Ignite Creation Date:
2025-12-24 @ 6:31 PM
Ignite Modification Date:
2025-12-27 @ 7:56 PM
Study NCT ID:
NCT04776057
Status:
UNKNOWN
Last Update Posted:
2022-10-13
First Post:
2021-02-25
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Rotation Stability of Toric Intraocularlens (IOL) Compared Sitting Against Lying After Cataract Operation
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'conditionBrowseModule': {'meshes': [{'id': 'D001251', 'term': 'Astigmatism'}], 'ancestors': [{'id': 'D012030', 'term': 'Refractive Errors'}, {'id': 'D005128', 'term': 'Eye Diseases'}]}}, 'protocolSection': {'designModule': {'phases': ['NA'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'RANDOMIZED', 'maskingInfo': {'masking': 'NONE'}, 'primaryPurpose': 'TREATMENT', 'interventionModel': 'PARALLEL'}, 'enrollmentInfo': {'type': 'ESTIMATED', 'count': 14}}, 'statusModule': {'overallStatus': 'UNKNOWN', 'lastKnownStatus': 'RECRUITING', 'startDateStruct': {'date': '2021-02-01', 'type': 'ACTUAL'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2022-10', 'completionDateStruct': {'date': '2023-12-30', 'type': 'ESTIMATED'}, 'lastUpdateSubmitDate': '2022-10-12', 'studyFirstSubmitDate': '2021-02-25', 'studyFirstSubmitQcDate': '2021-02-25', 'lastUpdatePostDateStruct': {'date': '2022-10-13', 'type': 'ACTUAL'}, 'studyFirstPostDateStruct': {'date': '2021-03-01', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2023-12-30', 'type': 'ESTIMATED'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Comparison of toric IOL rotation between both groups (mean ≠ SD)', 'timeFrame': '1 Year', 'description': 'Aim is to see if the lying down after the operation lowers the risk of toric IOL rotation compared to sitting down'}]}, 'oversightModule': {'isFdaRegulatedDrug': False, 'isFdaRegulatedDevice': False}, 'conditionsModule': {'conditions': ['Astigmatism']}, 'descriptionModule': {'briefSummary': 'To assess the rotation stability of toric intraocular lenses between sitting or routine settings (sitting, going around) after cataract operation.', 'detailedDescription': 'To assess the rotation stability of toric intraocular lenses between sitting or routine settings (sitting, going around) after cataract operation.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'minimumAge': '21 Years', 'healthyVolunteers': True, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* Cataract\n* Age 21 and older\n* Regular corneal astigmatism ≥ 1.5 D\n* written informed consent prior to surgery\n\nExclusion Criteria:\n\n* Relevant other ophthalmic diseases such as: pseudoexfoliation, traumatic cataract corneal scars, and other co-morbidity that could affect capsule bag stability ( e.g. Marfan syndrome)\n* High myopia (\\> 29 mm AL)\n* Irregular corneal astigmatism on corneal topography\n* In case of pregnancy (pregnancy test will be taken preoperatively in women of reproductive age)'}, 'identificationModule': {'nctId': 'NCT04776057', 'briefTitle': 'Rotation Stability of Toric Intraocularlens (IOL) Compared Sitting Against Lying After Cataract Operation', 'organization': {'class': 'OTHER', 'fullName': 'Vienna Institute for Research in Ocular Surgery'}, 'officialTitle': 'Rotation Stability of Toric Intraocularlens (IOL) Compared Sitting Against Lying After Cataract Operation', 'orgStudyIdInfo': {'id': 'EK 20-302-1220'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'OTHER', 'label': 'lying', 'description': 'after cataract lying for 1 hour', 'interventionNames': ['Other: catarct surgery with toric intra ocular lenses']}, {'type': 'OTHER', 'label': 'sitting, walkin', 'description': 'after cataract sitting or walking for 1 hour', 'interventionNames': ['Other: catarct surgery with toric intra ocular lenses']}], 'interventions': [{'name': 'catarct surgery with toric intra ocular lenses', 'type': 'OTHER', 'description': 'rotation stability of toric intraocular lenses between sitting or routine settings (sitting, going around) after cataract operation', 'armGroupLabels': ['lying', 'sitting, walkin']}]}, 'contactsLocationsModule': {'locations': [{'zip': '1140', 'city': 'Vienna', 'status': 'RECRUITING', 'country': 'Austria', 'contacts': [{'name': 'Oliver Findl, Prof. MD', 'role': 'CONTACT', 'email': 'office@viros.at', 'phone': '+43 1 91021 57564'}], 'facility': 'Hanusch Hospital, Department of Ophthalmology', 'geoPoint': {'lat': 48.20849, 'lon': 16.37208}}], 'centralContacts': [{'name': 'Julius Hienert, MD', 'role': 'CONTACT', 'email': 'j.hienert@viros.at', 'phone': '+436646415113'}]}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Prim. Prof. Dr. Oliver Findl, MBA', 'class': 'OTHER'}, 'responsibleParty': {'type': 'SPONSOR_INVESTIGATOR', 'investigatorTitle': 'Prof Oliver Findl', 'investigatorFullName': 'Prim. Prof. Dr. Oliver Findl, MBA', 'investigatorAffiliation': 'Vienna Institute for Research in Ocular Surgery'}}}}