Ignite Creation Date:
2025-12-25 @ 12:19 AM
Ignite Modification Date:
2025-12-25 @ 10:22 PM
Study NCT ID:
NCT04323358
Status:
UNKNOWN
Last Update Posted:
2020-03-26
First Post:
2020-03-17
Is NOT Gene Therapy:
False
Has Adverse Events:
False
Brief Title:
Agreement and Accuracy of Different Devices for Biometry Measurements in Patients With Cataract
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'conditionBrowseModule': {'meshes': [{'id': 'D002386', 'term': 'Cataract'}, {'id': 'D003316', 'term': 'Corneal Diseases'}], 'ancestors': [{'id': 'D007905', 'term': 'Lens Diseases'}, {'id': 'D005128', 'term': 'Eye Diseases'}]}}, 'protocolSection': {'designModule': {'phases': ['NA'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'RANDOMIZED', 'maskingInfo': {'masking': 'QUADRUPLE', 'whoMasked': ['PARTICIPANT', 'CARE_PROVIDER', 'INVESTIGATOR', 'OUTCOMES_ASSESSOR'], 'maskingDescription': 'Which eye as well as the order of devices and observer will be randomized. Randomization information will be put in a sealed envelope on screening date and opened right before measurements start.'}, 'primaryPurpose': 'DIAGNOSTIC', 'interventionModel': 'SINGLE_GROUP'}, 'enrollmentInfo': {'type': 'ESTIMATED', 'count': 50}}, 'statusModule': {'overallStatus': 'UNKNOWN', 'lastKnownStatus': 'RECRUITING', 'startDateStruct': {'date': '2020-03-05', 'type': 'ACTUAL'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2020-03', 'completionDateStruct': {'date': '2020-07-30', 'type': 'ESTIMATED'}, 'lastUpdateSubmitDate': '2020-03-24', 'studyFirstSubmitDate': '2020-03-17', 'studyFirstSubmitQcDate': '2020-03-24', 'lastUpdatePostDateStruct': {'date': '2020-03-26', 'type': 'ACTUAL'}, 'studyFirstPostDateStruct': {'date': '2020-03-26', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2020-07-30', 'type': 'ESTIMATED'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Agreement of the four devices measuring mean keratometry value.', 'timeFrame': '1 year', 'description': 'The measured K-Value of each device and the k-values within one device will be compared'}], 'secondaryOutcomes': [{'measure': 'Agreement of the four devices measuring mean steep keratometry value.', 'timeFrame': '1 year', 'description': 'The measured steep K-Value of each device and the steep k-values within one device will be compared'}, {'measure': 'Agreement of the four devices measuring mean flat keratometry value.', 'timeFrame': '1 year', 'description': 'The measured flat K-Value of each device and the flat k-values within one device will be compared'}, {'measure': 'Agreement of the four devices measuring mean true keratometry value.', 'timeFrame': '1 year', 'description': 'The measured true K-Value of each device and the true k-values within one device will be compared'}, {'measure': 'Agreement of the devices measuring mean axial length', 'timeFrame': '1 year', 'description': 'The measured axial length of each device and the axial length within one device will be compared'}, {'measure': 'Agreement of the devices measuring mean lens thickness', 'timeFrame': '1 year', 'description': 'The measured lens thickness of each device and the measured lens thickness within one device will be compared'}, {'measure': 'Agreement of the devices measuring mean white-to-white measurement', 'timeFrame': '1 year', 'description': 'The measured white-to-white distance of each device and the measured white-to-white distance within one device will be compared'}]}, 'oversightModule': {'oversightHasDmc': True, 'isFdaRegulatedDrug': False, 'isFdaRegulatedDevice': False}, 'conditionsModule': {'conditions': ['Cataract', 'Cornea', 'Surgery']}, 'descriptionModule': {'briefSummary': 'The rationale of this study is to compare repeatability, reproducibility and agreement of three different AS-OCT devices and Pentacam.\n\nThe investigational devices are approved biometry and keratometry devices to perform biometric/keratometric measurements preoperatively before cataract surgery. The measurements are used to calculate the needed IOL power.\n\nMeasurements with all four devices will be performed 3 times consecutively by two trained observer. The order of the observer, the order of devices as well as the eye (left/right) is randomized.\n\nExaminations will be implemented in accordance with the approved investigational plan on subjects and includes: repeated biometry/keratometry with four different devices', 'detailedDescription': 'The rationale of this study is to compare repeatability, reproducibility and agreement of both, AS-OCT(s) and Pentacam. In our department three different AS-OCT devices and a HR Scheimpflug imaging device are currently in use for clinical routine to measure the cornea. Among refractive and anterior segment surgeons, there is no preferred and accepted method for accurate measurements of the corneal curvature. The four diagnostic tools are based on different technical and physical imaging principles and to date only limited information on their comparability exist. One advantage of ASOCT represents faster imaging speed when compared to Scheimpflug imaging. Thus, imaging misalignment, segmentation errors and defocus aberration can most likely be avoided by AS-OCT. Chen et al demonstrated that HR Scheimpflug imaging measurements of CCT were systematically higher than the measurements provided by FD AS-OCT. Further, repeatability, reproducibility and agreement of AS-OCT and Scheimpflug imaging device will be assessed during follow-up.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'maximumAge': '95 Years', 'minimumAge': '40 Years', 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* Age-related cataract\n* Age 40 and older (females of childbearing age will be interviewed if pregnancy is possible)\n\nExclusion Criteria:\n\n* Contact lens wear within 5 days\n* Pathologic changes of the cornea, eye lid or conjunctiva on slit- lamp examination\n* History of corneal ocular surgery\n* Microphthalmus\n* Recurrent intraocular inflammation of unknown etiology\n* Blind fellow eye\n* Uncontrolled systemic or ocular disease'}, 'identificationModule': {'nctId': 'NCT04323358', 'acronym': 'Comparison', 'briefTitle': 'Agreement and Accuracy of Different Devices for Biometry Measurements in Patients With Cataract', 'organization': {'class': 'OTHER', 'fullName': 'Medical University of Vienna'}, 'officialTitle': 'Agreement and Accuracy of Different Devices for Biometry Measurements in Patients With Cataract', 'orgStudyIdInfo': {'id': '1845/2019'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'ACTIVE_COMPARATOR', 'label': 'IOL Master® 700', 'description': 'Biometry will be performed three times consecutively.', 'interventionNames': ['Diagnostic Test: Biometry', 'Diagnostic Test: Keratometry']}, {'type': 'ACTIVE_COMPARATOR', 'label': 'Pentacam®', 'description': 'Keratometry will be performed three times consecutively.', 'interventionNames': ['Diagnostic Test: Keratometry']}, {'type': 'ACTIVE_COMPARATOR', 'label': 'Casia II®', 'description': 'Keratometry will be performed three times consecutively.', 'interventionNames': ['Diagnostic Test: Keratometry']}, {'type': 'ACTIVE_COMPARATOR', 'label': 'Spectralis Anterion®', 'description': 'Biometry will be performed three times consecutively.', 'interventionNames': ['Diagnostic Test: Biometry', 'Diagnostic Test: Keratometry']}], 'interventions': [{'name': 'Biometry', 'type': 'DIAGNOSTIC_TEST', 'description': 'Patients will be asked to place the chin in position and open their eyes wide. In between measurements, the patient will be arranged so his eyes are in one horizontal line and each time before measurement the patient will be asked to blink several times.', 'armGroupLabels': ['IOL Master® 700', 'Spectralis Anterion®']}, {'name': 'Keratometry', 'type': 'DIAGNOSTIC_TEST', 'description': 'Patients will be asked to place the chin in position and open their eyes wide. In between measurements, the patient will be arranged so his eyes are in one horizontal line and each time before measurement the patient will be asked to blink several times.', 'armGroupLabels': ['Casia II®', 'IOL Master® 700', 'Pentacam®', 'Spectralis Anterion®']}]}, 'contactsLocationsModule': {'locations': [{'zip': '1090', 'city': 'Vienna', 'status': 'RECRUITING', 'country': 'Austria', 'contacts': [{'name': 'Rupert Menapace, Prof.', 'role': 'CONTACT', 'email': 'rupert.menapace@meduniwien.ac.at', 'phone': '014040066300'}, {'name': 'Christina Leydolt, MD', 'role': 'CONTACT', 'email': 'christina.leydolt@meduniwien.ac.at', 'phone': '01 40400', 'phoneExt': '79480'}], 'facility': 'Medical University of Vienna Allgemeines Krankenhaus', 'geoPoint': {'lat': 48.20849, 'lon': 16.37208}}], 'centralContacts': [{'name': 'Veronika Röggla, MD', 'role': 'CONTACT', 'email': 'veronika.roeggla@meduniwien.ac.at', 'phone': '01 40400', 'phoneExt': '79450'}, {'name': 'Christina Leydolt, MD', 'role': 'CONTACT', 'email': 'christina.leydolt@meduniwien.ac.at', 'phone': '01 40400', 'phoneExt': '79480'}], 'overallOfficials': [{'name': 'Rupert Menapace, MD', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': 'Medical University of Vienna'}]}, 'ipdSharingStatementModule': {'ipdSharing': 'NO'}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Medical University of Vienna', 'class': 'OTHER'}, 'responsibleParty': {'type': 'PRINCIPAL_INVESTIGATOR', 'investigatorTitle': 'Principal Investigator', 'investigatorFullName': 'Rupert Menapace', 'investigatorAffiliation': 'Medical University of Vienna'}}}}