Ignite Creation Date:
2025-12-24 @ 7:32 PM
Ignite Modification Date:
2026-06-13 @ 8:15 PM
Study NCT ID:
NCT04263103
Status:
UNKNOWN
Last Update Posted:
2020-02-10
First Post:
2020-02-06
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
A Training Software (SJ-RS-WL2015) Rehabilitating Intermittent Exotropia Binocular Functions
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}}, 'protocolSection': {'designModule': {'phases': ['NA'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'RANDOMIZED', 'maskingInfo': {'masking': 'TRIPLE', 'whoMasked': ['CARE_PROVIDER', 'INVESTIGATOR', 'OUTCOMES_ASSESSOR']}, 'primaryPurpose': 'TREATMENT', 'interventionModel': 'PARALLEL'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 92}}, 'statusModule': {'overallStatus': 'UNKNOWN', 'lastKnownStatus': 'ACTIVE_NOT_RECRUITING', 'startDateStruct': {'date': '2019-12-09', 'type': 'ACTUAL'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2020-02', 'completionDateStruct': {'date': '2020-12-31', 'type': 'ESTIMATED'}, 'lastUpdateSubmitDate': '2020-02-07', 'studyFirstSubmitDate': '2020-02-06', 'studyFirstSubmitQcDate': '2020-02-07', 'lastUpdatePostDateStruct': {'date': '2020-02-10', 'type': 'ACTUAL'}, 'studyFirstPostDateStruct': {'date': '2020-02-10', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2020-10-31', 'type': 'ESTIMATED'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Change from Baseline Stereopsis at 12 months', 'timeFrame': '12 months', 'description': 'Measured with Synoptophore and Titmus stereo test, respectively'}, {'measure': 'Change from Baseline Fusion at 12 months', 'timeFrame': '12 months', 'description': 'Measured with Worth 4-dot test and Synoptophore, respectively'}, {'measure': 'Change from Baseline Simultaneous Perception at 12 months', 'timeFrame': '12 months', 'description': 'Measured with Bagolini striated lens, Worth 4-dot test, and Synoptophore, respectively'}, {'measure': 'Change from Baseline Stereopsis at 6 months', 'timeFrame': '6 months', 'description': 'Measured with Synoptophore and Titmus stereo test, respectively'}, {'measure': 'Change from Baseline Fusion at 6 months', 'timeFrame': '6 months', 'description': 'Measured with Worth 4-dot test and Synoptophore, respectively'}, {'measure': 'Change from Baseline Simultaneous Perception at 6 months', 'timeFrame': '6 months', 'description': 'Measured with Bagolini striated lens, Worth 4-dot test, and Synoptophore, respectively'}, {'measure': 'Change from Baseline Stereopsis at 3 months', 'timeFrame': '3 months', 'description': 'Measured with Synoptophore and Titmus stereo test, respectively'}, {'measure': 'Change from Baseline Fusion at 3 months', 'timeFrame': '3 months', 'description': 'Measured with Worth 4-dot test and Synoptophore, respectively'}, {'measure': 'Change from Baseline Simultaneous Perception at 3 months', 'timeFrame': '3 months', 'description': 'Measured with Bagolini striated lens, Worth 4-dot test, and Synoptophore, respectively'}, {'measure': 'Change from Baseline Stereopsis at 2 months', 'timeFrame': '2 months', 'description': 'Measured with Synoptophore and Titmus stereo test, respectively'}, {'measure': 'Change from Baseline Fusion at 2 months', 'timeFrame': '2 months', 'description': 'Measured with Worth 4-dot test and Synoptophore, respectively'}, {'measure': 'Change from Baseline Simultaneous Perception at 2 months', 'timeFrame': '2 months', 'description': 'Measured with Bagolini striated lens, Worth 4-dot test, and Synoptophore, respectively'}, {'measure': 'Change from Baseline Stereopsis at 1 month', 'timeFrame': '1 month', 'description': 'Measured with Synoptophore and Titmus stereo test, respectively'}, {'measure': 'Change from Baseline Fusion at 1 month', 'timeFrame': '1 month', 'description': 'Measured with Worth 4-dot test and Synoptophore, respectively'}, {'measure': 'Change from Baseline Simultaneous Perception at 1 month', 'timeFrame': '1 month', 'description': 'Measured with Bagolini striated lens, Worth 4-dot test, and Synoptophore,'}], 'secondaryOutcomes': [{'measure': 'Visual Acuity', 'timeFrame': 'one year', 'description': 'by LogMAR Visual Acuity Chart'}, {'measure': 'Change from Baseline Deviation Degree at 1 year', 'timeFrame': '1 year', 'description': 'by Prism Test'}, {'measure': 'Change from Baseline Refractive Error at 1 year', 'timeFrame': '1 year', 'description': 'by Phoropter'}]}, 'oversightModule': {'oversightHasDmc': True, 'isFdaRegulatedDrug': False, 'isFdaRegulatedDevice': False}, 'conditionsModule': {'keywords': ['Intermittent Exotropia'], 'conditions': ['Intermittent Exotropia']}, 'descriptionModule': {'briefSummary': 'Evaluating the effect of SJ-RS-WL2015 visual training program in children with intermittent exotropia after eye surgery, including the improvement of simultaneous perception (I binocular function), fusion (II binocular function), stereopsis (III binocular function).', 'detailedDescription': 'All the patients are after eye surgery for intermittent exotropia. All the participants with 20/20 or better visual acuity.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['CHILD'], 'maximumAge': '16 Years', 'minimumAge': '5 Years', 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* Clinical diagnosis of Intermittent Exotropia\n* Must be after eye surgery for Intermittent Exotropia\n* Baseline Deviation Range: Esotropia\\<=5△ or Exotropia\\<15△ after Eye Surgery\n* Visual Acuity: \\>=20/20\n\nExclusion Criteria:\n\n* A-V patterns deviations\n* Abnormal oblique or vertical rectus\n* Nystagmus\n* Ophthalmoplegia\n* Anisometropia \\>2.5D\n* With other eye surgery history\n* Mental disorder\n* Neural disease\n* Tumor\n* Heart disease\n* Hypertension\n* Epilepsy\n* Severe systemic disease\n* With vision therapy history within 4 weeks\n* Implanted electronic device\n* In other researches within 4 weeks'}, 'identificationModule': {'nctId': 'NCT04263103', 'briefTitle': 'A Training Software (SJ-RS-WL2015) Rehabilitating Intermittent Exotropia Binocular Functions', 'organization': {'class': 'INDUSTRY', 'fullName': 'Guangzhou Shijing Medical Software'}, 'officialTitle': 'A Phase 4 Randomized, Single-blind Study to Evaluate the Multi-media Training（SJ-RS-WL2015）Software Rehabilitating Ability of Binocular Functions in Hospitalized Adolescent Patients With Intermittent Exotropia After Eye Surgery', 'orgStudyIdInfo': {'id': 'GuangzhouShijingMS2020ITE'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'EXPERIMENTAL', 'label': 'Experimental group with SJ-RS-WL2015', 'description': 'Item code: SJ-RS-WL2015, a visual training software program, 15 minutes of one section, twice a day, and for 1 year', 'interventionNames': ['Other: SJ-RS-WL2015 visual training program software']}, {'type': 'NO_INTERVENTION', 'label': 'control group', 'description': 'No special treatment, but observation'}], 'interventions': [{'name': 'SJ-RS-WL2015 visual training program software', 'type': 'OTHER', 'otherNames': ['SJ-RS-WL2015 visual training program'], 'description': 'It is a software with perceptual learning methods for binocular functions', 'armGroupLabels': ['Experimental group with SJ-RS-WL2015']}]}, 'contactsLocationsModule': {'locations': [{'zip': '510000', 'city': 'Guangzhou', 'state': 'Guangdong', 'country': 'China', 'facility': 'Guangzhou Shijing Medical Software Co., Ltd.', 'geoPoint': {'lat': 23.11667, 'lon': 113.25}}, {'zip': '510000', 'city': 'Guanzhou', 'state': 'Guangdong', 'country': 'China', 'facility': 'Zhongshan Ophthalmic center, Sun Yat-sen University', 'geoPoint': {'lat': 23.06828, 'lon': 113.37117}}]}, 'ipdSharingStatementModule': {'ipdSharing': 'NO'}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Guangzhou Shijing Medical Software', 'class': 'INDUSTRY'}, 'collaborators': [{'name': 'Zhongshan Ophthalmic Center, Sun Yat-sen University', 'class': 'OTHER'}], 'responsibleParty': {'type': 'SPONSOR'}}}}