Ignite Creation Date:
2025-12-24 @ 6:38 PM
Ignite Modification Date:
2026-01-01 @ 7:50 PM
Study NCT ID:
NCT06148857
Status:
UNKNOWN
Last Update Posted:
2023-11-28
First Post:
2023-11-20
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Total Corneal Astigmatism Prevalence in Cataract Patients
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, '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': {'studyType': 'OBSERVATIONAL', 'designInfo': {'timePerspective': 'RETROSPECTIVE', 'observationalModel': 'COHORT'}, 'enrollmentInfo': {'type': 'ESTIMATED', 'count': 11000}, 'patientRegistry': False}, 'statusModule': {'overallStatus': 'UNKNOWN', 'lastKnownStatus': 'NOT_YET_RECRUITING', 'startDateStruct': {'date': '2023-11', 'type': 'ESTIMATED'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2023-11', 'completionDateStruct': {'date': '2023-12', 'type': 'ESTIMATED'}, 'lastUpdateSubmitDate': '2023-11-20', 'studyFirstSubmitDate': '2023-11-20', 'studyFirstSubmitQcDate': '2023-11-20', 'lastUpdatePostDateStruct': {'date': '2023-11-28', 'type': 'ACTUAL'}, 'studyFirstPostDateStruct': {'date': '2023-11-28', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2023-11', 'type': 'ESTIMATED'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'total keratometric astigmatism', 'timeFrame': 'At Enrollment', 'description': 'Total keratometry is calculated based on the anterior and posterior corneal surface radius and CCT using the thick lens formula with the actual indices of refractions for air (1.000), cornea (1.376), and aqueous (1.336) by IOLMaster 700. Total keratometric astigmatism is taken as the TCA measured by IOLMaster 700.'}, {'measure': 'Abulafia-Koch formula total corneal astigmatism', 'timeFrame': 'At Enrollment', 'description': 'The AK formula, described by Abulafia et al, is a regression formula that calculates an estimated TCA using K astigmatism.'}, {'measure': 'Barrett toric calculator total corneal astigmatism', 'timeFrame': 'At Enrollment', 'description': 'The Barrett toric calculator uses an unpublished mathematical prediction method of TCA based on anterior corneal measurements. AL, ACD, LT, WTW, and K data by IOLMaster 700 were input into the Barrett toric calculator. The target refraction, incision surgically induced astigmatism (SIA), and incision location were all set as 0. The output net astigmatism was recorded as TCA predicted by the Barrett toric calculator.'}]}, 'oversightModule': {'isFdaRegulatedDrug': False, 'isFdaRegulatedDevice': False}, 'conditionsModule': {'keywords': ['cataract', 'astigmatism', 'prevalence'], 'conditions': ['Cataract']}, 'descriptionModule': {'briefSummary': 'The purpose of this study is to report the prevalence data for total corneal astigmatism (TCA) in cataract surgery candidates.', 'detailedDescription': 'The purpose of this retrospective study is to report the prevalence data for total corneal astigmatism (TCA) in cataract surgery candidates. Preoperative biometric data of all the patients who underwent cataract surgery in the Department of Ophthalmology, Peking University Third Hospital, from January 2019 to May 2023, were collected and analyzed. Data sets with incomplete biometric data were excluded.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['CHILD', 'ADULT', 'OLDER_ADULT'], 'samplingMethod': 'NON_PROBABILITY_SAMPLE', 'studyPopulation': 'All the patients who underwent cataract surgery in the Department of Ophthalmology, Peking University Third Hospital from January 2019 to May 2023.', 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* Patients who underwent cataract surgery in the Department of Ophthalmology, Peking University Third Hospital from January 2019 to May 2023.\n\nExclusion Criteria:\n\n* Incomplete biometric data .'}, 'identificationModule': {'nctId': 'NCT06148857', 'briefTitle': 'Total Corneal Astigmatism Prevalence in Cataract Patients', 'organization': {'class': 'OTHER', 'fullName': 'Peking University Third Hospital'}, 'officialTitle': 'Prevalence Data for Total Corneal Astigmatism in Cataract Surgery Candidates', 'orgStudyIdInfo': {'id': 'BLB2'}}, 'armsInterventionsModule': {'interventions': [{'name': 'IOLMaster 700', 'type': 'DIAGNOSTIC_TEST', 'otherNames': ['the Abulafia-Koch formula', 'the Barrett toric calculator'], 'description': 'The IOLMaster 700, one of the most commonly used optical biometers for IOL power calculation, measures the anterior corneal surface radius using a telecentric keratometry. Additionally, it employs swept-source optical coherence tomography (SS-OCT) technology to simultaneously measures the posterior cornea surface radius and central corneal thickness (CCT).\n\nThe AK formula, described by Abulafia et al., is a regression formula that calculates an estimated TCA using K astigmatism.\n\nThe Barrett toric calculator uses an unpublished mathematical prediction method of TCA based on anterior corneal measurements.'}]}, 'contactsLocationsModule': {'locations': [{'zip': '100191', 'city': 'Beijing', 'state': 'Beijing Municipality', 'country': 'China', 'facility': 'Peking University Third Hospital', 'geoPoint': {'lat': 39.9075, 'lon': 116.39723}}], 'centralContacts': [{'name': 'Hong Qi, Dr.', 'role': 'CONTACT', 'email': 'doctorgihong@163.com', 'phone': '+8613901066889', 'phoneExt': '010'}], 'overallOfficials': [{'name': 'Hong Qi, Dr.', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': 'Peking University Third Hospital'}]}, 'ipdSharingStatementModule': {'ipdSharing': 'NO'}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Peking University Third Hospital', 'class': 'OTHER'}, 'responsibleParty': {'type': 'SPONSOR'}}}}