Ignite Creation Date:
2025-12-25 @ 2:02 AM
Ignite Modification Date:
2026-02-01 @ 2:06 PM
Study NCT ID:
NCT01553760
Status:
UNKNOWN
Last Update Posted:
2012-03-14
First Post:
2012-02-19
Is Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
The Use of an Anterior Chamber Maintainer as a Sole Fluid Source in Micro Incision Cataract Surgery as Compared to a Standard Phacoemulsification Procedure
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': 'NON_RANDOMIZED', 'maskingInfo': {'masking': 'NONE'}, 'interventionModel': 'PARALLEL'}, 'enrollmentInfo': {'type': 'ESTIMATED', 'count': 20}}, 'statusModule': {'overallStatus': 'UNKNOWN', 'lastKnownStatus': 'NOT_YET_RECRUITING', 'startDateStruct': {'date': '2012-03'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2012-03', 'completionDateStruct': {'date': '2013-03', 'type': 'ESTIMATED'}, 'lastUpdateSubmitDate': '2012-03-13', 'studyFirstSubmitDate': '2012-02-19', 'studyFirstSubmitQcDate': '2012-03-13', 'lastUpdatePostDateStruct': {'date': '2012-03-14', 'type': 'ESTIMATED'}, 'studyFirstPostDateStruct': {'date': '2012-03-14', 'type': 'ESTIMATED'}, 'primaryCompletionDateStruct': {'date': '2013-03', 'type': 'ESTIMATED'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Corneal temperature', 'timeFrame': 'up to 12 months', 'description': 'Continuous corneal temperature will be measured during cataract surgery using an infra red thermal imaging system'}], 'secondaryOutcomes': [{'measure': 'Anterior chamber stability', 'timeFrame': 'up to 12 months', 'description': 'Anterior chamber stability will be accessed during cataract surgery by the surgeon and post op by two different observers using surgery video record.'}]}, 'oversightModule': {'oversightHasDmc': False}, 'conditionsModule': {'keywords': ['Cataract', 'TRI-MICS', 'ACM', 'MICS', 'phacoemulsification'], 'conditions': ['Cataract']}, 'descriptionModule': {'briefSummary': 'The purpose of this study is to compare the use of an Anterior Chamber Maintainer (ACM) as the sole fluid source in phacoemulsification micro incision cataract surgery (using 1.1mm corneal incision) as opposed to conventional coaxial phacoemulsification (using 2.4mm corneal incision).', 'detailedDescription': "Three-port Micro Incision Cataract Surgery (Tri-MICS) is a technique suggested by Professor Assia. The idea (principle) behind the Tri-MICS technique is the use of a sleeveless phaco needle which is introduced via a tiny incision (1.1mm). An additional corneal incision is made for the introduction of a second surgical instrument, and a third for an ACM as an exclusive source for the infusion - this saves the need for an additional instrument. The ACM that will be used in this study (AVI New York) is a small metal tube with an external diameter of 1.1 mm, and an internal diameter of 0.9 mm and was developed specifically for this use. This type of ACM has been used in hundreds of surgeries and has been found to be both effective and safe.\n\nThis procedure has 4 clear advantages:\n\n1. The implementation of three corneal incisions, 1.1 mm wide with an angle of approximately 120 degrees between them - neutrality regarding astigmatism versus the Biaxial-MICS.\n2. This procedure does not require any special medical instruments, for example; new phaco instruments which are specifically adapted for the MICS approach at the cost of tens of thousands of dollars.\n3. This procedure allows a free use of the surgeon's second hand.\n4. A fixed intraocular infusion keeps the intraocular pressure (IOP) and anterior chamber volume constant and stable."}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'minimumAge': '18 Years', 'healthyVolunteers': True, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* Bilateral Cataract\n* Ability to understand and sign on an inform consent form.\n* whiling to undergo bilateral cataract surgery.\n\nExclusion Criteria:\n\n* Mature Cataract\n* PXF\n* Uveitis\n* Corneal Pathology\n* Endothelial cell density\\<1500 cells/mm\n* Glaucoma\n* Extreme Hyperopia / shallow anterior chamber\n* Extreme Myopia\n* s/p Ophthalmic Trauma / Surgery\n* Allergy to Penicillin / IOD'}, 'identificationModule': {'nctId': 'NCT01553760', 'briefTitle': 'The Use of an Anterior Chamber Maintainer as a Sole Fluid Source in Micro Incision Cataract Surgery as Compared to a Standard Phacoemulsification Procedure', 'organization': {'class': 'OTHER', 'fullName': 'Meir Medical Center'}, 'orgStudyIdInfo': {'id': '0163-11-MMC'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'EXPERIMENTAL', 'label': 'Tri-MICS', 'interventionNames': ['Procedure: Phacoemulsification using an ACM as the sole fluid source']}, {'type': 'ACTIVE_COMPARATOR', 'label': 'Conventional Phaco', 'interventionNames': ['Procedure: Conventional Phaco']}], 'interventions': [{'name': 'Phacoemulsification using an ACM as the sole fluid source', 'type': 'PROCEDURE', 'description': 'A Tri-MICS system will be used with a sleeveless Kelman 20G tip through a 1.1mm CCI. A specialized 19G anterior chamber maintainer, with thin walls and a large internal diameter of 0.9mm will be inserted through a 1.1mm CCI.', 'armGroupLabels': ['Tri-MICS']}, {'name': 'Conventional Phaco', 'type': 'PROCEDURE', 'description': 'a conventional Phaco with sleeved Kelman 20G tip, through a 2.4mm CCI', 'armGroupLabels': ['Conventional Phaco']}]}, 'contactsLocationsModule': {'locations': [{'city': 'Kfar Saba', 'country': 'Israel', 'contacts': [{'name': 'Adi Abulafia, MD', 'role': 'CONTACT', 'email': 'adi.abulafia@gmail.com', 'phone': '+972-9-7472154'}, {'name': 'Yafit Steren, SC', 'role': 'CONTACT', 'email': 'yafit.steren@clalit.org.il', 'phone': '+972-9-7471707'}, {'name': 'Ehud Assia, MD', 'role': 'SUB_INVESTIGATOR'}, {'name': 'Shay Ofir, MD', 'role': 'SUB_INVESTIGATOR'}, {'name': 'Avner Belkin, MD', 'role': 'SUB_INVESTIGATOR'}, {'name': 'Noa Gefen, MD', 'role': 'SUB_INVESTIGATOR'}, {'name': 'Adi Michaeli, MD', 'role': 'SUB_INVESTIGATOR'}], 'facility': 'Meir Medical Center', 'geoPoint': {'lat': 32.175, 'lon': 34.90694}}]}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Meir Medical Center', 'class': 'OTHER'}, 'responsibleParty': {'type': 'PRINCIPAL_INVESTIGATOR', 'investigatorTitle': 'MD', 'investigatorFullName': 'Abulafia Adi', 'investigatorAffiliation': 'Meir Medical Center'}}}}