Ignite Creation Date:
2025-12-24 @ 10:09 PM
Ignite Modification Date:
2025-12-25 @ 7:45 PM
Study NCT ID:
NCT05829135
Status:
WITHDRAWN
Last Update Posted:
2025-06-19
First Post:
2022-08-25
Is NOT Gene Therapy:
False
Has Adverse Events:
False
Brief Title:
Improving Glare and Visual Comfort for Patients With Visual Impairment
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'conditionBrowseModule': {'meshes': [{'id': 'D020795', 'term': 'Photophobia'}, {'id': 'D014786', 'term': 'Vision Disorders'}, {'id': 'D015354', 'term': 'Vision, Low'}], 'ancestors': [{'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'}]}}, 'protocolSection': {'designModule': {'phases': ['NA'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'NA', 'maskingInfo': {'masking': 'NONE'}, 'primaryPurpose': 'TREATMENT', 'interventionModel': 'SINGLE_GROUP'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 0}}, 'statusModule': {'whyStopped': 'contact lens no longer available for study', 'overallStatus': 'WITHDRAWN', 'startDateStruct': {'date': '2023-05-01', 'type': 'ACTUAL'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2025-06', 'completionDateStruct': {'date': '2025-06-16', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2025-06-16', 'studyFirstSubmitDate': '2022-08-25', 'studyFirstSubmitQcDate': '2023-04-12', 'lastUpdatePostDateStruct': {'date': '2025-06-19', 'type': 'ACTUAL'}, 'studyFirstPostDateStruct': {'date': '2023-04-25', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2025-06-16', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Glare test', 'timeFrame': 'Measure change from baseline at the 6 week follow-up visit', 'description': 'Measure visual acuity and contrast sensitivity with or without illumination source'}], 'secondaryOutcomes': [{'measure': 'Visual Activities Questionnaire on Glare and Light sensitivity visual functions', 'timeFrame': 'Measure change from baseline at the 6 week follow-up visit', 'description': 'Patient will rate 7 questions on scale ranges from 1-5, higher score indicates more symptoms related to glare and light sensitivity during daily living tasks. Max value 35'}]}, 'oversightModule': {'isUsExport': True, 'oversightHasDmc': False, 'isFdaRegulatedDrug': False, 'isFdaRegulatedDevice': True}, 'conditionsModule': {'conditions': ['Photophobia', 'Visual Impairment', 'Low Vision']}, 'descriptionModule': {'briefSummary': 'To assess the use of contact lenses with transitions technology to improve glare, light sensitivity and overall visual comfort in patients with visual impairment.', 'detailedDescription': 'Acuvue Oasys Contact Lenses with Transitions Light Intelligent Technology can adapt to the amount of visible light in the environment, darkening the lenses in bright sunlight, and returning to regular tint in normal or dim environment.\n\nPurpose of this study is to assess whether individuals with visual impairment may benefit from these lenses to minimize glare, light sensitivity symptoms and improve the overall visual comfort.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT'], 'maximumAge': '64 Years', 'minimumAge': '18 Years', 'healthyVolunteers': False, 'eligibilityCriteria': "Inclusion Criteria:\n\n* Ability to give informed consent\n* Able to speak and read English\n* Experience glare and light sensitivity that impacts patient's daily living activities\n* Have confirmed diagnosis of ocular condition including but not limited to Stargardt's, Cone dystrophy, Cone-rod dystrophy, Albinism, Retinitis Pigmentosa and Achromatopsia.\n* Willing and able to wear the contact lenses as instructed\n\nExclusion Criteria:\n\n* Are pregnant, nursing or planning to become pregnant during the course of the study\n* Have current/recent ocular infection, inflammation, surgery in the past 3 months that contraindicates contact lens wear"}, 'identificationModule': {'nctId': 'NCT05829135', 'briefTitle': 'Improving Glare and Visual Comfort for Patients With Visual Impairment', 'organization': {'class': 'OTHER', 'fullName': 'Nova Southeastern University'}, 'officialTitle': 'Managing Visual Comfort and Function in Patients With Low Vision Using Acuvue Oasys', 'orgStudyIdInfo': {'id': '2020-128'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'EXPERIMENTAL', 'label': 'Treatment group', 'description': 'All participants will be fit with Acuvue Oasys with Transitions.', 'interventionNames': ['Device: Acuvue Oasys with Transitions']}], 'interventions': [{'name': 'Acuvue Oasys with Transitions', 'type': 'DEVICE', 'description': 'soft contact lenses with darkening technology', 'armGroupLabels': ['Treatment group']}]}, 'contactsLocationsModule': {'locations': [{'zip': '33332', 'city': 'Davie', 'state': 'Florida', 'country': 'United States', 'facility': 'Nova Southeastern University', 'geoPoint': {'lat': 26.06287, 'lon': -80.2331}}], 'overallOfficials': [{'name': 'So Yeon Lee, OD', 'role': 'STUDY_CHAIR', 'affiliation': 'Nova Southeastern University'}]}, 'ipdSharingStatementModule': {'ipdSharing': 'NO'}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Nova Southeastern University', 'class': 'OTHER'}, 'collaborators': [{'name': 'American Academy of Optometry', 'class': 'OTHER'}], 'responsibleParty': {'type': 'PRINCIPAL_INVESTIGATOR', 'investigatorTitle': 'Assistant professor', 'investigatorFullName': 'So Yeon Lee', 'investigatorAffiliation': 'Nova Southeastern University'}}}}