Ignite Creation Date:
2025-12-24 @ 11:37 PM
Ignite Modification Date:
2025-12-30 @ 3:13 AM
Study NCT ID:
NCT05042856
Status:
UNKNOWN
Last Update Posted:
2021-09-21
First Post:
2021-08-22
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
To Evaluate IOL Position, Clinical Outcome of PanOptix in High Myopic Cataract Patients
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'conditionBrowseModule': {'meshes': [{'id': 'D002386', 'term': 'Cataract'}], 'ancestors': [{'id': 'D007905', 'term': 'Lens Diseases'}, {'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': 'NOT_YET_RECRUITING', 'startDateStruct': {'date': '2021-10-01', 'type': 'ESTIMATED'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2021-09', 'completionDateStruct': {'date': '2022-09-30', 'type': 'ESTIMATED'}, 'lastUpdateSubmitDate': '2021-09-18', 'studyFirstSubmitDate': '2021-08-22', 'studyFirstSubmitQcDate': '2021-09-04', 'lastUpdatePostDateStruct': {'date': '2021-09-21', 'type': 'ACTUAL'}, 'studyFirstPostDateStruct': {'date': '2021-09-13', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2022-09-30', 'type': 'ESTIMATED'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Effective Lens Position（ELP）', 'timeFrame': '3 months', 'description': 'Mean change of ELP for 3 months'}], 'secondaryOutcomes': [{'measure': 'capsule bending index（CBI）', 'timeFrame': '3months', 'description': 'Post-op 1 day，1week，1month，and 3 months monocular CBI(Swept source OCT,Casia SS-1000; Tomey)'}, {'measure': 'lOL tilt', 'timeFrame': '3 months', 'description': 'Post-op 1 day ,1 week,1 month and 3 months lOL tilt(Swept source OCT,Casia SS-1000; Tomey)'}, {'measure': 'lOL decentration', 'timeFrame': '3 months', 'description': 'Post-op 1 day ,1 week,1 month and 3 months lOL decentration(Swept source OCT,Casia SS-1000; Tomey)'}, {'measure': 'Monocular uncorrected distance visual acuity（UDVA）', 'timeFrame': '3 months', 'description': 'Pre-op and post-op 1 day,1 week,1 month and 3 months Monocular UDVA(Chinese standard logarithmic charts)'}, {'measure': 'Monocular best corrected distance visual acuity（BCDVA）(5m)', 'timeFrame': '3 months', 'description': 'Pre-op and post-op 1 day,1 week,1 month and 3 months Monocular BCDVA(5m)(Chinese standard logarithmic charts)'}, {'measure': 'Monocular uncorrected intermediate visual acuity（UIVA）', 'timeFrame': '3 months', 'description': 'Pre-op and post-op 1 day,1 week,1 month and 3 months Monocular UIVA(Chinese standard logarithmic charts)'}, {'measure': 'Monocular distance corrected intermediate visual acuity(DCIVA)(60cm)', 'timeFrame': '3 months', 'description': 'Pre-op and post-op 1 day,1 week,1 month and 3 months Monocular DCIVA(60cm)(Chinese standard logarithmic charts)'}, {'measure': 'Monocular uncorrected near visual acuity（UNVA）', 'timeFrame': '3 months', 'description': 'Pre-op and post-op 1 day,1 week,1 month and 3 months Monocular UNVA(Chinese standard logarithmic charts)'}, {'measure': 'Monocular distance corrected near visual acuity(DCNVA)(40cm)', 'timeFrame': '3 months', 'description': 'Pre-op and post-op 1 day,1 week,1 month and 3 months Monocular DCNVA(40cm)(Chinese standard logarithmic charts)'}, {'measure': 'manifest refraction', 'timeFrame': '3 months', 'description': 'Pre-op and post-op 1 day,1 week,1 month and 3 months manifest refraction'}, {'measure': 'Monocular defocus curve', 'timeFrame': '3 months', 'description': 'Post-op 1month,3 months monocular defocus curve'}, {'measure': 'modulation transfer function（MTF）', 'timeFrame': '3 months', 'description': 'Post-op 1 day,1 week,1 month and 3 months MTF(OPD-Scan III Analyzer,NIDEK CO.,LTD.,Tokyo,Japan)'}, {'measure': 'high-order aberrations（HOA）', 'timeFrame': '3 months', 'description': 'Post-op 1 day,1 week,1 month and 3 months HOA(OPD-Scan III Analyzer,NIDEK CO.,LTD.,Tokyo,Japan)'}]}, 'oversightModule': {'oversightHasDmc': False, 'isFdaRegulatedDrug': False, 'isFdaRegulatedDevice': False}, 'conditionsModule': {'keywords': ['PanOptix IOL', 'high myopic cataract patients'], 'conditions': ['Cataract', 'High Myopia']}, 'descriptionModule': {'briefSummary': 'To evaluate IOL position, clinical outcome of PanOptix in high myopic cataract patients', 'detailedDescription': 'A prospective, single center study to evaluate IOL position, clinical outcome of PanOptix in high myopic cataract patients.\n\nThe objective of this study to investigate the refractive and visual performance of PanOptix and explore their correlation with ELP change, capsular bending formation, IOL tilt/decentration in high myopic cataract patients.\n\nPanOptix IOL provides good refractive outcomes and visual quality because of few ELP change, fast capsular bending formation and few tilt and decentration in high myopic cataract patients.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'minimumAge': '18 Years', 'healthyVolunteers': False, 'eligibilityCriteria': "Inclusion Criteria:\n\n* Patients over 18 years old\n* 26 ≤Axial length\\<30mm, IOL power ≥6D (PanOptix IOL power is available +6D-+30D )\n* Eyes with corneal astigmatism less than 1.0D (IOLMaster 700, Carl Zeiss Meditec AG)\n* Eyes with pupil diameter between 3 and 5.5 mm (iTrace, Tracey Technology, Houston, Texas, USA)\n* Eyes with angle kappa and angle Alpha ≤0.50 mm (iTrace);\n* Eyes with corneal spherical aberration ≤ 0.50 (Pentacam).\n\nExclusion Criteria:\n\n* Irregular corneal astigmatism\n* Serious intraoperative complications, glaucoma, pseudoexfoliation syndrome, uveitis, macular degeneration or other retinal impairment\n* Moderate-severe dry eye, corneal scarring, amblyopia\n* Patients who can't cooperate with post-op 3 months follow-up."}, 'identificationModule': {'nctId': 'NCT05042856', 'briefTitle': 'To Evaluate IOL Position, Clinical Outcome of PanOptix in High Myopic Cataract Patients', 'organization': {'class': 'OTHER', 'fullName': 'Wenzhou Medical University'}, 'officialTitle': 'A Prospective, Single Center Study to Evaluate IOL Position, Clinical Outcome of PanOptix in High Myopic Cataract Patients', 'orgStudyIdInfo': {'id': 'ZYY-PanOptix IOL'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'EXPERIMENTAL', 'label': 'PanOptix', 'description': 'All the patients will be bilaterally implanted with PanOptix IOL，one eye will be randomized selected for monocular analysis of each patient.', 'interventionNames': ['Procedure: PanOptix IOL implantation']}], 'interventions': [{'name': 'PanOptix IOL implantation', 'type': 'PROCEDURE', 'description': 'All the patients will be bilaterally implanted with PanOptix IOL，one eye will be randomized selected for monocular analysis of each patient.', 'armGroupLabels': ['PanOptix']}]}, 'contactsLocationsModule': {'locations': [{'zip': '325027', 'city': 'Wenzhou', 'state': 'Zhejiang', 'country': 'China', 'contacts': [{'name': 'zhao yun-e', 'role': 'CONTACT', 'phone': '+86 13819707056'}], 'facility': 'Ophthalmology and Optometry Hospital', 'geoPoint': {'lat': 27.99942, 'lon': 120.66682}}], 'centralContacts': [{'name': 'yinying zhao', 'role': 'CONTACT', 'email': 'ginger146@126.com', 'phone': '+86 13957763247'}], 'overallOfficials': [{'name': 'yune zhao, MD', 'role': 'STUDY_CHAIR', 'affiliation': 'Wenzhou Medical University'}]}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Wenzhou Medical University', 'class': 'OTHER'}, 'responsibleParty': {'type': 'PRINCIPAL_INVESTIGATOR', 'investigatorTitle': 'Vice president of Eye Hospital of Wenzhou Medical University', 'investigatorFullName': 'Yune Zhao', 'investigatorAffiliation': 'Wenzhou Medical University'}}}}