Ignite Creation Date:
2025-12-24 @ 10:54 PM
Ignite Modification Date:
2025-12-25 @ 8:22 PM
Study NCT ID:
NCT05578469
Status:
UNKNOWN
Last Update Posted:
2022-10-13
First Post:
2022-10-11
Is NOT Gene Therapy:
False
Has Adverse Events:
False
Brief Title:
Surgical Treatment of Marfan Syndrome With Subluxation Lens
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'conditionBrowseModule': {'meshes': [{'id': 'D008382', 'term': 'Marfan Syndrome'}, {'id': 'D007906', 'term': 'Lens Subluxation'}], 'ancestors': [{'id': 'D001848', 'term': 'Bone Diseases, Developmental'}, {'id': 'D001847', 'term': 'Bone Diseases'}, {'id': 'D009140', 'term': 'Musculoskeletal Diseases'}, {'id': 'D006330', 'term': 'Heart Defects, Congenital'}, {'id': 'D018376', 'term': 'Cardiovascular Abnormalities'}, {'id': 'D002318', 'term': 'Cardiovascular Diseases'}, {'id': 'D006331', 'term': 'Heart Diseases'}, {'id': 'D000015', 'term': 'Abnormalities, Multiple'}, {'id': 'D000013', 'term': 'Congenital Abnormalities'}, {'id': 'D009358', 'term': 'Congenital, Hereditary, and Neonatal Diseases and Abnormalities'}, {'id': 'D030342', 'term': 'Genetic Diseases, Inborn'}, {'id': 'D003240', 'term': 'Connective Tissue Diseases'}, {'id': 'D017437', 'term': 'Skin and Connective Tissue Diseases'}, {'id': 'D007905', 'term': 'Lens Diseases'}, {'id': 'D005128', 'term': 'Eye Diseases'}]}}, 'protocolSection': {'designModule': {'studyType': 'OBSERVATIONAL', 'designInfo': {'timePerspective': 'RETROSPECTIVE', 'observationalModel': 'COHORT'}, 'enrollmentInfo': {'type': 'ESTIMATED', 'count': 50}, 'patientRegistry': False}, 'statusModule': {'overallStatus': 'UNKNOWN', 'lastKnownStatus': 'ACTIVE_NOT_RECRUITING', 'startDateStruct': {'date': '2016-01-01', 'type': 'ACTUAL'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2022-09', 'completionDateStruct': {'date': '2024-12-30', 'type': 'ESTIMATED'}, 'lastUpdateSubmitDate': '2022-10-11', 'studyFirstSubmitDate': '2022-10-11', 'studyFirstSubmitQcDate': '2022-10-11', 'lastUpdatePostDateStruct': {'date': '2022-10-13', 'type': 'ACTUAL'}, 'studyFirstPostDateStruct': {'date': '2022-10-13', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2022-11-01', 'type': 'ESTIMATED'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Uncorrected distance visual acuity', 'timeFrame': '1 month postoperatively'}, {'measure': 'Uncorrected distance visual acuity', 'timeFrame': '3 month postoperatively'}, {'measure': 'Corrected distance visual acuity', 'timeFrame': '1 month postoperatively'}, {'measure': 'Corrected distance visual acuity', 'timeFrame': '3 month postoperatively'}, {'measure': 'intraocular pressure', 'timeFrame': '1 month postoperatively'}, {'measure': 'intraocular pressure', 'timeFrame': '3 month postoperatively'}, {'measure': 'postoperative complication', 'timeFrame': 'Early and late stages'}], 'secondaryOutcomes': [{'measure': 'Postoperative astigmatism and astigmatism axial of cornea', 'timeFrame': '1 month postoperatively'}, {'measure': 'Postoperative astigmatism and astigmatism axial of cornea', 'timeFrame': '3 month postoperatively'}, {'measure': 'endothelial cell count', 'timeFrame': '1 month postoperatively'}, {'measure': 'endothelial cell count', 'timeFrame': '3 month postoperatively'}]}, 'oversightModule': {'oversightHasDmc': False, 'isFdaRegulatedDrug': False, 'isFdaRegulatedDevice': False}, 'conditionsModule': {'conditions': ['Marfan Syndrome', 'Lens Subluxation or Dislocation']}, 'descriptionModule': {'briefSummary': 'To analyze the postoperative visual effects, and to compare the safety and efficacy of different surgical treatment with of Marfan Syndrome with subluxation lens.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['CHILD', 'ADULT'], 'maximumAge': '55 Years', 'minimumAge': '8 Years', 'samplingMethod': 'NON_PROBABILITY_SAMPLE', 'studyPopulation': 'Patients with lens dislocation of Marfan syndrome who accepted different surgical treatments', 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria:\n\n1. Patients diagnosed with MFS according to the revised Ghent etiology.\n2. refractive errors difficult to correct.\n3. pupillary block glaucoma caused by severe dislocation of the lens\n\nExclusion Criteria:\n\nKeratoconus, late glaucoma, uveitis, history of traumatic lens dislocation, and preoperative retinal rupture with or without retinal detachment (RD)'}, 'identificationModule': {'nctId': 'NCT05578469', 'briefTitle': 'Surgical Treatment of Marfan Syndrome With Subluxation Lens', 'organization': {'class': 'OTHER', 'fullName': 'Second Affiliated Hospital, School of Medicine, Zhejiang University'}, 'officialTitle': 'Effect of Different Surgical Treatment of Marfan Syndrome With Subluxation Lens', 'orgStudyIdInfo': {'id': '2022-0765'}}, 'armsInterventionsModule': {'armGroups': [{'label': 'posterior chamber intraocular lens(IOL) implantation with a Cionni capsular tension ring (CTR)', 'interventionNames': ['Procedure: surgical treatment of Marfan Syndrome with subluxation lens']}, {'label': 'sutured scleral fixation of posterior chamber IOL/ posterior chamber IOL and CTR', 'interventionNames': ['Procedure: surgical treatment of Marfan Syndrome with subluxation lens']}], 'interventions': [{'name': 'surgical treatment of Marfan Syndrome with subluxation lens', 'type': 'PROCEDURE', 'description': 'different surgical treatment of Marfan Syndrome with subluxation lens', 'armGroupLabels': ['posterior chamber intraocular lens(IOL) implantation with a Cionni capsular tension ring (CTR)', 'sutured scleral fixation of posterior chamber IOL/ posterior chamber IOL and CTR']}]}, 'contactsLocationsModule': {'locations': [{'city': 'Hangzhou', 'country': 'China', 'facility': 'Second Affiliated Hospital, Zhejiang University School of Medicine', 'geoPoint': {'lat': 30.29365, 'lon': 120.16142}}]}, 'ipdSharingStatementModule': {'ipdSharing': 'NO'}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Second Affiliated Hospital, School of Medicine, Zhejiang University', 'class': 'OTHER'}, 'responsibleParty': {'type': 'SPONSOR'}}}}