Ignite Creation Date:
2025-12-25 @ 4:58 AM
Ignite Modification Date:
2026-03-05 @ 7:34 PM
Study NCT ID:
NCT02618018
Status:
UNKNOWN
Last Update Posted:
2015-12-01
First Post:
2015-05-20
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Clinical Evaluation of Efficacy and Stability of AT TORBI 709M 4-haptic Toric IOL in Cataract Surgery
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'conditionBrowseModule': {'meshes': [{'id': 'D064090', 'term': 'Intraocular Lymphoma'}, {'id': 'D001251', 'term': 'Astigmatism'}], 'ancestors': [{'id': 'D008223', 'term': 'Lymphoma'}, {'id': 'D009370', 'term': 'Neoplasms by Histologic Type'}, {'id': 'D009369', 'term': 'Neoplasms'}, {'id': 'D005134', 'term': 'Eye Neoplasms'}, {'id': 'D009371', 'term': 'Neoplasms by Site'}, {'id': 'D008232', 'term': 'Lymphoproliferative Disorders'}, {'id': 'D008206', 'term': 'Lymphatic Diseases'}, {'id': 'D006425', 'term': 'Hemic and Lymphatic Diseases'}, {'id': 'D007160', 'term': 'Immunoproliferative Disorders'}, {'id': 'D007154', 'term': 'Immune System Diseases'}, {'id': 'D012030', 'term': 'Refractive Errors'}, {'id': 'D005128', 'term': 'Eye Diseases'}]}}, 'protocolSection': {'designModule': {'phases': ['NA'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'NA', 'maskingInfo': {'masking': 'NONE'}, 'primaryPurpose': 'TREATMENT', 'interventionModel': 'SINGLE_GROUP'}, 'enrollmentInfo': {'type': 'ESTIMATED', 'count': 20}}, 'statusModule': {'overallStatus': 'UNKNOWN', 'lastKnownStatus': 'RECRUITING', 'startDateStruct': {'date': '2015-09'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2015-11', 'completionDateStruct': {'date': '2016-12', 'type': 'ESTIMATED'}, 'lastUpdateSubmitDate': '2015-11-25', 'studyFirstSubmitDate': '2015-05-20', 'studyFirstSubmitQcDate': '2015-11-25', 'lastUpdatePostDateStruct': {'date': '2015-12-01', 'type': 'ESTIMATED'}, 'studyFirstPostDateStruct': {'date': '2015-12-01', 'type': 'ESTIMATED'}, 'primaryCompletionDateStruct': {'date': '2016-12', 'type': 'ESTIMATED'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Visual acuity, refractive results', 'timeFrame': '3 months', 'description': 'uncorrected distance visual acuity (UCDVA) and best corrected distance visual acuity (BCDVA) measured using logarithm of the minimum angle of resolution (logMAR) refractive results measured by keratometry'}], 'secondaryOutcomes': [{'measure': 'Rotational stability', 'timeFrame': '3 months', 'description': 'Photographic evaluation of IOL rotation using slit-lamp digital photographs at each postoperative visit, and determine changes in the lens axis between visits.'}, {'measure': 'Endothelial cell count', 'timeFrame': '3 months', 'description': 'measured by specular microscopy'}, {'measure': 'Cornea thickness', 'timeFrame': '3 months', 'description': 'measured by ultrasound pachymetry'}]}, 'oversightModule': {'oversightHasDmc': True}, 'conditionsModule': {'keywords': ['astigmatism', 'toric intraocular lens'], 'conditions': ['Iol', 'Astigmatism']}, 'descriptionModule': {'briefSummary': 'The purpose of this study is to evaluate the efficacy and stability of AT TORBI 709M 4-haptic toric IOL in cataract surgery.', 'detailedDescription': "Inclusion criteria\n\n1. senile cataract\n2. patients' age of 21 years or older\n3. preoperative regular corneal astigmatism between 1.00 D and 6.00 D\n\nExclusion criteria\n\n1. pregnant, lactating women\n2. presence of other ocular diseases which affect stability of lens capsule\n\nPrimary outcome : efficacy index (visual acuity, refractive results Secondary outcome : rotational stability, endothelial cell count, cornea thickness"}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'minimumAge': '21 Years', 'healthyVolunteers': False, 'eligibilityCriteria': "Inclusion Criteria:\n\n* senile cataract\n* patients' age of 21 years or older\n* preoperative regular corneal astigmatism between 1.00 D and 6.00 D\n\nExclusion Criteria:\n\n* pregnant, lactating women\n* presence of other ocular diseases which affect stability of lens capsule"}, 'identificationModule': {'nctId': 'NCT02618018', 'briefTitle': 'Clinical Evaluation of Efficacy and Stability of AT TORBI 709M 4-haptic Toric IOL in Cataract Surgery', 'organization': {'class': 'OTHER', 'fullName': 'Seoul National University Hospital'}, 'officialTitle': 'An Investigator-Initiated Trials on the Efficacy and Stability of AT TORBI 709M 4-haptic Toric IOL in Cataract Surgery', 'orgStudyIdInfo': {'id': 'AT TORBI 709M toric IOL'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'EXPERIMENTAL', 'label': 'intraocular lens', 'description': 'AT TORBI 709M toric intraocular lens', 'interventionNames': ['Procedure: AT TORBI 709M']}], 'interventions': [{'name': 'AT TORBI 709M', 'type': 'PROCEDURE', 'description': 'Cataract surgery with AT TORBI 709M 4-haptic toric IOL', 'armGroupLabels': ['intraocular lens']}]}, 'contactsLocationsModule': {'locations': [{'zip': '110-744', 'city': 'Seoul', 'state': 'Seoul', 'status': 'RECRUITING', 'country': 'South Korea', 'contacts': [{'name': 'Mee Kum Kim, MD, PhD', 'role': 'CONTACT', 'email': 'kmk9@snu.ac.kr', 'phone': '82-10-6277-0798'}, {'name': 'Yu Jeong Kim, MD', 'role': 'CONTACT', 'email': '21cnasa@naver.com', 'phone': '82-10-2559-1377'}, {'name': 'Mee Kum Kim, MD, PhD', 'role': 'PRINCIPAL_INVESTIGATOR'}], 'facility': 'Seoul National University Hospital', 'geoPoint': {'lat': 37.566, 'lon': 126.9784}}], 'centralContacts': [{'name': 'Mee Kum Kim, MD, PhD', 'role': 'CONTACT', 'email': 'kmk9@snu.ac.kr', 'phone': '82-10-6277-0798'}, {'name': 'Yu Jeong Kim, MD', 'role': 'CONTACT', 'email': '21cnasa@naver.com', 'phone': '82-10-2559-1377'}], 'overallOfficials': [{'name': 'Mee Kum Kim, MD, PhD', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': 'Seoul National University Hospital'}]}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Seoul National University Hospital', 'class': 'OTHER'}, 'responsibleParty': {'type': 'SPONSOR'}}}}