Ignite Creation Date:
2025-12-24 @ 8:02 PM
Ignite Modification Date:
2025-12-30 @ 10:58 PM
Study NCT ID:
NCT05220904
Status:
UNKNOWN
Last Update Posted:
2024-08-23
First Post:
2022-01-21
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Perceptual Learning Improve Visual Function in Patients With Keratoconus
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'conditionBrowseModule': {'meshes': [{'id': 'D007640', 'term': 'Keratoconus'}], 'ancestors': [{'id': 'D003316', 'term': 'Corneal Diseases'}, {'id': 'D005128', 'term': 'Eye Diseases'}]}, 'interventionBrowseModule': {'meshes': [{'id': 'D005139', 'term': 'Eyeglasses'}], 'ancestors': [{'id': 'D007909', 'term': 'Lenses'}, {'id': 'D055096', 'term': 'Optical Devices'}, {'id': 'D004864', 'term': 'Equipment and Supplies'}]}}, 'protocolSection': {'designModule': {'phases': ['NA'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'RANDOMIZED', 'maskingInfo': {'masking': 'DOUBLE', 'whoMasked': ['PARTICIPANT', 'CARE_PROVIDER']}, 'primaryPurpose': 'SUPPORTIVE_CARE', 'interventionModel': 'PARALLEL'}, 'enrollmentInfo': {'type': 'ESTIMATED', 'count': 54}}, 'statusModule': {'overallStatus': 'UNKNOWN', 'lastKnownStatus': 'ACTIVE_NOT_RECRUITING', 'startDateStruct': {'date': '2022-02-05', 'type': 'ACTUAL'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2023-11', 'completionDateStruct': {'date': '2024-12-30', 'type': 'ESTIMATED'}, 'lastUpdateSubmitDate': '2024-08-22', 'studyFirstSubmitDate': '2022-01-21', 'studyFirstSubmitQcDate': '2022-01-21', 'lastUpdatePostDateStruct': {'date': '2024-08-23', 'type': 'ACTUAL'}, 'studyFirstPostDateStruct': {'date': '2022-02-02', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2024-12-30', 'type': 'ESTIMATED'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': '3-months corrected visual acuity', 'timeFrame': 'baseline；3 months.', 'description': 'Mean changes of best corrected visual acuity between 3 months after perceptual learning training and baseline values.'}], 'secondaryOutcomes': [{'measure': 'corrected visual acuity of other time frame', 'timeFrame': '6,9,15 months', 'description': 'Mean changes of best corrected visual acuity for 6,9,15 months.'}, {'measure': 'ucorrected visual acuity (UCVA)', 'timeFrame': '3,6,9,15 months', 'description': 'Mean changes of ucorrected visual acuity (UCVA) for 3,6,9,15 months.'}, {'measure': 'contrast sensitivity function (CSF)', 'timeFrame': '3,6,9,15 months', 'description': 'Mean changes of contrast sensitivity function (CSF) for 3,6,9,15 months.'}]}, 'oversightModule': {'isFdaRegulatedDrug': False, 'isFdaRegulatedDevice': False}, 'conditionsModule': {'conditions': ['Keratoconus, Stable']}, 'descriptionModule': {'briefSummary': 'This project aims at non-progressive keratoconus patients with unsatisfactory visual acuity corrected by spectacles, and explores the effectiveness and maintenance of visual acuity improved by perceptual learning.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['CHILD', 'ADULT', 'OLDER_ADULT'], 'minimumAge': '9 Years', 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria:\n\n1. Aged 9 years or older;\n2. Has been diagnosed as Keratoconus,BAD-D≥2.6;\n3. Change of Kmax \\< 1.0 D and change of BAD-D \\<0.4175 betweem the last two Pentacam result;\n4. The best corrected visual acuity of both eyes was between 0.1 and 1.0;\n5. Has voluntarily agreed to participate in the study by signing the statement of informed consent.\n\nExclusion Criteria:\n\n1. Has history of acute keratoconus;\n2. Has other eye diseases or other diseases/conditions causing vision loss;\n3. Has eye surgery history in the past 1year;\n4. Is currently using local/systemic medications or other interventions that may affect visual function;\n5. Receiving other treatments that may affect the results of this study, such as contact lenses during the study;\n6. Has any known neurological diseases;\n7. Participating in other studies currently that may affect the results of this study;\n8. Study other reasons that the physician considers inappropriate for inclusion in the program.'}, 'identificationModule': {'nctId': 'NCT05220904', 'acronym': 'KPL', 'briefTitle': 'Perceptual Learning Improve Visual Function in Patients With Keratoconus', 'organization': {'class': 'OTHER', 'fullName': 'Zhongshan Ophthalmic Center, Sun Yat-sen University'}, 'officialTitle': 'A Randomized Controlled Clinical Study of Perceptual Learning Improving Visual Function in Patients With Keratoconus', 'orgStudyIdInfo': {'id': '2021KYPJ203'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'PLACEBO_COMPARATOR', 'label': 'Placebo Comparator:placebo practice+spectacles', 'description': 'Patients will take placebo practices with spectacles every two days.', 'interventionNames': ['Device: spectacles']}, {'type': 'EXPERIMENTAL', 'label': 'Experimental： perceptual learning practice+spectacles', 'description': 'Patients will take perceptual learning practices with spectacles every two days.', 'interventionNames': ['Device: spectacles', 'Device: perceptual learning']}], 'interventions': [{'name': 'spectacles', 'type': 'DEVICE', 'description': 'Spectacle is the the most common treatment for refractive errors.', 'armGroupLabels': ['Experimental： perceptual learning practice+spectacles', 'Placebo Comparator:placebo practice+spectacles']}, {'name': 'perceptual learning', 'type': 'DEVICE', 'description': "Blurred vision from the eyes can be improved by enhancing the brain's visual processing.", 'armGroupLabels': ['Experimental： perceptual learning practice+spectacles']}]}, 'contactsLocationsModule': {'locations': [{'zip': '510060', 'city': 'Guangzhou', 'state': 'Guangdong', 'country': 'China', 'facility': 'Zhongshan Ophthalmic Center, Sun Yat-sen University', 'geoPoint': {'lat': 23.11667, 'lon': 113.25}}], 'overallOfficials': [{'name': 'Xiao Yang, Professor', 'role': 'STUDY_CHAIR', 'affiliation': 'Zhongshan Ophthalmic Center, Sun Yat-sen University'}]}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Zhongshan Ophthalmic Center, Sun Yat-sen University', 'class': 'OTHER'}, 'responsibleParty': {'type': 'SPONSOR'}}}}