Ignite Creation Date:
2025-12-25 @ 3:30 AM
Ignite Modification Date:
2025-12-26 @ 2:11 AM
Study NCT ID:
NCT06914505
Status:
NOT_YET_RECRUITING
Last Update Posted:
2025-04-06
First Post:
2025-03-30
Is NOT Gene Therapy:
False
Has Adverse Events:
False
Brief Title:
Study on the Effectiveness and Safety of VRT in Patients With Visual Field Defects
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}}, 'protocolSection': {'designModule': {'phases': ['NA'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'RANDOMIZED', 'maskingInfo': {'masking': 'NONE'}, 'primaryPurpose': 'TREATMENT', 'interventionModel': 'PARALLEL'}, 'enrollmentInfo': {'type': 'ESTIMATED', 'count': 58}}, 'statusModule': {'overallStatus': 'NOT_YET_RECRUITING', 'startDateStruct': {'date': '2025-04-15', 'type': 'ESTIMATED'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2025-03', 'completionDateStruct': {'date': '2027-12-30', 'type': 'ESTIMATED'}, 'lastUpdateSubmitDate': '2025-04-04', 'studyFirstSubmitDate': '2025-03-30', 'studyFirstSubmitQcDate': '2025-04-04', 'lastUpdatePostDateStruct': {'date': '2025-04-06', 'type': 'ACTUAL'}, 'studyFirstPostDateStruct': {'date': '2025-04-06', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2027-12-30', 'type': 'ESTIMATED'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'visual field mean deviation (MD) value', 'timeFrame': 'A total of 3 examinations were performed during the trial: before treatment, after 1 month of treatment, and after 3 months of treatment.', 'description': 'using the Humphrey Field Analyzer 30-2 test to obtain MD values'}]}, 'oversightModule': {'oversightHasDmc': True, 'isFdaRegulatedDrug': False, 'isFdaRegulatedDevice': False}, 'conditionsModule': {'keywords': ['visual field defect', 'visual restoration therapy'], 'conditions': ['Visual Field Defects', 'Visual Field Loss']}, 'descriptionModule': {'briefSummary': 'The goal of this clinical trial is to learn if visual restoration therapy (VRT) (a type of treatment that aims to improve vision) works to the visual rehabilitation of patients with visual field defects. It will also learn about the safety of VRT. The main questions it aims to answer are:\n\n* Can visual reconstruction therapy help expand the visual field in patients with visual field defects?\n* What medical problems do patients with visual field defects experience during the procedure of VRT? Researchers will look at how patients with visual field defects who use a visual aid in combination with VRT and those who use a visual aid only, compare the visual field expansion at three months to see how well visual reconstruction therapy works.\n\nParticipants will:\n\n* will undergo a specialized visual function assessment and be provided with a pair of appropriate vision aids.\n* Visit the clinic at one month and three months after enrolment for review of visual function and completion of a Chinese-version Low Vision Quality of Life (CLVQOL) questionnaire.\n* Participants receiving VRT will additionally undergo 30 minutes of VRT three times per week for 3 months.\n* Keep a diary for their symptoms and severity and frequency of occurrence during treatment.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'maximumAge': '80 Years', 'minimumAge': '18 Years', 'healthyVolunteers': False, 'eligibilityCriteria': "Inclusion Criteria:\n\n1. Participants with a clear diagnosis of visual field defects.\n2. Participants were between 18 and 80 years of age (including borderline values);\n3. Participants have been treated for their primary disease and conditions are stable;\n4. Participants are not at significant risk of vision loss in the last three months;\n5. Participants do not have planned intraocular surgery during the trial period；\n6. Participants can understand the trial protocol and sign informed consent.\n\nExclusion Criteria:\n\n1. Participants diagnosed as blindness;\n2. Participants with a previous history of seizures or other psychiatric disorders;\n3. Participants with cognitive impairments;\n4. Participant's attention span is less than 30 minutes;\n5. Participants had conditions such as significant ptosis or severe dry eye;\n6. Participants who were in poor general health or who could not cooperate in completing the study protocol for some reasons such as transport."}, 'identificationModule': {'nctId': 'NCT06914505', 'briefTitle': 'Study on the Effectiveness and Safety of VRT in Patients With Visual Field Defects', 'organization': {'class': 'OTHER', 'fullName': 'Xuanwu Hospital, Beijing'}, 'officialTitle': 'Study on the Effectiveness and Safety of Visual Restoration Therapy in the Active Rehabilitation of Patients With Visual Field Defects', 'orgStudyIdInfo': {'id': 'LYS2024211001'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'EXPERIMENTAL', 'label': 'VRT treatment group', 'description': 'The participants will be provided with a pair of appropriate vision aids and will undergo 3 times 30-minute visual restoration therapy (VRT) training per week for three months.', 'interventionNames': ['Behavioral: visual restoration therapy']}, {'type': 'NO_INTERVENTION', 'label': 'control group', 'description': 'Participants will be provided with a pair of appropriate vision aids, however without any visual treatment.'}], 'interventions': [{'name': 'visual restoration therapy', 'type': 'BEHAVIORAL', 'otherNames': ['photostimulation therapy'], 'description': "In this study, we used a reversing checkerboard pattern as a stimulus and acted on the relatively dark spots area of the patient's visual field.", 'armGroupLabels': ['VRT treatment group']}]}, 'contactsLocationsModule': {'centralContacts': [{'name': 'Zhen Li, MD. and PHD.', 'role': 'CONTACT', 'email': 'zhenli_xwyy@163.com', 'phone': '+86 13581646689'}], 'overallOfficials': [{'name': 'Zhen Li, MD. and PHD.', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': 'Ophthalmology Department, Xuanwu Hospital，Capital Medical University'}]}, 'ipdSharingStatementModule': {'ipdSharing': 'NO'}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Xuanwu Hospital, Beijing', 'class': 'OTHER'}, 'responsibleParty': {'type': 'SPONSOR'}}}}