Ignite Creation Date:
2026-03-26 @ 3:15 PM
Ignite Modification Date:
2026-03-30 @ 3:56 AM
Study NCT ID:
NCT07453992
Status:
RECRUITING
Last Update Posted:
2026-03-06
First Post:
2026-01-18
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Postoperative Rotational Dynamics of Three Toric Intraocular Lens Designs
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2026-03-25'}, 'conditionBrowseModule': {'meshes': [{'id': 'D002386', 'term': 'Cataract'}, {'id': 'D001251', 'term': 'Astigmatism'}], 'ancestors': [{'id': 'D007905', 'term': 'Lens Diseases'}, {'id': 'D005128', 'term': 'Eye Diseases'}, {'id': 'D012030', 'term': 'Refractive Errors'}]}}, 'protocolSection': {'designModule': {'phases': ['NA'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'RANDOMIZED', 'maskingInfo': {'masking': 'NONE', 'maskingDescription': 'Outcome assessors were masked to IOL type.'}, 'primaryPurpose': 'TREATMENT', 'interventionModel': 'PARALLEL'}, 'enrollmentInfo': {'type': 'ESTIMATED', 'count': 400}}, 'statusModule': {'overallStatus': 'RECRUITING', 'startDateStruct': {'date': '2025-01-01', 'type': 'ACTUAL'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2026-01', 'completionDateStruct': {'date': '2030-12-31', 'type': 'ESTIMATED'}, 'lastUpdateSubmitDate': '2026-03-05', 'studyFirstSubmitDate': '2026-01-18', 'studyFirstSubmitQcDate': '2026-03-05', 'lastUpdatePostDateStruct': {'date': '2026-03-06', 'type': 'ACTUAL'}, 'studyFirstPostDateStruct': {'date': '2026-03-06', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2026-10-31', 'type': 'ESTIMATED'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Absolute rotational misalignment of toric intraocular lens (IOL) measured in degrees', 'timeFrame': 'Postoperative day 1, day 3, week 1, week 2, month 1, and month 3.', 'description': 'Absolute rotation of the implanted toric intraocular lens (IOL) relative to the intended axis, measured in degrees. Rotation will be quantified by registering postoperative retroillumination images to the end-of-surgery baseline frame using iris or scleral landmarks. The absolute rotation angle will be calculated for each follow-up visit.'}], 'secondaryOutcomes': [{'measure': 'Uncorrected and corrected distance visual acuity (UDVA and CDVA)', 'timeFrame': 'postoperatively on 1 day, 3 days, 1 week, 2 weeks, 1 month and 3 months', 'description': 'Uncorrected distance visual acuity (UDVA) and corrected distance visual acuity (CDVA) measured using a standardized logarithm of the minimum angle of resolution (logMAR) visual acuity chart during follow-up.'}, {'measure': 'Postoperative residual refractive astigmatism measured in diopters', 'timeFrame': 'Postoperative day 1, day 3, week 1, week 2, month 1, and month 3.', 'description': 'Residual refractive astigmatism measured by manifest refraction during follow-up visits and reported in diopters (D).'}]}, 'oversightModule': {'oversightHasDmc': False, 'isFdaRegulatedDrug': False, 'isFdaRegulatedDevice': False}, 'conditionsModule': {'keywords': ['toric intraocular lens', 'rotational stability', 'cataract', 'astigmatism'], 'conditions': ['Cataract']}, 'descriptionModule': {'briefSummary': 'This prospective comparative cohort study evaluates and compares postoperative rotational stability and time-course dynamics of three commercially available toric intraocular lenses (TECNIS Toric II \\[ZCU\\], AcrySof IQ Toric, and AT TORBI 709M) after phacoemulsification cataract surgery. Rotation is quantified by registering postoperative retroillumination photographs to the end-of-surgery baseline using iris/scleral landmarks, with follow-up at postoperative day 1, day 3, week 1, week 2, month 1, and month 3. Associations between rotational outcomes and ocular biometric parameters are analyzed using linear mixed-effects models to inform individualized IOL selection and perioperative management.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'minimumAge': '18 Years', 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* Adults aged 18 years or older with age-related cataract scheduled for phacoemulsification cataract surgery.\n* Presence of regular corneal astigmatism requiring toric intraocular lens implantation.\n* Eligible for implantation of one of the three study toric intraocular lenses based on preoperative evaluation.\n* Ability to understand the study procedures and provide written informed consent.\n\nExclusion Criteria:\n\n* History of prior ocular surgery in the study eye.\n* History of ocular trauma in the study eye.\n* Irregular corneal astigmatism or corneal pathology affecting reliable biometric measurement.\n* Intraoperative complications, including anterior capsular tear or posterior capsular rupture.\n* Inadequate pupillary dilation during surgery or postoperative examinations.\n* Evidence of zonular weakness, zonular dialysis, or lens subluxation.\n* Active ocular infection or inflammation.\n* Any other ocular or systemic condition judged by the investigator to potentially affect intraocular lens stability or study outcomes.'}, 'identificationModule': {'nctId': 'NCT07453992', 'acronym': '3 TORIC ROTATE', 'briefTitle': 'Postoperative Rotational Dynamics of Three Toric Intraocular Lens Designs', 'organization': {'class': 'OTHER', 'fullName': 'Eye & ENT Hospital of Fudan University'}, 'officialTitle': 'Postoperative Rotational Dynamics of Different Toric Intraocular Lens Designs', 'orgStudyIdInfo': {'id': 'Totic-2026-001'}, 'secondaryIdInfos': [{'id': '82171039', 'type': 'OTHER_GRANT', 'domain': 'National Natural Science Foundation of China'}]}, 'armsInterventionsModule': {'armGroups': [{'type': 'ACTIVE_COMPARATOR', 'label': 'TECNIS Toric II (ZCU)', 'description': 'Participants randomized to this arm receive implantation of the TECNIS Toric II (ZCU) intraocular lens during standard phacoemulsification cataract surgery.', 'interventionNames': ['Device: TECNIS Toric II (ZCU)']}, {'type': 'ACTIVE_COMPARATOR', 'label': 'AcrySof IQ Toric', 'description': 'Participants randomized to this arm receive implantation of the AcrySof IQ Toric intraocular lens during standard phacoemulsification cataract surgery.', 'interventionNames': ['Device: AcrySof IQ Toric']}, {'type': 'ACTIVE_COMPARATOR', 'label': 'AT TORBI 709M', 'description': 'Participants randomized to this arm receive implantation of the AT TORBI 709M intraocular lens during standard phacoemulsification cataract surgery.', 'interventionNames': ['Device: AT TORBI 709M']}], 'interventions': [{'name': 'TECNIS Toric II (ZCU)', 'type': 'DEVICE', 'description': 'Using TECNIS Toric II (ZCU) intraocular lens during standard phacoemulsification cataract surgery.', 'armGroupLabels': ['TECNIS Toric II (ZCU)']}, {'name': 'AcrySof IQ Toric', 'type': 'DEVICE', 'description': 'Using AcrySof IQ Toric intraocular lens during standard phacoemulsification cataract surgery.', 'armGroupLabels': ['AcrySof IQ Toric']}, {'name': 'AT TORBI 709M', 'type': 'DEVICE', 'description': 'Using the AT TORBI 709M intraocular lens during standard phacoemulsification cataract surgery.', 'armGroupLabels': ['AT TORBI 709M']}]}, 'contactsLocationsModule': {'locations': [{'zip': '200000', 'city': 'Shanghai', 'state': 'Shanghai Municipality', 'status': 'RECRUITING', 'country': 'China', 'contacts': [{'name': 'Xuanqiao Lin', 'role': 'CONTACT', 'email': '1532483480@qq.com', 'phone': '15088920668'}], 'facility': 'Eye and ENT hospital of Fudan University', 'geoPoint': {'lat': 31.22222, 'lon': 121.45806}}], 'centralContacts': [{'name': 'Xuanqiao Lin', 'role': 'CONTACT', 'email': '1532483480@qq.com', 'phone': '+8615088920668'}], 'overallOfficials': [{'name': 'Jin Yang', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': 'Fudan University'}]}, 'ipdSharingStatementModule': {'ipdSharing': 'NO'}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Jin Yang', 'class': 'OTHER'}, 'responsibleParty': {'type': 'SPONSOR_INVESTIGATOR', 'investigatorTitle': 'Chief Physician', 'investigatorFullName': 'Jin Yang', 'investigatorAffiliation': 'Eye & ENT Hospital of Fudan University'}}}}