Ignite Creation Date:
2025-12-24 @ 7:02 PM
Ignite Modification Date:
2025-12-27 @ 8:12 AM
Study NCT ID:
NCT04447157
Status:
COMPLETED
Last Update Posted:
2020-06-30
First Post:
2020-06-23
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
The Efficacy of a 6-point Transscleral Suture Fixation of a 3-looped Haptics PC-IOL Implantation Through Scleral Pockets for Surgical Management for Microspherophakia
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'conditionBrowseModule': {'meshes': [{'id': 'C563255', 'term': 'Microspherophakia'}]}}, 'protocolSection': {'designModule': {'studyType': 'OBSERVATIONAL', 'designInfo': {'timePerspective': 'RETROSPECTIVE', 'observationalModel': 'CASE_ONLY'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 9}, 'patientRegistry': False}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '2016-07-01', 'type': 'ACTUAL'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2020-06', 'completionDateStruct': {'date': '2020-06-20', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2020-06-28', 'studyFirstSubmitDate': '2020-06-23', 'studyFirstSubmitQcDate': '2020-06-23', 'lastUpdatePostDateStruct': {'date': '2020-06-30', 'type': 'ACTUAL'}, 'studyFirstPostDateStruct': {'date': '2020-06-25', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2020-06-10', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Visual function', 'timeFrame': '6 month postoperation', 'description': 'Best corrected visual acuity (BCVA) measured using a decimal chart'}, {'measure': 'Visual function', 'timeFrame': '6 month postoperation', 'description': 'uncorrected distance visual acuity (UDVA) measured using a decimal chart'}, {'measure': 'Intraocular pressure', 'timeFrame': '6 month postoperation', 'description': 'intraocular pressure measured using non-contact tonometer'}, {'measure': 'PCIOL tilt degree', 'timeFrame': '6 month postoperation', 'description': 'PCIOL tilt degree measured using Ultrasound biomicroscope'}, {'measure': 'PCIOL decentration distance', 'timeFrame': '6 month postoperation', 'description': 'PCIOL decentration distance measured using Ultrasound biomicroscope'}, {'measure': 'Endothelial cell density', 'timeFrame': '6 month postoperation', 'description': 'Endothelial cell density was measured by specular microscopy'}, {'measure': 'Anterior chamber depth', 'timeFrame': '6 month postoperation', 'description': 'Anterior chamber depth measured using Ultrasound biomicroscope'}]}, 'oversightModule': {'isFdaRegulatedDrug': False, 'isFdaRegulatedDevice': False}, 'conditionsModule': {'conditions': ['Microspherophakia']}, 'descriptionModule': {'briefSummary': 'By comparing the preoperative data and postoperative data of 9 patients of microspherophakia, we concluded that the 6-point transscleral suture fixation of a 3-looped haptics posterior chamber intraocular lens (PC-IOL) through scleral pockets was a feasible method of PC-IOL implantation in the surgical treatment of microspherophakia.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['CHILD', 'ADULT', 'OLDER_ADULT'], 'maximumAge': '80 Years', 'minimumAge': '10 Years', 'samplingMethod': 'NON_PROBABILITY_SAMPLE', 'studyPopulation': 'A retrospective study was conducted on 9 patients (18 eyes) diagnosed with microspherophakia in Eye Center of the Second Affiliated Hospital, Zhejiang University School of Medicine from July 2016 to April 2020.', 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* Microspherophakia was diagnosed and lens diameter\\<9mm;\n* The lens subluxation was beyond the range of one quadrant and glasses cannot correct the vision;\n* Lens dislocated into the anterior chamber;\n* Lens dislocation caused elevated intraocular pressure (IOP);\n* The lens contacted the corneal endothelium;\n* Cataract;\n* Corneal endothelial cell density\\>1000/mm2;\n* The fundus was normal without retinal detachment, severe macular disease and optic nerve atrophy；\n* There was possible improvement in postoperative visual acuity measured by retinometer.\n\nExclusion Criteria:\n\n* The lens is centered and the position of the lens is stable;\n* Glasses can correct the vision obviously;\n* The reason for the elevated IOP was independent with the lens;\n* A high possibility of corneal decompensation after surgery;\n* Fundus function was poor and it is not expected to improve the vision after surgery;\n* Combined with other ocular diseases which were not suitable for IOL implantation;\n* Combined with a systemic disease that the patient cannot tolerate the surgery.'}, 'identificationModule': {'nctId': 'NCT04447157', 'briefTitle': 'The Efficacy of a 6-point Transscleral Suture Fixation of a 3-looped Haptics PC-IOL Implantation Through Scleral Pockets for Surgical Management for Microspherophakia', 'organization': {'class': 'OTHER', 'fullName': 'Second Affiliated Hospital, School of Medicine, Zhejiang University'}, 'officialTitle': 'The Efficacy of a 6-point Transscleral Suture Fixation of a 3-looped Haptics PC-IOL Implantation Through Scleral Pockets for Surgical Management for Microspherophakia', 'orgStudyIdInfo': {'id': 'xuwen2020-465'}}, 'armsInterventionsModule': {'armGroups': [{'label': 'Microspherophakia', 'description': 'This is a non-interventional study(NIS). All the patients diagnosed as microspherophakia are included in the study and recieved intraocular lens implantation'}]}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Second Affiliated Hospital, School of Medicine, Zhejiang University', 'class': 'OTHER'}, 'responsibleParty': {'type': 'SPONSOR'}}}}