Ignite Creation Date:
2025-12-24 @ 5:01 PM
Ignite Modification Date:
2026-02-11 @ 4:49 AM
Study NCT ID:
NCT04580550
Status:
COMPLETED
Last Update Posted:
2020-10-08
First Post:
2020-09-30
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Axial Length Variability
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}}, 'protocolSection': {'designModule': {'phases': ['NA'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'NA', 'maskingInfo': {'masking': 'NONE'}, 'primaryPurpose': 'OTHER', 'interventionModel': 'SINGLE_GROUP'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 50}}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '2019-11-01', 'type': 'ACTUAL'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2020-10', 'completionDateStruct': {'date': '2020-03-01', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2020-10-07', 'studyFirstSubmitDate': '2020-09-30', 'studyFirstSubmitQcDate': '2020-10-07', 'lastUpdatePostDateStruct': {'date': '2020-10-08', 'type': 'ACTUAL'}, 'studyFirstPostDateStruct': {'date': '2020-10-08', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2020-03-01', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Axial length variability', 'timeFrame': '3 months', 'description': 'Evaluation of changes in axial length pre and post cataract surgery using two ss-OCT biometers'}], 'secondaryOutcomes': [{'measure': 'Lens tilt and decentration', 'timeFrame': '3 months', 'description': 'Evaluation of lens tilt and decantation using the Purkinje meter and two ss-OCT devices'}]}, 'oversightModule': {'oversightHasDmc': False, 'isFdaRegulatedDrug': False, 'isFdaRegulatedDevice': False}, 'conditionsModule': {'conditions': ['Cataract Senile']}, 'descriptionModule': {'briefSummary': 'The accuracy of IOL calculation relies on the one hand on axial length measurements and on the other hand on corneal and lens thickness measurements.\n\nAL difference in pre and postoperative measurements may be caused by changes of lens parameters.\n\nAim of this study is to evaluate the magnitude of changes in pre and postoperative measurements of AL.', 'detailedDescription': 'This is a prospective observational, controlled and unmasked study that would include patients which undergo cataract presurgical examination, after patient signed written informed consent. For each patient only one eye will be included.\n\nIn total 50 eyes of 50 patients will be include. Due to missing previous data, the sample size is an approximation.\n\nPrior to surgery, slit lamp examination and cataract grading (LOCS) is performed. Routine biometry is performed using the IOL Master 700 (Carl Zeiss Meditec AG, Jena, Germany) and Heidelberg Anterion (Heidelberg Engineering, Germany) for AL and lens measurement.\n\nAdditionally, evaluation of tilt and decentration will be performed using Purkinje meter device.\n\nFollow-up examination will be performed three months after surgery and will contain: AL and lens measurement using the two ss-OCT biometery devices, lens evaluation (tilt and decentration of the IOL) using the Purkinje meter. Refractive outcome will be evaluated by determining best-corrected visual acuity and subjective refraction.\n\nIn women of childbearing age, a pregnancy test will be performed before inclusion into the study.\n\nMain outcome variable:\n\n• Extend of AL difference between pre- and postoperative measurements in both devices\n\nAdditional outcome variables:\n\n* Agreement between the two ss-OCT devices in AL measurement\n* Evaluation of lens parameter in AL differences between pre- and postoperative measurements\n* Limit of agreement in lens tilt and decentration using two ss-OCT devices and Purkinje meter'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'maximumAge': '100 Years', 'minimumAge': '21 Years', 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* Uneventful cataract surgery\n* Age 21 and older\n* Axial length 24.00 mm and bigger\n* CT Asphina 409 M lens implanted\n\nExclusion Criteria:\n\n* Intra- or postoperative complication\n* Relevant other ophthalmic diseases that are likely to influence the measurement outcome (as: with severe corneal pathology, severe macular degeneration, severe diabetic retinopathy, dens cataract, PEX syndrome, previous ocular surgery or trauma)\n* Pregnancy'}, 'identificationModule': {'nctId': 'NCT04580550', 'briefTitle': 'Axial Length Variability', 'organization': {'class': 'OTHER', 'fullName': 'Vienna Institute for Research in Ocular Surgery'}, 'officialTitle': 'Evaluation of Axial Length Changes Between Pre and Postoperative Measurements', 'orgStudyIdInfo': {'id': 'Axial length variability'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'OTHER', 'label': 'Axial length variability', 'description': 'Aim of this study is to evaluate the magnitude of changes in pre and postoperative measurements of AL.', 'interventionNames': ['Other: Axial length variability']}], 'interventions': [{'name': 'Axial length variability', 'type': 'OTHER', 'description': 'Biometry (axial length measurement)is performed using the IOL Master 700 (Carl Zeiss Meditec AG, Jena, Germany) and Heidelberg Anterion (Heidelberg Engineering, Germany) pre and postoperatively.', 'armGroupLabels': ['Axial length variability']}]}, 'contactsLocationsModule': {'locations': [{'zip': '1140', 'city': 'Vienna', 'country': 'Austria', 'facility': 'Hanusch Hospital, Ophthalmology department', 'geoPoint': {'lat': 48.20849, 'lon': 16.37208}}]}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Vienna Institute for Research in Ocular Surgery', 'class': 'OTHER'}, 'responsibleParty': {'type': 'PRINCIPAL_INVESTIGATOR', 'investigatorTitle': 'Head of Department of Ophthalmology, Professor, Principal Investigator, MBA', 'investigatorFullName': 'Prim. Prof. Dr. Oliver Findl, MBA', 'investigatorAffiliation': 'Vienna Institute for Research in Ocular Surgery'}}}}