Ignite Creation Date:
2025-12-25 @ 4:29 AM
Ignite Modification Date:
2025-12-26 @ 3:32 AM
Study NCT ID:
NCT07076420
Status:
COMPLETED
Last Update Posted:
2025-07-22
First Post:
2025-07-14
Is NOT Gene Therapy:
False
Has Adverse Events:
False
Brief Title:
Healing of Corneal Incision After Cataract Surgery in Diabetic Patients
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'conditionBrowseModule': {'meshes': [{'id': 'D003920', 'term': 'Diabetes Mellitus'}, {'id': 'D002386', 'term': 'Cataract'}], 'ancestors': [{'id': 'D044882', 'term': 'Glucose Metabolism Disorders'}, {'id': 'D008659', 'term': 'Metabolic Diseases'}, {'id': 'D009750', 'term': 'Nutritional and Metabolic Diseases'}, {'id': 'D004700', 'term': 'Endocrine System Diseases'}, {'id': 'D007905', 'term': 'Lens Diseases'}, {'id': 'D005128', 'term': 'Eye Diseases'}]}}, 'protocolSection': {'designModule': {'studyType': 'OBSERVATIONAL', 'designInfo': {'timePerspective': 'RETROSPECTIVE', 'observationalModel': 'COHORT'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 110}, 'patientRegistry': False}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '2024-04-01', 'type': 'ACTUAL'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2025-07', 'completionDateStruct': {'date': '2025-01-15', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2025-07-14', 'studyFirstSubmitDate': '2025-07-14', 'studyFirstSubmitQcDate': '2025-07-14', 'lastUpdatePostDateStruct': {'date': '2025-07-22', 'type': 'ACTUAL'}, 'studyFirstPostDateStruct': {'date': '2025-07-22', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2024-12-31', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'volume of half cornea with surgical incision', 'timeFrame': 'Before surgery; 1 week after surgery; 1 month after surgery'}, {'measure': 'Defect of corneal incision healing', 'timeFrame': '1 week after surgery; 1 month after surgery', 'description': "Opening of internal orifice; Endothelial dislocation; Descemet's membrane detachment"}]}, 'oversightModule': {'isUsExport': False, 'oversightHasDmc': False, 'isFdaRegulatedDrug': False, 'isFdaRegulatedDevice': False}, 'conditionsModule': {'conditions': ['Diabetes', 'Cataract']}, 'descriptionModule': {'briefSummary': 'The objective of this observational study was to understand the healing of corneal incision after cataract surgery in diabetic patients and its influencing factors. The main questions it aims to answer are:\n\nIs corneal incision healing worse in diabetic patients after cataract surgery than in non-diabetic patients? What are the factors affecting corneal incision healing after cataract surgery in diabetic patients?\n\nThe results of anterior segment optical coherence tomography before and after cataract surgery in cataract patients with or without diabetes will be collected and analyzed.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['CHILD', 'ADULT', 'OLDER_ADULT'], 'samplingMethod': 'NON_PROBABILITY_SAMPLE', 'studyPopulation': 'Patients who were initially diagnosed with cataract and treated with phacoemulsification and intraocular lens implantation at Zhongnan Hospital of Wuhan University from April 1, 2024 to December 31, 2024.', 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria:\n\nPatients who experience blurred vision and painless visual acuity decline, and are diagnosed with cataract (with or without diabetes) through reliable intraocular pressure, visual acuity and slit lamp examinations, and for whom phacoemulsification of cataract can be considered.\n\nExclusion Criteria:\n\n* Use multiple eye drops before surgery.\n* Complicated by other eye diseases that affect corneal healing, such as keratitis, uveitis, glaucoma, etc.\n* Moderate to severe dry eye.\n* History of eye surgery.\n* Moderate to severe dry eye.\n* Grade 5 nuclear cataract.\n* Severe systemic diseases (such as chronic renal failure requiring dialysis, severe neurological diseases, immune diseases), pregnancy or lactation.'}, 'identificationModule': {'nctId': 'NCT07076420', 'briefTitle': 'Healing of Corneal Incision After Cataract Surgery in Diabetic Patients', 'organization': {'class': 'OTHER', 'fullName': 'Zhongnan Hospital'}, 'officialTitle': 'Corneal Incision Healing and Its Influencing Factors After Cataract Phacoemulsification in Diabetic Patients -- Based on Anterior Segment Optical Coherence Tomography', 'orgStudyIdInfo': {'id': '20250122'}}, 'armsInterventionsModule': {'armGroups': [{'label': 'Diabetes group'}, {'label': 'Control group'}]}, 'contactsLocationsModule': {'locations': [{'zip': '430071', 'city': 'Wuhan', 'state': 'Hubei', 'country': 'China', 'facility': 'Zhongnan Hospital of Wuhan University', 'geoPoint': {'lat': 30.58333, 'lon': 114.26667}}]}, 'ipdSharingStatementModule': {'ipdSharing': 'NO'}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Zhongnan Hospital', 'class': 'OTHER'}, 'responsibleParty': {'type': 'SPONSOR'}}}}