Ignite Creation Date:
2025-12-24 @ 11:25 PM
Ignite Modification Date:
2026-02-21 @ 3:12 PM
Study NCT ID:
NCT06687356
Status:
RECRUITING
Last Update Posted:
2025-05-22
First Post:
2024-11-08
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Study on the Application of Intraoperative Optical Coherence Tomography Technique in the Diagnosis and Treatment of Lens Diseases
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'conditionBrowseModule': {'meshes': [{'id': 'D007905', 'term': 'Lens Diseases'}], 'ancestors': [{'id': 'D005128', 'term': 'Eye Diseases'}]}, 'interventionBrowseModule': {'meshes': [{'id': 'D013514', 'term': 'Surgical Procedures, Operative'}]}}, 'protocolSection': {'designModule': {'phases': ['NA'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'RANDOMIZED', 'maskingInfo': {'masking': 'SINGLE', 'whoMasked': ['PARTICIPANT']}, 'primaryPurpose': 'TREATMENT', 'interventionModel': 'SINGLE_GROUP'}, 'enrollmentInfo': {'type': 'ESTIMATED', 'count': 600}}, 'statusModule': {'overallStatus': 'RECRUITING', 'startDateStruct': {'date': '2024-11-27', 'type': 'ACTUAL'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2025-05', 'completionDateStruct': {'date': '2029-12-31', 'type': 'ESTIMATED'}, 'lastUpdateSubmitDate': '2025-05-20', 'studyFirstSubmitDate': '2024-11-08', 'studyFirstSubmitQcDate': '2024-11-12', 'lastUpdatePostDateStruct': {'date': '2025-05-22', 'type': 'ACTUAL'}, 'studyFirstPostDateStruct': {'date': '2024-11-13', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2029-12-31', 'type': 'ESTIMATED'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Successful implantation rate of intraocular lens', 'timeFrame': 'through study completion, an average of 1 year', 'description': 'Implantation rate of intraocular lens after surgery.'}, {'measure': 'Intraocular lens position after implantation', 'timeFrame': '1day, 1 week and 1 month postoperation', 'description': 'The location of intraocular lens after surgery, observed through slit - lamp and anterior segment optical coherence tomography.'}], 'secondaryOutcomes': [{'measure': 'Postoperative corneal incision closure status', 'timeFrame': '1day, 1 week postoperation', 'description': 'Corneal incision closure status after surgery, observed through slit - lamp and anterior segment optical coherence tomography.'}, {'measure': 'Visual function', 'timeFrame': '1day, 1 week, 1 month, 3month postoperation', 'description': 'Best corrected visual acuity (BCVA) measured using a decimal chart Best corrected visual acuity (BCVA) measured using a decimal chart'}]}, 'oversightModule': {'isUsExport': False, 'oversightHasDmc': False, 'isFdaRegulatedDrug': False, 'isFdaRegulatedDevice': False}, 'conditionsModule': {'conditions': ['Lens Diseases']}, 'descriptionModule': {'briefSummary': 'Accurately assessing and dealing with anterior segment changes in the eyes of patients with lens diseases can better guide the operation details during surgery and make reasonable plans for possible intraoperative and postoperative complications. Applying the intraoperative optical coherence tomography technique, this study analyzes the correlation between preoperative, intraoperative anterior segment structural changes and postoperative surgical effects in patients with lens diseases, and evaluates the clinical benefits of intraoperative optical coherence tomography technique in lens surgery. This study is intended to further improve the diagnosis and treatment quality of clinical lens diseases.', 'detailedDescription': 'In the eyes of patients with lens diseases, there are often some special anterior segment changes, including ectopia lentis, abnormal lens morphology, and rupture of the lens capsule. These changes can be caused by ocular trauma, congenital anomalies, or be secondary to other ocular diseases and systemic diseases. Accurately assessing and dealing with these anterior segment changes can better guide the operation details during surgery and make reasonable plans for possible intraoperative and postoperative complications. This study is based on intraoperative optical coherence tomography technique, analyzes the correlation between preoperative, intraoperative anterior segment structural changes and postoperative surgical effects in patients with lens diseases, and evaluates the clinical benefits of intraoperative optical coherence tomography technique in lens surgery. This study is intended to further improve the diagnosis and treatment quality of clinical lens diseases.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'minimumAge': '18 Years', 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* Patients aged over 18 years old, with lens opacity or abnormal position, and other conditions meeting the surgical indications, needing lens surgery treatment, with or without anterior segment structural changes.\n\nExclusion Criteria:\n\n* Combined with other eye diseases that seriously affect visual prognosis, serious systemic diseases and other conventional contraindications for lens surgery.'}, 'identificationModule': {'nctId': 'NCT06687356', 'briefTitle': 'Study on the Application of Intraoperative Optical Coherence Tomography Technique in the Diagnosis and Treatment of Lens Diseases', 'organization': {'class': 'OTHER', 'fullName': 'Second Affiliated Hospital, School of Medicine, Zhejiang University'}, 'officialTitle': 'Study on the Application of Intraoperative Optical Coherence Tomography Technique in the Diagnosis and Treatment of Lens Diseases', 'orgStudyIdInfo': {'id': '2024-0993'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'ACTIVE_COMPARATOR', 'label': 'Traditional surgery', 'description': 'Without using the intraoperative optical coherence tomography technique during surgery.', 'interventionNames': ['Procedure: Conventional surgery']}, {'type': 'EXPERIMENTAL', 'label': 'Surgery with intraoperative optical coherence tomography technique', 'description': 'Applying the intraoperative optical coherence tomography technique during surgery.', 'interventionNames': ['Procedure: Surgery with Intraoperative Optical Coherence Tomography application']}], 'interventions': [{'name': 'Surgery with Intraoperative Optical Coherence Tomography application', 'type': 'PROCEDURE', 'otherNames': ['Surgery with Intraoperative OCT application'], 'description': 'Surgery with the application of intraoperative optical coherence tomography technique. Intraoperative optical coherence tomography technique can provide intraocular images and show changes in intraocular structures, assisting in analyzing the correlation between preoperative, intraoperative anterior segment structural changes and postoperative surgical effects in patients with lens diseases.', 'armGroupLabels': ['Surgery with intraoperative optical coherence tomography technique']}, {'name': 'Conventional surgery', 'type': 'PROCEDURE', 'description': 'Conventional lens surgery, without the application of intraoperative optical coherence tomography technique.', 'armGroupLabels': ['Traditional surgery']}]}, 'contactsLocationsModule': {'locations': [{'zip': '310009', 'city': 'Hangzhou', 'state': 'Zhejiang', 'status': 'NOT_YET_RECRUITING', 'country': 'China', 'contacts': [{'name': 'Wen Xu', 'role': 'CONTACT', 'email': 'xuwen2003@zju.edu.cn', 'phone': '13858185223'}], 'facility': 'Second Affiliated Hospital, Zhejiang University School of Medicine', 'geoPoint': {'lat': 30.29365, 'lon': 120.16142}}, {'zip': '310009', 'city': 'Hangzhou', 'state': 'Zhejiang', 'status': 'RECRUITING', 'country': 'China', 'contacts': [{'name': 'wen xu', 'role': 'CONTACT', 'email': 'xuwen2003@zju.edu.cn', 'phone': '13858185223'}], 'facility': 'Second Affiliated Hospital, Zhejiang University School of Medicine', 'geoPoint': {'lat': 30.29365, 'lon': 120.16142}}], 'centralContacts': [{'name': 'Wen Xu, PHD', 'role': 'CONTACT', 'email': 'xuwen2003@zju.edu.cn', 'phone': '13858185223'}]}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Second Affiliated Hospital, School of Medicine, Zhejiang University', 'class': 'OTHER'}, 'responsibleParty': {'type': 'SPONSOR'}}}}