Ignite Creation Date:
2025-12-24 @ 5:08 PM
Ignite Modification Date:
2026-01-02 @ 9:37 AM
Study NCT ID:
NCT04839250
Status:
COMPLETED
Last Update Posted:
2022-05-12
First Post:
2021-04-04
Is Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Difference Between Three-Dimensional Heads-Up Surgery System and Traditional Surgery Methods in Cataract Surgery
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'conditionBrowseModule': {'meshes': [{'id': 'D002386', 'term': 'Cataract'}], 'ancestors': [{'id': 'D007905', 'term': 'Lens Diseases'}, {'id': 'D005128', 'term': 'Eye Diseases'}]}}, 'protocolSection': {'designModule': {'phases': ['NA'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'RANDOMIZED', 'maskingInfo': {'masking': 'SINGLE', 'whoMasked': ['PARTICIPANT']}, 'primaryPurpose': 'TREATMENT', 'interventionModel': 'PARALLEL'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 60}}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '2021-02-01', 'type': 'ACTUAL'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2022-05', 'completionDateStruct': {'date': '2021-10-31', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2022-05-07', 'studyFirstSubmitDate': '2021-04-04', 'studyFirstSubmitQcDate': '2021-04-08', 'lastUpdatePostDateStruct': {'date': '2022-05-12', 'type': 'ACTUAL'}, 'studyFirstPostDateStruct': {'date': '2021-04-09', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2021-10-31', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'change of corneal incision from 1day after surgery to 1 months', 'timeFrame': 'up to 1day,1week,1 month', 'description': "the shape and length of the corneal incision ，if descemet's layer detachment happens"}, {'measure': 'corneal endothelial cell density', 'timeFrame': 'up to 1 month', 'description': 'the number of corneal endothelial cells per unit area'}], 'secondaryOutcomes': [{'measure': 'best corrected visual acuity', 'timeFrame': 'up to 1 month', 'description': 'best corrected visual acuity'}, {'measure': 'change from baseline central corneal thickness at 1 months', 'timeFrame': 'up to 1 day,1 week,1 month', 'description': 'thickness in micrometer'}, {'measure': 'change from baseline corneal incision thickness at 1 months', 'timeFrame': 'up to 1 day,1 week,1 month', 'description': 'Thickness of corneal incision'}]}, 'oversightModule': {'oversightHasDmc': False, 'isFdaRegulatedDrug': False, 'isFdaRegulatedDevice': False}, 'conditionsModule': {'keywords': ['three-dimensional surgery', 'microsurgery', 'phacoemulsification'], 'conditions': ['Cataract']}, 'referencesModule': {'references': [{'pmid': '35749016', 'type': 'DERIVED', 'citation': 'Zhu Z, Chang P, Huang F, Shen S, Zhao X, Ji X, Zhao YE. Comparison of Three-Dimensional Surgical System Versus Binocular Microscope for Clear Corneal Incision in Cataract Surgery. Ophthalmol Ther. 2022 Aug;11(4):1589-1600. doi: 10.1007/s40123-022-00537-4. Epub 2022 Jun 24.'}]}, 'descriptionModule': {'briefSummary': 'To evaluate the differences between three-Dimensional heads-Up surgery system and traditional surgery methods of cataract surgery', 'detailedDescription': 'To evaluate the differences between three-Dimensional heads-Up surgery system and traditional surgery methods of cataract surgery.Prospective research.One eligible eye from patients having cataract surgery performed using the 3-D head-up technique were included in the study as an experimental group,in the meanwhile eyes performed cataract surgery by traditional microsurgery included as a control group.All eyes in the study are operated by the same doctor. Corneal incision form,corneal endothelial cell density and best corrected visual acuity are included to evaluate the results of cataract surgery.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'maximumAge': '90 Years', 'minimumAge': '50 Years', 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria:\n\n1. Diagnose age-related cataract;\n2. Plan to perform phacoemulsification of cataract with intraocular lens implantation;\n3. Willing to cooperate with the re-examination of 1 day, 1 week, and 1 month after surgery;\n4. Able to understand and independently fill in the informed consent form and postoperative follow-up plan.\n\nExclusion Criteria:\n\n1. Cataract caused by other reasons;\n2. Fundus diseases such as severe diabetic retinopathy, high myopic retinopathy or macular degeneration;\n3. Corneal diseases, corneal endothelial cells \\<1800/mm2;\n4. Small palpebral fissure;\n5. Those with a history of glaucoma, uveitis, eye trauma or eye surgery;\n6. Those who cannot cooperate with the inspection and have not completed the one-month follow-up'}, 'identificationModule': {'nctId': 'NCT04839250', 'briefTitle': 'Difference Between Three-Dimensional Heads-Up Surgery System and Traditional Surgery Methods in Cataract Surgery', 'organization': {'class': 'OTHER', 'fullName': 'Wenzhou Medical University'}, 'officialTitle': 'Study on The Difference Between Three-Dimensional Heads-Up Surgery System and Traditional Surgery Methods in Cataract Surgery', 'orgStudyIdInfo': {'id': '3D system-CPJ'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'EXPERIMENTAL', 'label': 'cataract surgery performed by heads-up method', 'description': '3D heads-up surgery was performed under the NGENUITY® 3D visualization system', 'interventionNames': ['Procedure: heads-up method']}, {'type': 'NO_INTERVENTION', 'label': 'Traditional surgery', 'description': 'Traditional surgery was performed under a surgical microscope.'}], 'interventions': [{'name': 'heads-up method', 'type': 'PROCEDURE', 'description': '3D surgical video system, which includes Alcon NGENUITY 3D visualization system (Alcon, Fort Worth, TX) and Leica M822 and M844 microscopes (Leica Microsystems, Wetzlar, Germany),can be used to perform head-up phacoemulsification combined with intraocular lens implantation surgery.', 'armGroupLabels': ['cataract surgery performed by heads-up method']}]}, 'contactsLocationsModule': {'locations': [{'city': 'Wenzhou', 'state': 'Zhejiang', 'country': 'China', 'facility': 'Eye Hospital of Wenzhou Medical College', 'geoPoint': {'lat': 27.99942, 'lon': 120.66682}}]}, 'ipdSharingStatementModule': {'ipdSharing': 'NO'}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Wenzhou Medical University', 'class': 'OTHER'}, 'responsibleParty': {'type': 'PRINCIPAL_INVESTIGATOR', 'investigatorTitle': 'Vice president of Eye Hospital of Wenzhou Medical University, Wenzhou Medical University', 'investigatorFullName': 'Yune Zhao', 'investigatorAffiliation': 'Wenzhou Medical University'}}}}