Ignite Creation Date:
2025-12-25 @ 12:39 AM
Ignite Modification Date:
2026-01-02 @ 12:16 AM
Study NCT ID:
NCT05732467
Status:
UNKNOWN
Last Update Posted:
2023-02-17
First Post:
2023-02-08
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Effectiveness of Virtual Reality Training in Amblyopia
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'}]}}, 'protocolSection': {'designModule': {'phases': ['NA'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'RANDOMIZED', 'maskingInfo': {'masking': 'NONE'}, 'primaryPurpose': 'TREATMENT', 'interventionModel': 'PARALLEL'}, 'enrollmentInfo': {'type': 'ESTIMATED', 'count': 90}}, 'statusModule': {'overallStatus': 'UNKNOWN', 'lastKnownStatus': 'RECRUITING', 'startDateStruct': {'date': '2022-11-14', 'type': 'ACTUAL'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2023-02', 'completionDateStruct': {'date': '2024-06', 'type': 'ESTIMATED'}, 'lastUpdateSubmitDate': '2023-02-16', 'studyFirstSubmitDate': '2023-02-08', 'studyFirstSubmitQcDate': '2023-02-16', 'lastUpdatePostDateStruct': {'date': '2023-02-17', 'type': 'ACTUAL'}, 'studyFirstPostDateStruct': {'date': '2023-02-17', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2023-07', 'type': 'ESTIMATED'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Best corrected visual acuity', 'timeFrame': '16 weeks'}], 'secondaryOutcomes': [{'measure': 'Near stereopsis', 'timeFrame': '16 weeks'}, {'measure': 'contrast sensitivity', 'timeFrame': '16 weeks'}]}, 'oversightModule': {'isFdaRegulatedDrug': False, 'isFdaRegulatedDevice': False}, 'conditionsModule': {'keywords': ['amblyopia', 'virtual reality'], 'conditions': ['Amblyopia']}, 'descriptionModule': {'briefSummary': 'The goal of this clinical trial is to evaluate the efficacy and safety of visual function training software (model: SJ-JRS2021) in the treatment of mild to moderate amblyopia in children. The main questions it aims to answer are:\n\n* Whether virtual reality training is more effective than occlusion therapy\n* Safety of virtual reality training in amblyopia treatment If participants have refractive problems, correct the refraction first and wear corrective glasses. The experimental group will be treated using visual function training therapy software (model: SJ-JRS2021). The control group will be treated with occlusion therapy covering the contralateral eye for 2 hours a day. Researchers will compare experimental group with control group to see if the experimental group has better corrected vision recovery.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['CHILD'], 'maximumAge': '7 Years', 'minimumAge': '4 Years', 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* Age 4-7 years old (including 4 and 7 years old), both sexes;\n* Monocular amblyopia was diagnosed;\n* The corrected visual acuity of amblyopia is between 0.2 (inclusive) and 0.6, and the binocular visual difference is more than 2 lines;\n* The guardian of the subject can understand the purpose of the trial and sign the informed consent. The subject can cooperate with the treatment and related ophthalmic examination\n\nExclusion Criteria:\n\n* The subject has tumor, heart disease, hypertension and epilepsy;\n* The subject has an implanted electronic device, such as a pacemaker;\n* The subject has suffered from mental illness;\n* Subject suffers from vertigo, fear of heights or brain trauma;\n* The subject has photophobia and tears caused by keratitis, conjunctivitis, internal trichiasis and other diseases at any time;\n* The subject has strabismus or congenital cataract, congenital ptosis, trauma and other ocular organic lesions and related surgical history;\n* Subject has had any form of treatment for amblyopia other than refractive correction and covering treatment.\n* Other conditions, such as severe heart, liver and kidney disease, under which the investigator considers that the patient should not participate in the trial for safety reasons or in the interest of the patient.'}, 'identificationModule': {'nctId': 'NCT05732467', 'briefTitle': 'Effectiveness of Virtual Reality Training in Amblyopia', 'organization': {'class': 'OTHER', 'fullName': 'Second Affiliated Hospital, School of Medicine, Zhejiang University'}, 'officialTitle': 'Effectiveness of Virtual Reality Training in Amblyopia', 'orgStudyIdInfo': {'id': '2022-0755'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'EXPERIMENTAL', 'label': 'experimental group', 'interventionNames': ['Device: visual function training software', 'Other: corrective glasses']}, {'type': 'OTHER', 'label': 'control group', 'interventionNames': ['Other: occlusion therapy', 'Other: corrective glasses']}], 'interventions': [{'name': 'visual function training software', 'type': 'DEVICE', 'otherNames': ['visual function training software (model: SJ-JRS2021)'], 'description': 'Experimental group: If there is a refractive problem, first correct the refraction, wear corrective glasses, and then use visual function training therapy software (model: SJ-JRS2021) for treatment.', 'armGroupLabels': ['experimental group']}, {'name': 'occlusion therapy', 'type': 'OTHER', 'description': 'Control group: If there is a refractive problem, correct the refraction first, wear corrective glasses combined with occlusion therapy, and cover the fellow eye for 2 hours a day.', 'armGroupLabels': ['control group']}, {'name': 'corrective glasses', 'type': 'OTHER', 'description': 'corrective glasses', 'armGroupLabels': ['control group', 'experimental group']}]}, 'contactsLocationsModule': {'locations': [{'city': 'Hangzhou', 'state': 'Zhejiang', 'status': 'RECRUITING', 'country': 'China', 'contacts': [{'name': 'Xiajing Tang', 'role': 'CONTACT', 'email': 'xiajingtang@zju.edu.cn', 'phone': '+86 13732227517'}], 'facility': 'The Second Affiliated Hospital of Zhejiang University School of Medicine', 'geoPoint': {'lat': 30.29365, 'lon': 120.16142}}], 'centralContacts': [{'name': 'Xiajing Tang', 'role': 'CONTACT', 'email': 'xiajingtang@zju.edu.cn', 'phone': '+86 13732227517'}], 'overallOfficials': [{'name': 'Xiajing Tang', 'role': 'STUDY_CHAIR', 'affiliation': 'Second Affiliated Hospital, School of Medicine, Zhejiang University'}]}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Second Affiliated Hospital, School of Medicine, Zhejiang University', 'class': 'OTHER'}, 'responsibleParty': {'type': 'SPONSOR'}}}}