Ignite Creation Date:
2025-12-24 @ 7:37 PM
Ignite Modification Date:
2025-12-28 @ 5:07 PM
Study NCT ID:
NCT04776603
Status:
COMPLETED
Last Update Posted:
2021-03-01
First Post:
2020-11-30
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
A Comparison of the Accuracy of Toric Intraocular Lens Formulas
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'conditionBrowseModule': {'meshes': [{'id': 'D001251', 'term': 'Astigmatism'}, {'id': 'D002386', 'term': 'Cataract'}], 'ancestors': [{'id': 'D012030', 'term': 'Refractive Errors'}, {'id': 'D005128', 'term': 'Eye Diseases'}, {'id': 'D007905', 'term': 'Lens Diseases'}]}}, 'protocolSection': {'designModule': {'studyType': 'OBSERVATIONAL', 'designInfo': {'timePerspective': 'RETROSPECTIVE', 'observationalModel': 'CASE_ONLY'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 172}, 'patientRegistry': False}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '2015-01', 'type': 'ACTUAL'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2021-02', 'completionDateStruct': {'date': '2020-01', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2021-02-26', 'studyFirstSubmitDate': '2020-11-30', 'studyFirstSubmitQcDate': '2021-02-26', 'lastUpdatePostDateStruct': {'date': '2021-03-01', 'type': 'ACTUAL'}, 'studyFirstPostDateStruct': {'date': '2021-03-01', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2019-12', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'A Comparison of the Accuracy of Toric Intraocular Lens Formulas', 'timeFrame': '5 years', 'description': 'percentage of eyes with a prediction error within ±0.50 diopter (D)'}]}, 'oversightModule': {'isFdaRegulatedDrug': False, 'isFdaRegulatedDevice': False}, 'conditionsModule': {'keywords': ['calculators', 'cataract', 'intraocular lens power', 'toric'], 'conditions': ['Astigmatism']}, 'referencesModule': {'references': [{'pmid': '27255241', 'type': 'BACKGROUND', 'citation': 'Abulafia A, Koch DD, Wang L, Hill WE, Assia EI, Franchina M, Barrett GD. New regression formula for toric intraocular lens calculations. J Cataract Refract Surg. 2016 May;42(5):663-71. doi: 10.1016/j.jcrs.2016.02.038.'}, {'pmid': '32371252', 'type': 'RESULT', 'citation': 'Kane JX, Connell B. A Comparison of the Accuracy of 6 Modern Toric Intraocular Lens Formulas. Ophthalmology. 2020 Nov;127(11):1472-1486. doi: 10.1016/j.ophtha.2020.04.039. Epub 2020 May 1.'}]}, 'descriptionModule': {'briefSummary': 'To compare the accuracy of the Abulafia-Koch, the Barrett, the Barrett Post ,the EVO , the new Holladay with total surgical-induced astigmatism, the Kane and and the Næser-Savini toric intraocular lens (IOL) power formulas using a large database of toric IOL refractive outcomes', 'detailedDescription': 'To compare the accuracy of the Abulafia-Koch, the Barrett, the Barrett Post ,the EVO , the new Holladay with total surgical-induced astigmatism, the Kane and and the Næser-Savini toric intraocular lens (IOL) power formulas using a large database of toric IOL refractive outcomes.Retrospective consecutive case series.One hundred seventy-two eyes of 172 patients who had a toric IOL inserted during surgery.One eligible eye from patients having uncomplicated cataract surgery with insertion of an Alcon SN6AT(2-9) IOL (Alcon Laboratories, Inc, Fort Worth, TX) from 1 surgeon were included in the study. pre-operative were measured using either the IOLMaster 500 or 700 (Carl Zeiss Meditec AG, Jena, Germany). Using vector calculation, the predicted postoperative refractive astigmatism was calculated for each formula. This was compared with the actual postoperative refractive astigmatism to give the prediction error.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'maximumAge': '90 Years', 'minimumAge': '21 Years', 'samplingMethod': 'PROBABILITY_SAMPLE', 'studyPopulation': 'Patients who underwent cataract surgery at Eye hospital of Wenzhou Medical University,with insertion of the Alcon SN6AT(2-9) IOL(Alcon Laboratories, Inc, Fort Worth, TX)', 'eligibilityCriteria': 'Inclusion Criteria:\n\n* uncomplicated cataract surgery with a temporal clear corneal incision,with preoperative biometry using either the IOLMaster 500 (softwareversions 5.5 and 7.7) or 700 (software version 1.50; Carl Zeiss Meditec AG, Jena, Germany)\n* subjective manifest refraction performed by any of the orthoptists in the practice and measurement of the actual postoperative axis of the IOL alignment performed in the same visit an average of 1 or 3months after surgery.\n\nExclusion Criteria:\n\n* any corneal disease (keratoconus, other ectasia, pterygium, or previous trauma);\n* previous ophthalmic operations, including laser vision correction, vitrectomy, pterygium surgery, penetrating glaucoma surgery, or scleral buckling procedures\n* intraoperative or postoperative complications\n* postoperative corrected distance visual acuity worse than 6/9'}, 'identificationModule': {'nctId': 'NCT04776603', 'briefTitle': 'A Comparison of the Accuracy of Toric Intraocular Lens Formulas', 'organization': {'class': 'OTHER', 'fullName': 'Wenzhou Medical University'}, 'officialTitle': 'A Comparison of the Accuracy of Many Different Toric Intraocular Lens Formulas', 'orgStudyIdInfo': {'id': 'Toric-CPJ'}}, 'armsInterventionsModule': {'armGroups': [{'label': 'Group 1', 'description': 'group 1 includes patients who axial length(AL)\\<26mm'}, {'label': 'Group 2', 'description': 'group 2 includes patients who axial length（AL）≥26mm'}]}, 'contactsLocationsModule': {'locations': [{'city': 'Zhejiang', 'country': 'China', 'geoPoint': {'lat': 25.3238, 'lon': 105.583}}]}, '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'}}}}