Ignite Creation Date:
2025-12-25 @ 3:48 AM
Ignite Modification Date:
2026-03-04 @ 9:54 PM
Study NCT ID:
NCT03735602
Status:
UNKNOWN
Last Update Posted:
2020-05-19
First Post:
2018-10-24
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Neural Mechanisms Underlying Astigmatism
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'conditionBrowseModule': {'meshes': [{'id': 'D001251', 'term': 'Astigmatism'}], 'ancestors': [{'id': 'D012030', 'term': 'Refractive Errors'}, {'id': 'D005128', 'term': 'Eye Diseases'}]}}, 'protocolSection': {'designModule': {'phases': ['NA'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'NA', 'maskingInfo': {'masking': 'NONE'}, 'primaryPurpose': 'BASIC_SCIENCE', 'interventionModel': 'SINGLE_GROUP'}, 'enrollmentInfo': {'type': 'ESTIMATED', 'count': 20}}, 'statusModule': {'overallStatus': 'UNKNOWN', 'lastKnownStatus': 'RECRUITING', 'startDateStruct': {'date': '2019-07-01', 'type': 'ACTUAL'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2020-05', 'completionDateStruct': {'date': '2021-12', 'type': 'ESTIMATED'}, 'lastUpdateSubmitDate': '2020-05-16', 'studyFirstSubmitDate': '2018-10-24', 'studyFirstSubmitQcDate': '2018-11-07', 'lastUpdatePostDateStruct': {'date': '2020-05-19', 'type': 'ACTUAL'}, 'studyFirstPostDateStruct': {'date': '2018-11-08', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2021-03', 'type': 'ESTIMATED'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'The change of the contrast sensitivity function tested by quick CSF', 'timeFrame': 'eight months', 'description': 'The quick CSF (contrast sensitivity function) measures contrast threshold by fitting raw data and calculating the Cutoff sensitivity frequency.'}, {'measure': 'The change of contrast threshold tested by sweep visually evoked potential (VEP)', 'timeFrame': 'eight months', 'description': 'The contrast threshold was calculated by analyzing EEG(Electroencephalogram) data recorded with sweep visually evoked potential (VEP) paradigm.'}]}, 'oversightModule': {'isFdaRegulatedDrug': False, 'isFdaRegulatedDevice': False}, 'conditionsModule': {'conditions': ['Astigmatism']}, 'descriptionModule': {'briefSummary': 'This study is to compare the contrast sensitivity function and neural response to gratings before and after the orientation discrimination task in the astigmatism or amblyopia patients.', 'detailedDescription': 'The presence of astigmatism can lead to substantial reductions in visual performance in a variety of clinical vision measures and functional visual tasks. However, the neural mechanisms underlying the astigmatism remains unknown. The current study recruited three groups (patients with with-the-rule astigmatism and amblyopia, patients with with-the-rule astigmatism but without amblyopia, normal controls) of subjects and patients receive perceptual learning training (orientation discrimination task) which lasts for around 15 days. This main aim is to compare the contrast sensitivity function and neural response to gratings before and after the orientation discrimination task in the astigmatism or amblyopia patients.\n\nPatients with astigmatism or amblyopia were included in this study. All participants underwent an ophthalmic examination that included slit-lamp biomicroscopy, visual acuity, quick CSF under full optical correction, 9-SF life quality questionnaire and fundus examination.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['CHILD'], 'maximumAge': '16 Years', 'minimumAge': '10 Years', 'healthyVolunteers': True, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* high astigmatism\n\nExclusion Criteria:\n\n* other types of disease (especially optical diseases) that may affect study'}, 'identificationModule': {'nctId': 'NCT03735602', 'briefTitle': 'Neural Mechanisms Underlying Astigmatism', 'organization': {'class': 'OTHER', 'fullName': 'Zhongshan Ophthalmic Center, Sun Yat-sen University'}, 'officialTitle': 'The Research of the Neural Mechanisms Underlying Astigmatism', 'orgStudyIdInfo': {'id': 'JYuan'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'EXPERIMENTAL', 'label': 'perceptual training', 'description': 'Orientation discrimination task, which is a cognitive task. Patients were trained for 1 hour per day, 15 days in total.', 'interventionNames': ['Behavioral: perceptual training']}], 'interventions': [{'name': 'perceptual training', 'type': 'BEHAVIORAL', 'description': 'orientation discrimination task', 'armGroupLabels': ['perceptual training']}]}, 'contactsLocationsModule': {'locations': [{'zip': '510000', 'city': 'Guangzhou', 'state': 'Guangdong', 'status': 'RECRUITING', 'country': 'China', 'contacts': [{'name': 'Li Gu, Dr.', 'role': 'CONTACT', 'email': 'guli7@mail2.sysu.edu.cn', 'phone': '15889937313', 'phoneExt': '+86'}, {'name': 'Jin yuan, Prof.', 'role': 'PRINCIPAL_INVESTIGATOR'}], 'facility': 'Zhongshan Ophthalmic Center', 'geoPoint': {'lat': 23.11667, 'lon': 113.25}}], 'centralContacts': [{'name': 'Li Gu, Phd', 'role': 'CONTACT', 'email': 'guli7@mail2.sysu.edu.cn', 'phone': '15889937313', 'phoneExt': '+86'}, {'name': 'Jin Yuan, Professor', 'role': 'CONTACT', 'email': 'yuanjincornea@126.com', 'phone': '2087333391'}], 'overallOfficials': [{'name': 'Jin Yuan, Professor', 'role': 'STUDY_CHAIR', 'affiliation': 'Zhongshan Ophthalmic Center, Sun Yat-sen University'}]}, 'ipdSharingStatementModule': {'ipdSharing': 'UNDECIDED'}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Zhongshan Ophthalmic Center, Sun Yat-sen University', 'class': 'OTHER'}, 'responsibleParty': {'type': 'PRINCIPAL_INVESTIGATOR', 'investigatorTitle': 'Clinical Professor', 'investigatorFullName': 'Jin Yuan', 'investigatorAffiliation': 'Zhongshan Ophthalmic Center, Sun Yat-sen University'}}}}