Ignite Creation Date:
2025-12-25 @ 4:17 AM
Ignite Modification Date:
2025-12-26 @ 3:17 AM
Study NCT ID:
NCT06184620
Status:
COMPLETED
Last Update Posted:
2023-12-28
First Post:
2023-12-14
Is NOT Gene Therapy:
False
Has Adverse Events:
False
Brief Title:
Correlation Between Angle Closure Glaucoma Data and Lens Zonule Status
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'conditionBrowseModule': {'meshes': [{'id': 'D015812', 'term': 'Glaucoma, Angle-Closure'}], 'ancestors': [{'id': 'D005901', 'term': 'Glaucoma'}, {'id': 'D009798', 'term': 'Ocular Hypertension'}, {'id': 'D005128', 'term': 'Eye Diseases'}]}}, 'protocolSection': {'designModule': {'studyType': 'OBSERVATIONAL', 'designInfo': {'timePerspective': 'RETROSPECTIVE', 'observationalModel': 'OTHER'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 263}, 'patientRegistry': False}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '2020-12-01', 'type': 'ACTUAL'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2023-12', 'completionDateStruct': {'date': '2023-03-30', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2023-12-14', 'studyFirstSubmitDate': '2023-12-14', 'studyFirstSubmitQcDate': '2023-12-14', 'lastUpdatePostDateStruct': {'date': '2023-12-28', 'type': 'ACTUAL'}, 'studyFirstPostDateStruct': {'date': '2023-12-28', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2023-03-30', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Axial Length (AL), Lens Thickness (LT),Lens Vault (LV), Pupil Diameter (PD),', 'timeFrame': 'before operation', 'description': 'Axial Length (AL), Lens Thickness (LT),Lens Vault (LV), Pupil Diameter (PD),'}, {'measure': 'Anterior Chamber Depth (ACD) in seat and rectum position, White To White (WTW), pupil vault (LV), pupil diameter (PD), The Lens Zonular Length (LZL) and Angle Opening Distance at 500μm (AOD500) in the upper, lower, nasal and temporal directions', 'timeFrame': 'before operation', 'description': 'Anterior Chamber Depth (ACD) in seat and rectum position, White To White (WTW), pupil vault (LV), pupil diameter (PD), The Lens Zonular Length (LZL) and Angle Opening Distance at 500μm (AOD500) in the upper, lower, nasal and temporal directions'}]}, 'oversightModule': {'oversightHasDmc': False, 'isFdaRegulatedDrug': False, 'isFdaRegulatedDevice': False}, 'conditionsModule': {'keywords': ['primary angle closure glaucoma', 'UBM', 'lens zonule'], 'conditions': ['Primary Angle Closure Glaucoma']}, 'descriptionModule': {'briefSummary': 'The goal of this observational study is to discuss the correlation between primary angle-closure glaucoma and the state of the suspended ligament of the lens and the pathogenesis of PACG by measuring the biological data of primary angle-closure glaucoma and observing its anatomical changes.', 'detailedDescription': 'Patients clinically diagnosed with Primary angle-closure glaucoma (PACG) and normal control patients from December 2020 to January 2022 were enrolled in this study.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'maximumAge': '91 Years', 'minimumAge': '47 Years', 'samplingMethod': 'NON_PROBABILITY_SAMPLE', 'studyPopulation': 'From December 2020 to January 2022, patients with primary angle-closure glaucoma and normal control patients were diagnosed for the first time and intended to undergo cataract surgery in the ophthalmology department of the First Affiliated Hospital of Shandong First Medical University (Shandong Qiandfo Hospital).', 'healthyVolunteers': True, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* The depth of the anterior chamber is normal, and the whole corner of the chamber is open;\n* The cup-to-plate ratio is less than 0.5;\n* No family history of glaucoma.\n\nExclusion Criteria:\n\n* Previous history of trauma or internal eye surgery in both eyes or one eye;\n* Used "pilocarpine", "atropine" and other drugs to change the size of the pupil and the shape of the chamber Angle within 1 week;\n* Combined with other eye diseases affecting the Angle and suspension ligament, such as uveitis, ciliary cyst, high myopia, retinal diseases, etc.;\n* Can not cooperate with UBM and Angle scopy;\n* Refuse to participate in this researcher.'}, 'identificationModule': {'nctId': 'NCT06184620', 'briefTitle': 'Correlation Between Angle Closure Glaucoma Data and Lens Zonule Status', 'organization': {'class': 'OTHER', 'fullName': 'Qianfoshan Hospital'}, 'officialTitle': 'Correlation Between Angle Closure Glaucoma Data and Lens Zonule Status', 'orgStudyIdInfo': {'id': 'YXLL-KY-2023(047)'}}, 'armsInterventionsModule': {'armGroups': [{'label': 'PACG group', 'description': 'All patients in the experimental group met the diagnostic criteria of primary angle-closure glaucoma in the Chinese Glaucoma Guidelines(2020).'}, {'label': 'control group', 'description': 'The depth of the anterior chamber is normal, and the whole corner of the chamber is open; The cup-to-plate ratio is less than 0.5; No family history of glaucoma'}]}, 'contactsLocationsModule': {'locations': [{'zip': '250000', 'city': 'Jinan', 'state': 'Shandong', 'country': 'China', 'facility': 'guangfu Dang', 'geoPoint': {'lat': 36.66833, 'lon': 116.99722}}]}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Guangfu Dang', 'class': 'OTHER'}, 'responsibleParty': {'type': 'SPONSOR_INVESTIGATOR', 'investigatorTitle': 'professor', 'investigatorFullName': 'Guangfu Dang', 'investigatorAffiliation': 'Qianfoshan Hospital'}}}}