Ignite Creation Date:
2025-12-25 @ 12:52 AM
Ignite Modification Date:
2026-01-02 @ 9:19 AM
Study NCT ID:
NCT01396967
Status:
UNKNOWN
Last Update Posted:
2011-08-03
First Post:
2011-07-13
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Trying a New Device for Performing Capsulorhexis in Cataract Surgery Surgery
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'conditionBrowseModule': {'meshes': [{'id': 'D005128', 'term': 'Eye Diseases'}, {'id': 'D002386', 'term': 'Cataract'}], 'ancestors': [{'id': 'D007905', 'term': 'Lens Diseases'}]}, 'interventionBrowseModule': {'meshes': [{'id': 'D013514', 'term': 'Surgical Procedures, Operative'}]}}, 'protocolSection': {'designModule': {'phases': ['PHASE1'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'NA', 'maskingInfo': {'masking': 'NONE'}, 'interventionModel': 'SINGLE_GROUP'}, 'enrollmentInfo': {'type': 'ESTIMATED', 'count': 20}}, 'statusModule': {'overallStatus': 'UNKNOWN', 'lastKnownStatus': 'ENROLLING_BY_INVITATION', 'startDateStruct': {'date': '2011-07'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2011-08', 'completionDateStruct': {'date': '2011-12', 'type': 'ESTIMATED'}, 'lastUpdateSubmitDate': '2011-08-02', 'studyFirstSubmitDate': '2011-07-13', 'studyFirstSubmitQcDate': '2011-07-17', 'lastUpdatePostDateStruct': {'date': '2011-08-03', 'type': 'ESTIMATED'}, 'studyFirstPostDateStruct': {'date': '2011-07-19', 'type': 'ESTIMATED'}, 'primaryCompletionDateStruct': {'date': '2011-12', 'type': 'ESTIMATED'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'capsulorhexis must be round and with regular edge and no tears', 'timeFrame': 'Post operative follow up will be done as usually, one day, one week, 3 weeks and six weeks after operation', 'description': 'As the title of this experiment:"The trying a new device for performing capsulorhexis in cataract surgery".Becuase we are not changing the protocol of Cataract surgery,the outcome measure of this experiment is the efficiency of this device, the safety and the simplicity of the use the device inorder to give a simple and safe solution for capsulorhexis.Therefor the outcome measure will be IOL stability, the shape of capsulorexis and intra ocular post operative inflammation if will occur. The trail is not comparative.'}]}, 'oversightModule': {'oversightHasDmc': True}, 'conditionsModule': {'keywords': ['capsulorhexis'], 'conditions': ['Eye Disease', 'Cataract']}, 'descriptionModule': {'briefSummary': 'During cataract operations a capsulorhexis is being performed. This is done in order to enable the removal of lens material while keeping the capsule intact in order to put inside the lens capsule an artificial intra ocular lens.\n\nThe capsulorhexis must be round and with regular edge and no tears. While performing a cataract surgery we use phako emulsification machine that sends an ultrasonic wave that creaks the lens nucleus and at the same time irrigates the anterior chamber of the eye and sucks the fluid and the lens material of the creaked lens.\n\nThe round shape and the regularity of the capsulorhexis are a must in these surgeries since the lens capsule must stay intact and stable in order to enable the phacoemulsification and the implant of the artificial lens.\n\nToday capsulorhexis are done with a bent needle or with special forceps; the act of capsulorhexis is delicate, sometime un predicted and difficult to teach. The learning curve is relatively long and difficult.\n\nThe proposed device enables a capsulorhexis which is round and has regular edges, done almost automatically and is predicted. The learning curve is short and easy. The capsulorhexis is done through the original operating wound with no need to widen it.', 'detailedDescription': "Planed Procedure\n\n20 patients will be tested in this trail.\n\nConsecutive patients that have senile cataract will be examined preoperatively as is done usually and the data of the examination will be collected/ a special attention will be given to the type of cataract and lens stability.\n\nSystemic diseases will not be considered as exclusion criteria.\n\nPatients with dens or mature cataract will be excluded.\n\nPatients will be explained about the new device and those who will agree will sign a consent form.\n\nDuring the cataract surgery all steps will be done as usually except of the capsulorhexis which will be done by using the new device.\n\nThe capsulorhexis will be photographed for further evaluation by a microscope camera.\n\nAfter the operation the surgeon will record his impression about the convenience of using the new device, the shape and form of the capsulorhexis and its stability and any other relevant information.\n\nPost operative follow up will be done as usually, one day, one week, 3 weeks and six weeks after operation. The results of those examinations will be recorded and collected with special attention of IOL stability, the shape of capsulorhexis and intra ocular post operative inflammation if will occur.\n\nThe data, including the surgeons' comments, shape and form of capsulorhexis IOL stability and the rest will be collected and processed.\n\nIn case in which the use of the device will not perform a round and regular capsulorhexis, or instability of the capsule will occur or a un predicted intraocular inflammation will be seen the trail will be stopped immediately"}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'maximumAge': '90 Years', 'minimumAge': '20 Years', 'healthyVolunteers': True, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* senile cataract\n\nExclusion Criteria:\n\n* dens or mature cataract trauma congenital instability of the lens(phacodonesis,TXF)'}, 'identificationModule': {'nctId': 'NCT01396967', 'briefTitle': 'Trying a New Device for Performing Capsulorhexis in Cataract Surgery Surgery', 'organization': {'class': 'OTHER_GOV', 'fullName': 'Ziv Hospital'}, 'officialTitle': 'The Efficiency of a New Device for Performing Capsulorhexis in Cataract Surgery', 'orgStudyIdInfo': {'id': 'ZIV-0065-10'}}, 'armsInterventionsModule': {'interventions': [{'name': 'surgery', 'type': 'DEVICE', 'otherNames': ['V.R.hexis-1'], 'description': 'cataract surgery'}]}, 'contactsLocationsModule': {'locations': [{'city': 'Safed', 'country': 'Israel', 'facility': 'Ziv Medical Center', 'geoPoint': {'lat': 32.96465, 'lon': 35.496}}], 'overallOfficials': [{'name': 'Joseph Pikkel, Md', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': 'Ziv Medical Center Sefat Israel'}]}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Ziv Hospital', 'class': 'OTHER_GOV'}, 'responsibleParty': {'oldNameTitle': 'Joseph Pikkel MD', 'oldOrganization': 'Ziv Hospital'}}}}