Ignite Creation Date:
2025-12-25 @ 12:33 AM
Ignite Modification Date:
2026-01-27 @ 2:31 AM
Study NCT ID:
NCT06529367
Status:
RECRUITING
Last Update Posted:
2024-08-01
First Post:
2024-07-27
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Comparing a Home Vision Self-Assessment Test to Office-Based Snellen Visual Acuity in Myopic Children
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}}, 'protocolSection': {'designModule': {'studyType': 'OBSERVATIONAL', 'designInfo': {'timePerspective': 'CROSS_SECTIONAL', 'observationalModel': 'COHORT'}, 'enrollmentInfo': {'type': 'ESTIMATED', 'count': 80}, 'patientRegistry': False}, 'statusModule': {'overallStatus': 'RECRUITING', 'startDateStruct': {'date': '2024-07-31', 'type': 'ACTUAL'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2024-07', 'completionDateStruct': {'date': '2025-02-01', 'type': 'ESTIMATED'}, 'lastUpdateSubmitDate': '2024-07-31', 'studyFirstSubmitDate': '2024-07-27', 'studyFirstSubmitQcDate': '2024-07-30', 'lastUpdatePostDateStruct': {'date': '2024-08-01', 'type': 'ACTUAL'}, 'studyFirstPostDateStruct': {'date': '2024-07-31', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2025-02-01', 'type': 'ESTIMATED'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Agreement of visual acuity between office and home', 'timeFrame': 'immediately after test performing', 'description': 'Agreement of visual acuity between office and home will be assessed.'}]}, 'oversightModule': {'isFdaRegulatedDrug': False, 'isFdaRegulatedDevice': False}, 'conditionsModule': {'conditions': ['Home Vision', 'Office-Based Snellen Visual Acuity', 'Myopic Children']}, 'descriptionModule': {'briefSummary': 'This study aims to compare a home vision self-assessment test to office-based Snellen visual acuity in myopic children.', 'detailedDescription': "Visual impairment is an important public health issue worldwide, with a heavy socioeconomic burden. More than 400 million people globally have mild to severe visual impairment.\n\nVisual acuity (VA) screening is the most basic part of ophthalmic examination. Home vision screening tests have become an important way to obtain a measure of an individual's VA without an office-based clinic visit. Knowing a patient's VA can help ophthalmologists remotely triage acute calls, monitor visual recovery after medical or surgical interventions, and ensure visual stability in follow-up telemedicine visits.\n\nHome vision screening tests have become an important way to obtain a measure of an individual's VA without an office-based clinic visit. Numerous electronic home vision assessment tools exist, but many of these are used through applications on mobile or tablet devices."}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['CHILD', 'ADULT'], 'maximumAge': '18 Years', 'samplingMethod': 'NON_PROBABILITY_SAMPLE', 'studyPopulation': 'This cross-sectional study will be carried out on 80 myopic children aged ≤ 18 years, who completed the home visual acuity test and have a subsequent office-based VA test at South Valley University for a period from July 2024 to January 2025 after approval from the institutional ethical committee.', 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* Age ≤ 18 years.\n* Both sexes.\n* Patients who completed the home visual acuity test and have a subsequent office-based visual acuity test.\n\nExclusion Criteria:\n\n* Last in-office visual acuity of 20/125 or worse in both eyes (to allow for a buffer of at least 2 lines of vision from the upper limit of 20/200 on the home vision assessment).\n* Lack of access to MyChart.\n* History of keratopathy, cataract, glaucoma, retinal detachment, neuro-ophthalmic disease, or other eye diseases.\n* History of ophthalmic surgery or trauma.\n* History of systemic diseases.\n* Severe psychological or psychiatric diseases.'}, 'identificationModule': {'nctId': 'NCT06529367', 'briefTitle': 'Comparing a Home Vision Self-Assessment Test to Office-Based Snellen Visual Acuity in Myopic Children', 'organization': {'class': 'OTHER', 'fullName': 'South Valley University'}, 'officialTitle': 'Comparing a Home Vision Self-Assessment Test to Office-Based Snellen Visual Acuity in Myopic Children', 'orgStudyIdInfo': {'id': 'SVU\\MED\\OPH026/4/24/7/887'}}, 'armsInterventionsModule': {'armGroups': [{'label': 'Visual Acuity Testing group', 'description': 'Home vision assessment will be conducted using the "Letter Distance Chart" PDF document, a modified Early Treatment of Diabetic Retinopathy Study (ETDRS) chart for testing at 5 or 10 feet, and released for public use.\n\nPatients will be asked to use the 5-foot distance for standardization, which allows for visual acuity assessment from 20/16 to 20/200.\n\nPatients will be asked to wear their current corrective lens for distance, to take the test at home in a place with good lighting, and to test each eye separately.\n\nOffice-based vision testing will be performed by a trained ophthalmic technician in a dimmed room with the Snellen chart illuminated on a screen. Patients will be asked to wear their current corrective lens for distance and an eye occluder will be used to test each eye separately.', 'interventionNames': ['Other: Snellen chart']}], 'interventions': [{'name': 'Snellen chart', 'type': 'OTHER', 'description': 'Patients will be asked to use the 5 feet distance for standardization, which allows for visual acuity assessment from 20/16 to 20/200.\n\nPatients will be asked to wear their current corrective lens for distance, to take the test at home in a place with good lighting and to test each eye separately.\n\nOffice-based vision testing will be performed by a trained ophthalmic technician in a dimmed room with the Snellen chart illuminated on a screen. Patients will be asked to wear their current corrective lens for distance and an eye occluder will be used to test each eye separately.', 'armGroupLabels': ['Visual Acuity Testing group']}]}, 'contactsLocationsModule': {'locations': [{'zip': '83523', 'city': 'Qina', 'status': 'RECRUITING', 'country': 'Egypt', 'contacts': [{'name': 'Ahmed A Amer, MD', 'role': 'CONTACT', 'email': 'ahmedali.ophth@gmail.com', 'phone': '00201011827000'}], 'facility': 'South Valley University', 'geoPoint': {'lat': 26.16418, 'lon': 32.72671}}], 'centralContacts': [{'name': 'Ahmed A Amer, MD', 'role': 'CONTACT', 'email': 'ahmedali.ophth@gmail.com', 'phone': '00201011827000'}]}, 'ipdSharingStatementModule': {'infoTypes': ['STUDY_PROTOCOL'], 'timeFrame': 'After the end of study for one year.', 'ipdSharing': 'YES', 'description': 'The data will be available upon a reasonable request from the corresponding author after the end of study for one year.', 'accessCriteria': 'The data will be available upon a reasonable request from the corresponding author.'}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'South Valley University', 'class': 'OTHER'}, 'responsibleParty': {'type': 'PRINCIPAL_INVESTIGATOR', 'investigatorTitle': 'Lecturer of Ophthalmology, Faculty of Medicine, South Valley University, Qena, Egypt.', 'investigatorFullName': 'Ahmed Ali Amer', 'investigatorAffiliation': 'South Valley University'}}}}