Ignite Creation Date:
2025-12-25 @ 1:02 AM
Ignite Modification Date:
2025-12-25 @ 11:15 PM
Study NCT ID:
NCT05672693
Status:
UNKNOWN
Last Update Posted:
2023-01-05
First Post:
2023-01-03
Is NOT Gene Therapy:
False
Has Adverse Events:
False
Brief Title:
Study on the Accuracy of Intraocular Lens Calculation Formula
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}}, 'protocolSection': {'designModule': {'studyType': 'OBSERVATIONAL', 'designInfo': {'timePerspective': 'RETROSPECTIVE', 'observationalModel': 'OTHER'}, 'enrollmentInfo': {'type': 'ESTIMATED', 'count': 500}, 'patientRegistry': False}, 'statusModule': {'overallStatus': 'UNKNOWN', 'lastKnownStatus': 'RECRUITING', 'startDateStruct': {'date': '2023-01', 'type': 'ESTIMATED'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2023-01', 'completionDateStruct': {'date': '2024-12', 'type': 'ESTIMATED'}, 'lastUpdateSubmitDate': '2023-01-03', 'studyFirstSubmitDate': '2023-01-03', 'studyFirstSubmitQcDate': '2023-01-03', 'lastUpdatePostDateStruct': {'date': '2023-01-05', 'type': 'ACTUAL'}, 'studyFirstPostDateStruct': {'date': '2023-01-05', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2024-12', 'type': 'ESTIMATED'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Mean absolute error', 'timeFrame': '1 week、1 month and 3 months postoperation', 'description': 'The Friedman test was applied to compare the median absolute error between the formulas after the zeroing of the mean numerical error.\n\nPost hoc analysis and Bonferroni correction was performed for multiple comparisons.'}], 'secondaryOutcomes': [{'measure': 'Distribution of error within ± 0.25D, ± 0.5D, ± 0.75D,and ± 1.0D', 'timeFrame': '1 week、1 month and 3 months postoperation', 'description': 'Frequency comparisons were made with the chi-square test'}]}, 'oversightModule': {'oversightHasDmc': False, 'isFdaRegulatedDrug': False, 'isFdaRegulatedDevice': False}, 'conditionsModule': {'conditions': ['the Accuracy of Intraocular Lens Calculation Formula']}, 'descriptionModule': {'briefSummary': 'In this study, we will retrospectively collect patients who have performed phacoemulsification combined with intraocular lens implantation in our hospital, collect various preoperative biometric data and postoperative refractive data of patients, conduct statistical analysis, and compare the accuracy of various IOL calculation formulas.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'maximumAge': '90 Years', 'minimumAge': '18 Years', 'samplingMethod': 'PROBABILITY_SAMPLE', 'studyPopulation': 'Patients who were previously diagnosed as "senile cataract" in the Ophthalmology Center of the Second Affiliated Hospital of Zhejiang University Medical College and who performed "phacoemulsification cataract extraction combined with intraocular lens implantation"', 'healthyVolunteers': True, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* (1) Conform to the diagnosis of cataract; (2) No complications occurred during and after operation; (3) Before and after operation, the measurement of ocular biological characteristics and refractive state can be successfully completed; (4) Patients who can be followed up regularly after operation.\n\nExclusion Criteria:\n\n* (1) Serious intraoperative or postoperative complications; (2) Complicated with other eye diseases unsuitable for intraocular lens implantation; (3) Patients with systemic diseases cannot tolerate surgery; (4) Patients with incomplete follow-up data.'}, 'identificationModule': {'nctId': 'NCT05672693', 'briefTitle': 'Study on the Accuracy of Intraocular Lens Calculation Formula', 'organization': {'class': 'OTHER', 'fullName': 'Second Affiliated Hospital, School of Medicine, Zhejiang University'}, 'officialTitle': 'Study on the Accuracy of Intraocular Lens Calculation Formula', 'orgStudyIdInfo': {'id': '2022-1059'}}, 'armsInterventionsModule': {'interventions': [{'name': 'Several Calculation Formulas of Intraocular Lens', 'type': 'OTHER', 'description': 'Comparison of the accuracy of several intraocular lens calculation formulas'}]}, 'contactsLocationsModule': {'locations': [{'zip': '310009', 'city': 'Hangzhou', 'state': 'Zhejiang', 'status': 'RECRUITING', 'country': 'China', 'contacts': [{'name': 'Wen Xu', 'role': 'CONTACT', 'email': 'xuwen2003@zju.edu.cn', 'phone': '13858185223'}], 'facility': 'Second Affiliated Hospital, Zhejiang University School of Medicine', 'geoPoint': {'lat': 30.29365, 'lon': 120.16142}}], 'centralContacts': [{'name': 'Wen Xu, PHD', 'role': 'CONTACT', 'email': 'xuwen2003@zju.edu.cn', 'phone': '13858185223'}], 'overallOfficials': [{'name': 'Wen Xu', 'role': 'STUDY_CHAIR', 'affiliation': 'Second Affiliated Hospital, Zhejiang University School of Medicine'}]}, 'ipdSharingStatementModule': {'ipdSharing': 'NO'}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Second Affiliated Hospital, School of Medicine, Zhejiang University', 'class': 'OTHER'}, 'responsibleParty': {'type': 'SPONSOR'}}}}