Ignite Creation Date:
2025-12-24 @ 5:57 PM
Ignite Modification Date:
2025-12-29 @ 5:44 AM
Study NCT ID:
NCT04499768
Status:
UNKNOWN
Last Update Posted:
2020-08-05
First Post:
2020-07-30
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
A Longitudinal Study of Choroidal Changes After Cataract Surgery in Eyes With Diabetic Retinopathy
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'conditionBrowseModule': {'meshes': [{'id': 'D003930', 'term': 'Diabetic Retinopathy'}], 'ancestors': [{'id': 'D012164', 'term': 'Retinal Diseases'}, {'id': 'D005128', 'term': 'Eye Diseases'}, {'id': 'D003925', 'term': 'Diabetic Angiopathies'}, {'id': 'D014652', 'term': 'Vascular Diseases'}, {'id': 'D002318', 'term': 'Cardiovascular Diseases'}, {'id': 'D048909', 'term': 'Diabetes Complications'}, {'id': 'D003920', 'term': 'Diabetes Mellitus'}, {'id': 'D004700', 'term': 'Endocrine System Diseases'}]}}, 'protocolSection': {'designModule': {'studyType': 'OBSERVATIONAL', 'designInfo': {'timePerspective': 'PROSPECTIVE', 'observationalModel': 'CASE_CONTROL'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 46}, 'patientRegistry': False}, 'statusModule': {'overallStatus': 'UNKNOWN', 'lastKnownStatus': 'ENROLLING_BY_INVITATION', 'startDateStruct': {'date': '2018-06-01', 'type': 'ACTUAL'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2020-08', 'completionDateStruct': {'date': '2020-12-30', 'type': 'ESTIMATED'}, 'lastUpdateSubmitDate': '2020-08-04', 'studyFirstSubmitDate': '2020-07-30', 'studyFirstSubmitQcDate': '2020-08-04', 'lastUpdatePostDateStruct': {'date': '2020-08-05', 'type': 'ACTUAL'}, 'studyFirstPostDateStruct': {'date': '2020-08-05', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2019-10-30', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'CVI at baseline', 'timeFrame': 'CVI was assessed at baseline(within 1 week before surgery)', 'description': 'choroidal vascularity index(CVI) was defined as the proportion of vascular area to total circumscribed area.'}, {'measure': 'CVI at 1 week postoperatively', 'timeFrame': 'CVI was assessed 1 week after surgery.', 'description': 'choroidal vascularity index (CVI) was defined as the proportion of vascular area to total circumscribed area.'}, {'measure': 'CVI at 1 month postoperatively', 'timeFrame': 'CVI was assessed 1 month after surgery.', 'description': 'choroidal vascularity index (CVI) was defined as the proportion of vascular area to total circumscribed area.'}, {'measure': 'CVI at 3 months postoperatively', 'timeFrame': 'CVI was assessed 3 months after surgery.', 'description': 'choroidal vascularity index (CVI)was defined as the proportion of vascular area to total circumscribed area.'}, {'measure': 'CT at baseline', 'timeFrame': 'CT was assessed at baseline and 1 week, 1 month, 3 month after surgery.', 'description': 'Choroid thickness (CT) was the thickness of the choroidal layer; CT values were obtained with the built-in software of the SS-OCT device.'}, {'measure': 'CT at 1 week postoperatively', 'timeFrame': 'CT was assessed at 1 week after surgery.', 'description': 'Choroid thickness (CT) was the thickness of the choroidal layer; CT values were obtained with the built-in software of the SS-OCT device.'}, {'measure': 'CT at 1 month postoperatively', 'timeFrame': 'CT was assessed at 1 month after surgery.', 'description': 'Choroid thickness (CT) was the thickness of the choroidal layer; CT values were obtained with the built-in software of the SS-OCT device.'}, {'measure': 'CT at 3 months postoperatively', 'timeFrame': 'CT was assessed at 3 months after surgery.', 'description': 'Choroid thickness (CT) was the thickness of the choroidal layer, CT values were obtained with the built-in software of the SS-OCT device.'}, {'measure': 'VD at baseline', 'timeFrame': 'VD of the choriocapillaris was assessed at baseline.', 'description': 'VD of the choriocapillaris was the vessel density of the choriocapillaris in the choroid.'}, {'measure': 'VD at 1 week postoperatively', 'timeFrame': 'VD of the choriocapillaris was assessed 1 week after surgery.', 'description': 'VD of the choriocapillaris was the vessel density of the choriocapillaris in the choroid.'}, {'measure': 'VD at 1 month postoperatively', 'timeFrame': 'VD of the choriocapillaris was assessed 1 month after surgery.', 'description': 'VD of the choriocapillaris was the vessel density of the choriocapillaris in the choroid.'}, {'measure': 'VD at 3 months postoperatively', 'timeFrame': 'VD of the choriocapillaris was assessed 3 months after surgery.', 'description': 'VD of the choriocapillaris was the vessel density of the choriocapillaris in the choroid'}], 'secondaryOutcomes': [{'measure': 'IOP at baseline', 'timeFrame': 'IOP was assessed at baseline and 1 week, 1 month, 3 month after surgery.', 'description': 'IOP was the value of intraocular pressure.'}, {'measure': 'IOP at 1 week postoperatively', 'timeFrame': 'IOP was assessed 1 week after surgery.', 'description': 'IOP was the value of intraocular pressure .'}, {'measure': 'IOP at 1 month postoperatively', 'timeFrame': 'IOP was assessed 1 month after surgery.', 'description': 'IOP was the value of intraocular pressure.'}, {'measure': 'IOP at 3 months postoperatively', 'timeFrame': 'IOP was assessed 3 months after surgery.', 'description': 'IOP was the value of intraocular pressure .'}, {'measure': 'BCVA at baseline', 'timeFrame': 'BCVA was assessed at baseline .', 'description': 'BCVA was the best corrected visual acuity.'}, {'measure': 'BCVA at 3 months postoperatively', 'timeFrame': 'BCVA was assessed 3 months after surgery.', 'description': 'BCVA was the best corrected visual acuity.'}]}, 'oversightModule': {'isFdaRegulatedDrug': False, 'isFdaRegulatedDevice': False}, 'conditionsModule': {'keywords': ['Diabetic choroidopathy', 'Diabetic retinopathy', 'choroidal vascularity index', 'choroidal thickness'], 'conditions': ['Optical Coherence Tomography', 'Diabetic Retinopathy', 'Choroid']}, 'referencesModule': {'references': [{'pmid': '33178452', 'type': 'DERIVED', 'citation': 'Yao H, Gao S, Liu X, Zhou Y, Cheng Y, Shen X. Choroidal Structural Changes Assessed with Swept-Source Optical Coherence Tomography after Cataract Surgery in Eyes with Diabetic Retinopathy. J Ophthalmol. 2020 Oct 29;2020:5839837. doi: 10.1155/2020/5839837. eCollection 2020.'}]}, 'descriptionModule': {'briefSummary': 'To determine the influence of phacoemulsification on choroidal vasculature in patients with diabetic retinopathy (DR) undergoing cataract surgery', 'detailedDescription': 'To determine the influence of phacoemulsification on choroidal vasculature in patients with diabetic retinopathy (DR) undergoing cataract surgery through the follow-up of choroidal thickness (CT) and choroidal vascularity index (CVI) using swept-source optical coherence tomography (SS-OCT) system.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'maximumAge': '80 Years', 'minimumAge': '40 Years', 'samplingMethod': 'NON_PROBABILITY_SAMPLE', 'studyPopulation': '23 eyes of 23 cataract patients with mild/moderate NPDR without DME, and 23 age-matched non-diabetic patients', 'eligibilityCriteria': 'Inclusion Criteria:\n\n* agedā©¾40years; intraocular pressure (IOP) \\< 21 mm Hg in both eyes, spherical refractive error\\<6 diopters spherical equivalent.\n\nExclusion Criteria:\n\n* previous retinal surgery, glaucoma, uveitis, age-related macular degeneration, arterial or vein occlusions, macular hole, or other ocular diseases that could interfere the CT and/or CVI measurement, severe systemic diseases, such as uncontrolled hypertension, obstructive sleep apnea, etc.'}, 'identificationModule': {'nctId': 'NCT04499768', 'briefTitle': 'A Longitudinal Study of Choroidal Changes After Cataract Surgery in Eyes With Diabetic Retinopathy', 'organization': {'class': 'OTHER', 'fullName': 'Ruijin Hospital'}, 'officialTitle': 'A Longitudinal Study of Choroidal Changes Assessed With Swept-source Optical Coherence Tomography After Cataract Surgery in Eyes With Diabetic Retinopathy', 'orgStudyIdInfo': {'id': '2018ZY14'}}, 'armsInterventionsModule': {'armGroups': [{'label': 'control', 'description': 'the age-related cataract patients'}, {'label': 'DR group', 'description': 'the cataract patients with mild/moderate NPDR'}]}, 'contactsLocationsModule': {'locations': [{'zip': '200025', 'city': 'Shanghai', 'state': 'Shanghai Municipality', 'country': 'China', 'facility': 'Ruijin Hospital', 'geoPoint': {'lat': 31.22222, 'lon': 121.45806}}], 'overallOfficials': [{'name': 'Xi Shen, PhD', 'role': 'STUDY_DIRECTOR', 'affiliation': 'Shanghai Jiao Tong University School of Medicine'}]}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Ruijin Hospital', 'class': 'OTHER'}, 'responsibleParty': {'type': 'PRINCIPAL_INVESTIGATOR', 'investigatorTitle': 'chief physician', 'investigatorFullName': 'Xi Shen', 'investigatorAffiliation': 'Ruijin Hospital'}}}}