Ignite Creation Date:
2026-03-26 @ 3:17 PM
Ignite Modification Date:
2026-03-31 @ 9:22 AM
Study NCT ID:
NCT07336069
Status:
COMPLETED
Last Update Posted:
2026-01-13
First Post:
2026-01-02
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Shilangqing Smart Reading Aid for Improving Reading Ability in Children With Low Vision
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2026-03-25'}}, 'protocolSection': {'designModule': {'phases': ['NA'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'NA', 'maskingInfo': {'masking': 'NONE'}, 'primaryPurpose': 'TREATMENT', 'interventionModel': 'SINGLE_GROUP'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 120}}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '2024-07-01', 'type': 'ACTUAL'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2025-07', 'completionDateStruct': {'date': '2024-09-30', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2026-01-02', 'studyFirstSubmitDate': '2026-01-02', 'studyFirstSubmitQcDate': '2026-01-02', 'lastUpdatePostDateStruct': {'date': '2026-01-13', 'type': 'ACTUAL'}, 'studyFirstPostDateStruct': {'date': '2026-01-13', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2024-08-31', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Asthenopia score', 'timeFrame': '30 min', 'description': 'Participants completed the Visual Fatigue Subjective Scale questionnaire post 30-minute reading session (MEMC and non-MEMC). This 20-item scale assessed eye strain, headaches, perceived clarity, and general comfort, with responses analyzed to identify differences in subjective visual fatigue between conditions.'}], 'secondaryOutcomes': [{'measure': 'Motion sickness score', 'timeFrame': '30 min', 'description': 'Participants completed the Motion sickness Subjective Scale questionnaire post 30-minute reading session.'}, {'measure': 'The first tear film break-up time', 'timeFrame': '30 min', 'description': 'The first tear break-up time of the participants was measured using the ocular Surface Synthesis analyzer after the 30 min reading task'}, {'measure': 'distance eye position', 'timeFrame': '30 min', 'description': 'The distance eye position of the participants was measured using a Maddox rod after the 30-min reading task'}, {'measure': 'near eye position', 'timeFrame': '30 min', 'description': 'The near eye position of the participants was measured using a Maddox rod after the 30-min reading task'}, {'measure': 'AC/A', 'timeFrame': '30 min', 'description': 'AC/A of the participants was measured using Maddox rod after the 30-min reading task'}, {'measure': 'Accommodative responses', 'timeFrame': '30 min', 'description': 'Accommodative responses were measured using a comprehensive refractometer after the 30-min reading task'}, {'measure': 'Intra-ocular pressure', 'timeFrame': '30 min', 'description': 'Intra-ocular pressure were measured using a neural crest tumor after the 30-min reading task'}, {'measure': 'visual acuity', 'timeFrame': '30 min', 'description': 'The visual acuity of the participants were measured using the EDTRS visual acuity chart after the 30-min reading task'}]}, 'oversightModule': {'isFdaRegulatedDrug': False, 'isFdaRegulatedDevice': False}, 'conditionsModule': {'conditions': ['Low Vision Aids']}, 'descriptionModule': {'briefSummary': 'This clinical trial aims to assess the efficacy and safety of the Shilangqing Smart Reading Aid, a head-mounted device integrating XR and AI technologies, in improving reading performance and quality of life among children with low vision. The study employs a multicenter, randomized, controlled design with two parallel groups: an experimental group using the Shilangqing device and a control group using traditional optical magnifiers. Participants will undergo a 12-week intervention period, with primary outcomes focusing on reading speed, accuracy, and user satisfaction. Secondary outcomes include changes in visual acuity, eye health metrics (e.g., tear film stability, visual fatigue), and device-related adverse events. The trial builds on preliminary data from Zhongshan Ophthalmic Center and user feedback indicating high efficacy and safety. An estimated 120 participants aged 6-18 years with best-corrected visual acuity of 0.05 to \\<0.3 will be recruited from multiple sites in China. Results will inform clinical adoption and regulatory approvals for low-vision assistive devices.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT'], 'maximumAge': '60 Years', 'minimumAge': '18 Years', 'healthyVolunteers': True, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* The study included healthy individuals older than 18 years of age with a best-corrected visual acuity (BCVA) of \\<0.1 logarithm of minimum angle of resolution (logMAR) and no ongoing or prior history of ocular or systemic disease.\n\nExclusion Criteria:\n\n* The study excluded healthy individuals younger than 18 years of age with a best-corrected visual acuity (BCVA) of \\>0.1 logarithm of minimum angle of resolution (logMAR) with ongoing or prior history of ocular or systemic disease.'}, 'identificationModule': {'nctId': 'NCT07336069', 'briefTitle': 'Shilangqing Smart Reading Aid for Improving Reading Ability in Children With Low Vision', 'organization': {'class': 'OTHER', 'fullName': 'Zhongshan Ophthalmic Center, Sun Yat-sen University'}, 'officialTitle': 'The Research to Evaluate the Efficacy and Safety of the Shilangqing Smart Reading Aid for Improving Reading Ability in Children With Low Vision (SLQ-001)', 'orgStudyIdInfo': {'id': '2022QXPJ001'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'EXPERIMENTAL', 'label': 'Experimental Group', 'description': 'Using the "Shilangqing" device, conduct reading practice at a brightness level of 400 nit, and measure the eye health indicators before and after the reading session.', 'interventionNames': ['Device: "Langshiqng" visual aid device']}], 'interventions': [{'name': '"Langshiqng" visual aid device', 'type': 'DEVICE', 'description': 'Using the "Langshiqng" visual aid device, conduct reading practice at a brightness level of 400 nit, and measure the eye health indicators before and after the reading session.', 'armGroupLabels': ['Experimental Group']}]}, 'contactsLocationsModule': {'locations': [{'zip': '100730', 'city': 'Beijing', 'country': 'China', 'facility': 'Beijing Ophthalmology and Visual Sciences Key Laboratory, Beijing Tongren Eye Center', 'geoPoint': {'lat': 39.9075, 'lon': 116.39723}}]}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Zhongshan Ophthalmic Center, Sun Yat-sen University', 'class': 'OTHER'}, 'responsibleParty': {'type': 'PRINCIPAL_INVESTIGATOR', 'investigatorTitle': 'PHD', 'investigatorFullName': 'Jin Yuan', 'investigatorAffiliation': 'Beijing Tongren Hospital'}}}}