Ignite Creation Date:
2025-12-25 @ 12:19 AM
Ignite Modification Date:
2025-12-25 @ 10:22 PM
Study NCT ID:
NCT06712758
Status:
RECRUITING
Last Update Posted:
2024-12-02
First Post:
2024-11-26
Is NOT Gene Therapy:
False
Has Adverse Events:
False
Brief Title:
Low Intraocular Pressure Cataract Surgery With Zeiss Quatera in Glaucoma Patients
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'conditionBrowseModule': {'meshes': [{'id': 'D002386', 'term': 'Cataract'}, {'id': 'D005901', 'term': 'Glaucoma'}], 'ancestors': [{'id': 'D007905', 'term': 'Lens Diseases'}, {'id': 'D005128', 'term': 'Eye Diseases'}, {'id': 'D009798', 'term': 'Ocular Hypertension'}]}}, 'protocolSection': {'designModule': {'studyType': 'OBSERVATIONAL', 'designInfo': {'timePerspective': 'PROSPECTIVE', 'observationalModel': 'CASE_ONLY'}, 'enrollmentInfo': {'type': 'ESTIMATED', 'count': 10}, 'patientRegistry': False}, 'statusModule': {'overallStatus': 'RECRUITING', 'startDateStruct': {'date': '2024-11-12', 'type': 'ACTUAL'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2024-11', 'completionDateStruct': {'date': '2025-12-31', 'type': 'ESTIMATED'}, 'lastUpdateSubmitDate': '2024-11-29', 'studyFirstSubmitDate': '2024-11-26', 'studyFirstSubmitQcDate': '2024-11-29', 'lastUpdatePostDateStruct': {'date': '2024-12-02', 'type': 'ACTUAL'}, 'studyFirstPostDateStruct': {'date': '2024-12-02', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2025-12-31', 'type': 'ESTIMATED'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Complication rate during cataract surgery', 'timeFrame': 'Month 1', 'description': 'Complication rate during cataract surgery'}], 'secondaryOutcomes': [{'measure': 'Best corrected visual acuity', 'timeFrame': 'Month 1', 'description': 'Best corrected visual acuity will be determined and recorded at the preoperative, day 1, week\n\n1 and month 1 visit.'}, {'measure': 'Intraocular pressure', 'timeFrame': '1 month', 'description': 'The intraocular pressure will be measured at the preoperative, day 1, week 1 and month 1 visit. Ocular hypertension will reported.'}, {'measure': 'Retinal nerve fiber layer thickness', 'timeFrame': '1 year', 'description': 'Optical Coherence Tomography will be performed at the preoperative and month 1 visit. Any abnormalities will be described.'}, {'measure': 'Visual field mean deviation', 'timeFrame': 'Month 1', 'description': 'The visual field examination will be performed at the preoperative and month 1 visit. Any abnormalities will be described.'}]}, 'oversightModule': {'oversightHasDmc': False, 'isFdaRegulatedDrug': False, 'isFdaRegulatedDevice': False}, 'conditionsModule': {'keywords': ['intra ocular pressure', 'cataract', 'Quatera', 'glaucoma'], 'conditions': ['Cataract', 'Glaucoma']}, 'descriptionModule': {'briefSummary': 'You were selected to participate in this observational study because you suffer from glaucoma and cataracts. For the cataract you will have cataract surgery. This study will not affect your treatment, it will only collect data on what is performed before, during and after the procedure.\n\nThe aim of this data collection is to demonstrate the safety of a new generation of cataract surgical devices in patients who also suffer from glaucoma. They are glaucoma patients who have an increased sensitivity to eye pressure increases both during and after surgery. The new surgical device makes it possible to safely perform cataract surgery under low pressures. This could, at least theoretically, provide an advantage for patients who also suffer from glaucoma.', 'detailedDescription': 'Cataract surgery is a highly standardized procedure. However a new phacoemulsification system "Quatera 700" has been developed by Carl Zeiss Meditec. The system has a unique patented QUATTRO Pump that directly controls infusion and aspiration and enables a synchronous change in both. It has four membranes, which directly regulate infusion and aspiration and maintain a pre-set intraocular pressure (IOP), resulting in a stable anterior chamber during the surgery. The membranes are activated by pneumatic pressure regulated by sensors that measure infusion and aspiration flows which allows the system to determine and compensate for incisional leakage as well. This innovative pump system allows surgeons to significantly decrease the intra-ocular pressure during cataract surgery. In respect to competitive devices on the market, the Quatera system is able to operate with pressure four times lower than average. Especially in glaucoma patients (patients suffering from optic nerve head damage due to elevated intraocular pressures), performing surgery with lower intra-ocular pressures would help in avoiding extra nerve fiber layer damage and overall safety of the surgery.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['CHILD', 'ADULT', 'OLDER_ADULT'], 'samplingMethod': 'NON_PROBABILITY_SAMPLE', 'studyPopulation': 'Patients from Dr. Koen Willekens at Visionair Oogzorg.', 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* Patients diagnosed with glaucoma that are diagnosed with age-related cataract\n\nExclusion Criteria:\n\n* Unwilling to sign informed consent\n* Functionally monophtalmic patient\n* Endothelial dystrophy\n* Active uveitis\n* Known corticosteroid responder\n* Presence of uncontrolled systemic disease'}, 'identificationModule': {'nctId': 'NCT06712758', 'briefTitle': 'Low Intraocular Pressure Cataract Surgery With Zeiss Quatera in Glaucoma Patients', 'organization': {'class': 'OTHER', 'fullName': 'Visionair Oogzorg'}, 'officialTitle': 'Low Intraocular Pressure Cataract Surgery With Zeiss Quatera in Glaucoma Patients. Prospective, Investigator Initiated and Observational Case Series', 'orgStudyIdInfo': {'id': 'Quatera'}}, 'armsInterventionsModule': {'armGroups': [{'label': 'Glaucoma patients in need of cataract surgery', 'description': 'Cataract surgery'}]}, 'contactsLocationsModule': {'locations': [{'zip': '2400', 'city': 'Geel', 'status': 'RECRUITING', 'country': 'Belgium', 'contacts': [{'name': 'Sien Boons', 'role': 'CONTACT', 'email': 'sb@visionairoogzorg.be', 'phone': '+3214808311'}, {'name': 'Koen Willekens, Prof. Dr.', 'role': 'CONTACT', 'email': 'kw@visionairoogzorg.be', 'phone': '+3214808311'}, {'name': 'Koen Willekens, Prof. Dr.', 'role': 'PRINCIPAL_INVESTIGATOR'}], 'facility': 'Visionair Oogzorg', 'geoPoint': {'lat': 51.16557, 'lon': 4.98917}}], 'centralContacts': [{'name': 'Koen Willekens, Prof', 'role': 'CONTACT', 'email': 'kw@visionairoogzorg.be', 'phone': '003214808311'}, {'name': 'Sien Boons', 'role': 'CONTACT', 'email': 'sb@visionairoogzorg.be', 'phone': '003216715634'}], 'overallOfficials': [{'name': 'Koen Willekens', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': 'Visionair Oogzorg'}]}, 'ipdSharingStatementModule': {'ipdSharing': 'UNDECIDED'}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Visionair Oogzorg', 'class': 'OTHER'}, 'responsibleParty': {'type': 'PRINCIPAL_INVESTIGATOR', 'investigatorTitle': 'Professor Doctor', 'investigatorFullName': 'Koen Willekens', 'investigatorAffiliation': 'Visionair Oogzorg'}}}}