in orthoptic clinic', 'detailedDescription': 'Study Overview The "Next Generation Home Vision Assessment" study aims to evaluate the feasibility and accuracy of conducting vision assessments at home using a web-based platform. This prospective, non-interventional, multi-center study will compare home-based vision tests with traditional hospital-based assessments.\n\nStudy Background The COVID-19 pandemic has significantly limited patients\' ability to attend in-person eye clinic appointments, impacting vision assessments and management. Ramifications in delays continue to have an impact.\n\nStudy Rationale This study seeks to validate home-based vision assessments against standard in-person evaluations to ensure patients can be effectively monitored and managed remotely. The use of a web-based platform for vision tests could offer a reliable alternative, reducing hospital visits and maintaining care standards.\n\nObjectives and Endpoints Primary Objective: To compare the accuracy of home-based visual acuity tests to hospital-based assessments.\n\nSecondary Objectives: To evaluate other aspects of visual function (e.g., visual fields, color vision, contrast sensitivity) and measure patient engagement and test duration.\n\nStudy Design Type: Prospective, non-interventional Participants: Adults and children attending hospital eye services Sample Size: 360 completed assessments Duration: Minimum of 6 months\n\nStudy Procedure Participants attending hospital eye services will be recruited and provided with a patient information leaflet. Those willing to participate will undergo a visual acuity test +/- additional vision tests (secondary outcomes) during a video consultation. Hospital-based assessment results will be compared to home-based test results to determine accuracy.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['CHILD', 'ADULT', 'OLDER_ADULT'], 'maximumAge': '90 Years', 'minimumAge': '0 Months', 'samplingMethod': 'NON_PROBABILITY_SAMPLE', 'studyPopulation': 'Patients attending hospital and at home', 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion criteria\n\n\\- Patients attending hospital eye services will be eligible for enrolment.\n\nAge: less than 90 years old English speakers, as no available resource for translation services. Parents / patients must be able to provide consent Patient must be able to communicate what he / she sees on a vision assessment chart.\n\nMust have access to smartphone, tablet or home computer that can run video conferencing platforms.\n\nExclusion criteria\n\nNon English speakers or lack of ability to consent Inability to communicate what is seen on a chart, or inability to complete a preferential looking visual acuity test Inability to connect to a video conferencing platform.'}, 'identificationModule': {'nctId': 'NCT06428435', 'acronym': 'NGHVA', 'briefTitle': 'Next Generation Home Vision Assessment', 'organization': {'class': 'OTHER_GOV', 'fullName': 'NHS Forth Valley'}, 'officialTitle': 'Next Generation Home Vision Assessment', 'orgStudyIdInfo': {'id': 'FV1275'}, 'secondaryIdInfos': [{'id': '286078', 'type': 'OTHER', 'domain': 'IRAS Project ID'}, {'id': '20/WM/0285', 'type': 'OTHER', 'domain': 'REC Number'}, {'id': '136640', 'type': 'OTHER', 'domain': 'Edge ID'}]}, 'armsInterventionsModule': {'armGroups': [{'label': 'Ibis', 'description': 'Tested with Ibis technology', 'interventionNames': ['Diagnostic Test: Vision Test']}, {'label': 'Optonet', 'description': 'Tested with Optonet Technology', 'interventionNames': ['Diagnostic Test: Vision Test']}], 'interventions': [{'name': 'Vision Test', 'type': 'DIAGNOSTIC_TEST', 'description': 'Remote vision testing via digital screen', 'armGroupLabels': ['Ibis', 'Optonet']}]}, 'contactsLocationsModule': {'locations': [{'zip': 'B4 6NH', 'city': 'Birmingham', 'state': 'Birmingham', 'country': 'United Kingdom', 'facility': 'Birmingham Womens and Childens Hospital', 'geoPoint': {'lat': 52.48142, 'lon': -1.89983}}, {'zip': 'IV2 3JH', 'city': 'Inverness', 'state': 'Inverness', 'country': 'United Kingdom', 'facility': 'NHS Fife', 'geoPoint': {'lat': 57.47908, 'lon': -4.22398}}, {'zip': 'FK1 5SU', 'city': 'Falkirk', 'state': 'Stirlingshire', 'country': 'United Kingdom', 'facility': 'NHS Forth Valley Research & Development Office', 'geoPoint': {'lat': 56.0021, 'lon': -3.78535}}, {'city': 'Glasgow', 'country': 'United Kingdom', 'facility': 'NHS Greater Glasgow & Clyde', 'geoPoint': {'lat': 55.86515, 'lon': -4.25763}}], 'overallOfficials': [{'name': 'Iain Livingstone, MBChB MD', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': 'NHS Forth Valley'}]}, 'ipdSharingStatementModule': {'timeFrame': 'Aim: 12 months post completion of study', 'ipdSharing': 'YES', 'description': 'Anonymised data will be made available as part of publication', 'accessCriteria': 'Open Access'}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'NHS Forth Valley', 'class': 'OTHER_GOV'}, 'collaborators': [{'name': "Birmingham Children's Hospital", 'class': 'OTHER'}, {'name': 'NHS Fife', 'class': 'OTHER_GOV'}, {'name': 'NHS Highland', 'class': 'OTHER'}], 'responsibleParty': {'type': 'SPONSOR'}}}}