Ignite Creation Date:
2025-12-25 @ 1:11 AM
Ignite Modification Date:
2026-01-06 @ 4:49 AM
Study NCT ID:
NCT03855293
Status:
COMPLETED
Last Update Posted:
2019-02-26
First Post:
2019-02-24
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Protecting the Corneal Endothelium During Cataract Surgery Using the Anterior Capsule
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'conditionBrowseModule': {'meshes': [{'id': 'D055954', 'term': 'Corneal Endothelial Cell Loss'}], 'ancestors': [{'id': 'D003316', 'term': 'Corneal Diseases'}, {'id': 'D005128', 'term': 'Eye Diseases'}, {'id': 'D005132', 'term': 'Eye Manifestations'}, {'id': 'D011183', 'term': 'Postoperative Complications'}, {'id': 'D010335', 'term': 'Pathologic Processes'}, {'id': 'D013568', 'term': 'Pathological Conditions, Signs and Symptoms'}, {'id': 'D012816', 'term': 'Signs and Symptoms'}]}}, 'protocolSection': {'designModule': {'phases': ['NA'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'RANDOMIZED', 'maskingInfo': {'masking': 'SINGLE', 'whoMasked': ['PARTICIPANT']}, 'primaryPurpose': 'TREATMENT', 'interventionModel': 'PARALLEL'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 70}}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '2016-03-02', 'type': 'ACTUAL'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2019-02', 'completionDateStruct': {'date': '2018-04-05', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2019-02-24', 'studyFirstSubmitDate': '2019-02-24', 'studyFirstSubmitQcDate': '2019-02-24', 'lastUpdatePostDateStruct': {'date': '2019-02-26', 'type': 'ACTUAL'}, 'studyFirstPostDateStruct': {'date': '2019-02-26', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2017-04-01', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'endothelium cell loss', 'timeFrame': '1 year', 'description': 'Comparison of the lost endothelium cells in both groups'}], 'secondaryOutcomes': [{'measure': 'central corneal thickness', 'timeFrame': '1 year', 'description': 'Comparison of corneal thickness between both groups'}]}, 'oversightModule': {'isFdaRegulatedDrug': False, 'isFdaRegulatedDevice': False}, 'conditionsModule': {'conditions': ['Endothelial Cell Loss, Corneal']}, 'descriptionModule': {'briefSummary': 'Cataract surgery is one of the most frequently performed surgical procedures worldwide. Since the introduction of phacoemulsification to remove the cataractous lens, risk and complication rates of cataract surgery decreased significantly.\n\nThe phacoemulsification technique utilizes a high-intensity ultrasound energy for the fragmentation and emulsification of the lens. One of the main complications during phacoemulsification, is damaging of the endothelium due to contact with lens fragments of the nucleus following turbulent flow of irrigating solution, resulting in corneal damage, inflammation of the endothelium and corneal edema.\n\nIn this study we want to evaluate the effect of the anterior capsule, gained by capsular rhexis, as a corneal shield during phacoemulsification on the corneal endothelium.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'minimumAge': '21 Years', 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* Cataract\n* Age 21 and older\n* Written informed consent prior to surgery\n* Moderate to severe nuclear or mixed cataract\n\nExclusion Criteria:\n\n* Corneal pathologies\n* Pregnancy\n* Patients with an increased surgical risk (i.e. patients with pseudoexfoliation syndrome, patients with the potential risk of intra-operative floppy iris syndrome)'}, 'identificationModule': {'nctId': 'NCT03855293', 'briefTitle': 'Protecting the Corneal Endothelium During Cataract Surgery Using the Anterior Capsule', 'organization': {'class': 'OTHER', 'fullName': 'Vienna Institute for Research in Ocular Surgery'}, 'officialTitle': 'Protecting the Corneal Endothelium During Cataract Surgery Using the Anterior Capsule: a Prospective Randomised Double-masked Study', 'orgStudyIdInfo': {'id': 'Rhexis Protection Shield'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'OTHER', 'label': 'Study group', 'description': 'rhexis protection shield', 'interventionNames': ['Procedure: Rhexis protection shield']}, {'type': 'NO_INTERVENTION', 'label': 'Control group', 'description': 'regular surgery'}], 'interventions': [{'name': 'Rhexis protection shield', 'type': 'PROCEDURE', 'description': 'In the study group the anterior capsule will be used as a protection shield during pacoemulsifikation and removed after the phacoemulsifikation', 'armGroupLabels': ['Study group']}]}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Prim. Prof. Dr. Oliver Findl, MBA', 'class': 'OTHER'}, 'responsibleParty': {'type': 'SPONSOR_INVESTIGATOR', 'investigatorTitle': 'Prim. Prof. Dr.', 'investigatorFullName': 'Prim. Prof. Dr. Oliver Findl, MBA', 'investigatorAffiliation': 'Vienna Institute for Research in Ocular Surgery'}}}}