Ignite Creation Date:
2025-12-25 @ 2:38 AM
Ignite Modification Date:
2025-12-26 @ 6:05 PM
Study NCT ID:
NCT03437434
Status:
UNKNOWN
Last Update Posted:
2018-02-19
First Post:
2018-01-21
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Scleral Fixation of BunnyLens With GoreTex Suture- Initial Results
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'conditionBrowseModule': {'meshes': [{'id': 'D001035', 'term': 'Aphakia'}], 'ancestors': [{'id': 'D007905', 'term': 'Lens Diseases'}, {'id': 'D005128', 'term': 'Eye Diseases'}]}, 'interventionBrowseModule': {'meshes': [{'id': 'D014792', 'term': 'Visual Acuity'}, {'id': 'D012029', 'term': 'Refraction, Ocular'}, {'id': 'D033401', 'term': 'Microscopy, Acoustic'}], 'ancestors': [{'id': 'D014787', 'term': 'Vision Tests'}, {'id': 'D003941', 'term': 'Diagnostic Techniques, Ophthalmological'}, {'id': 'D019937', 'term': 'Diagnostic Techniques and Procedures'}, {'id': 'D003933', 'term': 'Diagnosis'}, {'id': 'D009799', 'term': 'Ocular Physiological Phenomena'}, {'id': 'D055620', 'term': 'Optical Phenomena'}, {'id': 'D055585', 'term': 'Physical Phenomena'}, {'id': 'D008853', 'term': 'Microscopy'}, {'id': 'D003952', 'term': 'Diagnostic Imaging'}, {'id': 'D014463', 'term': 'Ultrasonography'}, {'id': 'D008919', 'term': 'Investigative Techniques'}]}}, 'protocolSection': {'designModule': {'studyType': 'OBSERVATIONAL', 'designInfo': {'timePerspective': 'RETROSPECTIVE', 'observationalModel': 'COHORT'}, 'enrollmentInfo': {'type': 'ESTIMATED', 'count': 40}, 'patientRegistry': False}, 'statusModule': {'overallStatus': 'UNKNOWN', 'lastKnownStatus': 'RECRUITING', 'startDateStruct': {'date': '2017-04-24', 'type': 'ACTUAL'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2018-02', 'completionDateStruct': {'date': '2018-04-24', 'type': 'ESTIMATED'}, 'lastUpdateSubmitDate': '2018-02-11', 'studyFirstSubmitDate': '2018-01-21', 'studyFirstSubmitQcDate': '2018-02-11', 'lastUpdatePostDateStruct': {'date': '2018-02-19', 'type': 'ACTUAL'}, 'studyFirstPostDateStruct': {'date': '2018-02-19', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2018-03-24', 'type': 'ESTIMATED'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Distance Visual Acuity', 'timeFrame': 'Up to 24 months from surgery.', 'description': 'Degree of Visual Acuity is measured in LogMar (-0.3 to1) and by Decimal Value (0.0-2.0)'}, {'measure': 'Ocular Refraction', 'timeFrame': 'Up to 24 months from surgery.', 'description': 'Refraction of the Ocular surfaces, measured in sphere, cylinder and axis.'}], 'secondaryOutcomes': [{'measure': 'Slit Lamp Biomicroscopy', 'timeFrame': 'Up to 24 months from surgery.', 'description': 'Slit lamp examination of the anterior and posterior segments.'}]}, 'oversightModule': {'oversightHasDmc': True, 'isFdaRegulatedDrug': False, 'isFdaRegulatedDevice': False}, 'conditionsModule': {'conditions': ['Aphakia, Acquired']}, 'descriptionModule': {'briefSummary': 'This study evaluates the Visual Acuity and refraction of patients post 4-point Scleral fixation of BunnyLens (Intra Ocular Lens- IOL) with GoreTex sutures. All patients underwent secondary IOL implantation or IOL exchange during 2014-2017.', 'detailedDescription': '4 point scleral fixation of PC- IOL (Posterior Chamber-PC) BunnyLens with Gore-Tex sutures is a surgical technique for implanting IOL in patients with capsular support absence, due to trauma, abnormal anterior chamber, IOL dislocation, or ciliary zonule defect.\n\nThe 4 point fixation enables to align the PC- IOL with minimal vertical and horizontal deviation;The Gore-Tex sutures maintain stable scleral fixation with no suture erosion or breakage.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['CHILD', 'ADULT', 'OLDER_ADULT'], 'maximumAge': '99 Years', 'minimumAge': '15 Years', 'samplingMethod': 'NON_PROBABILITY_SAMPLE', 'studyPopulation': 'Patients who are capable of inform consent and are eligible according to the inclusion criteria.', 'healthyVolunteers': True, 'eligibilityCriteria': "Inclusion Criteria:\n\n* patients that underwent secondary cataract surgery or IOL replacement and BunnyLens fixation with Gore-Tex sutures.\n\nExclusion Criteria:\n\n* Lack of Cooperation, death, severe physical or mental illness, patient's request to withdraw of the clinical trial."}, 'identificationModule': {'nctId': 'NCT03437434', 'briefTitle': 'Scleral Fixation of BunnyLens With GoreTex Suture- Initial Results', 'organization': {'class': 'OTHER', 'fullName': 'Barzilai Medical Center'}, 'officialTitle': 'Gore-Tex Suture and BunnyLens Scleral Fixation - Historical Retrospective Trial', 'orgStudyIdInfo': {'id': '114-16-BRZ'}}, 'armsInterventionsModule': {'armGroups': [{'label': 'BunnyLens and Gore-Tex suture', 'description': 'All patients Underwent 4 point PC-IOL scleral fixation with Gore-Tex sutures', 'interventionNames': ['Other: Visual Acuity']}], 'interventions': [{'name': 'Visual Acuity', 'type': 'OTHER', 'otherNames': ['Refraction', 'Biomicroscopy'], 'description': 'Ocular Examination', 'armGroupLabels': ['BunnyLens and Gore-Tex suture']}]}, 'contactsLocationsModule': {'locations': [{'zip': '7830604', 'city': 'Ashkelon', 'status': 'RECRUITING', 'country': 'Israel', 'contacts': [{'name': 'Ornit Cohen, M.Med.Sc', 'role': 'CONTACT', 'email': 'ornitc@bmc.gov.il', 'phone': '972 8 6746146'}], 'facility': 'Barzilai University Medical Center', 'geoPoint': {'lat': 31.66926, 'lon': 34.57149}}], 'centralContacts': [{'name': 'David Hauser, MD', 'role': 'CONTACT', 'email': 'dehauser@gmail.com', 'phone': '972-526700010'}], 'overallOfficials': [{'name': 'David Hauser, MD', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': 'Barzilai University Medical Center'}]}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'DAVID HAUSER', 'class': 'OTHER'}, 'responsibleParty': {'type': 'SPONSOR_INVESTIGATOR', 'investigatorTitle': 'Retina Ophthalmologist', 'investigatorFullName': 'DAVID HAUSER', 'investigatorAffiliation': 'Barzilai Medical Center'}}}}