Ignite Creation Date:
2025-12-24 @ 11:30 PM
Ignite Modification Date:
2025-12-25 @ 9:18 PM
Study NCT ID:
NCT06358456
Status:
COMPLETED
Last Update Posted:
2024-04-10
First Post:
2024-03-12
Is NOT Gene Therapy:
False
Has Adverse Events:
False
Brief Title:
Influence of Artificial Tears on Keratometry and Biometry Measurements With Different Devices
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'interventionBrowseModule': {'meshes': [{'id': 'D065346', 'term': 'Lubricant Eye Drops'}], 'ancestors': [{'id': 'D009883', 'term': 'Ophthalmic Solutions'}, {'id': 'D019999', 'term': 'Pharmaceutical Solutions'}, {'id': 'D012996', 'term': 'Solutions'}, {'id': 'D004364', 'term': 'Pharmaceutical Preparations'}, {'id': 'D045506', 'term': 'Therapeutic Uses'}, {'id': 'D020228', 'term': 'Pharmacologic Actions'}, {'id': 'D020164', 'term': 'Chemical Actions and Uses'}, {'id': 'D054327', 'term': 'Lubricants'}, {'id': 'D020313', 'term': 'Specialty Uses of Chemicals'}]}}, 'protocolSection': {'designModule': {'phases': ['NA'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'RANDOMIZED', 'maskingInfo': {'masking': 'NONE', 'maskingDescription': 'The investigator and patient knew which device they were tested on'}, 'primaryPurpose': 'DIAGNOSTIC', 'interventionModel': 'PARALLEL', 'interventionModelDescription': 'one arm for each diagnostic device (three in total)'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 145}}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '2020-11-20', 'type': 'ACTUAL'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2024-04', 'completionDateStruct': {'date': '2022-04-22', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2024-04-07', 'studyFirstSubmitDate': '2024-03-12', 'studyFirstSubmitQcDate': '2024-04-07', 'lastUpdatePostDateStruct': {'date': '2024-04-10', 'type': 'ACTUAL'}, 'studyFirstPostDateStruct': {'date': '2024-04-10', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2022-04-22', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Does the application of artificial tears (Artelac EDO) alter the measurement of the anterior surface of the cornea (K mean in Diopters) using devices that either use keratometry or Scheimpflug-technology (IOL Master 700, Pentacam AXL or Galilei G6)', 'timeFrame': 'Comparison between the baseline measurements and the measurements 30 seconds after artificial tear application', 'description': 'Difference of measurement of the mean corneal refractive power in diopters before artificial tear application and after artificial tear application using one of three devices (IOL Master 700, Pentacam AXL or Galilei G6)'}], 'secondaryOutcomes': [{'measure': 'Is there any difference in anterior corneal refractive power measurements (K mean in Diopters) between the three different devices (IOL Master 700, Pentacam AXL, Galilei G6) after artificial tear (Artelac EDO) application?', 'timeFrame': 'Comparison between the baseline measurements and the measurements 30 seconds after artificial tear application', 'description': 'Difference of measurement of the mean corneal refractive power in diopters before artificial tear (Artelac EDO) application and after artificial tear application between the three devices (IOL Master 700 using Keratometry, Pentacam AXL and Galilei G6 using Schmeipflug technology)'}, {'measure': 'Does the application of artificial tears (Artelac EDO) alter the anterior astigmatism measurements (in diopters) using devices that either use keratometry or Scheimpflug-technology (IOL Master 700, Pentacam AXL or Galilei G6)', 'timeFrame': 'Comparison between the baseline measurements and the measurements 30 seconds after artificial tear application', 'description': 'Difference of measurement of the mean corneal astigmatism in diopters before artificial tear (Artelac EDO) application and after artificial tear application using three different devices (IOL Master 700, Pentacam AXL and Galilei G6)'}, {'measure': 'If there is an influence of artificial tears (Artelac EDO) on the measurement of the anterior surface of the cornea (K mean in Diopters) using the devices (IOL Master 700, Pentacam AXL or Galilei G6), how long does it last (in minutes)?', 'timeFrame': 'Comparison between the baseline measurements and the measurements up to 10 minutes after artificial tear applications', 'description': 'How long does the difference of mean corneal refractive power in diopters before artificial tear (artelac ego) application and after artificial tear application last'}]}, 'oversightModule': {'oversightHasDmc': False, 'isFdaRegulatedDrug': False, 'isFdaRegulatedDevice': False}, 'conditionsModule': {'keywords': ['artificial tears', 'keratometry', 'topography'], 'conditions': ['Healthy']}, 'referencesModule': {'references': [{'pmid': '32828877', 'type': 'BACKGROUND', 'citation': 'Roggla V, Leydolt C, Schartmuller D, Schwarzenbacher L, Meyer E, Abela-Formanek C, Menapace R. Influence of Artificial Tears on Keratometric Measurements in Cataract Patients. Am J Ophthalmol. 2021 Jan;221:1-8. doi: 10.1016/j.ajo.2020.08.024. Epub 2020 Aug 21.'}]}, 'descriptionModule': {'briefSummary': 'The goal of this clinical trial is to learn about the influence of artificial tears on measurements of healthy eyes with three different devices. The main questions it aims to answer are:\n\n* Do artificial tears alter the measurements of the corneal surface\n* Is there a difference between the devices used in this study\n\nThis is relevant because high quality measurements improve the postoperative outcome after cataract surgery.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'maximumAge': '80 Years', 'minimumAge': '18 Years', 'healthyVolunteers': True, 'eligibilityCriteria': "Inclusion Criteria:\n\n* Healthy eyes\n\nExclusion Criteria:\n\n* Any prior intraocular surgery or trauma\n* Any corneal pathology (ABMD, Fuch's, etc.)\n* Active ocular pathology (e.g., amblyopia, ARMD)\n* Contact lens wear within 2 weeks of study\n* Any corneal relaxing incisions or astigmatic keratotomy"}, 'identificationModule': {'nctId': 'NCT06358456', 'briefTitle': 'Influence of Artificial Tears on Keratometry and Biometry Measurements With Different Devices', 'organization': {'class': 'OTHER', 'fullName': 'University Clinic Frankfurt'}, 'officialTitle': 'Influence of Artificial Tears on Corneal Parameter Measurement Using Three Different Devices: Scheimpflug-, Keratometry - and Placido-technology', 'orgStudyIdInfo': {'id': '20-928'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'ACTIVE_COMPARATOR', 'label': 'IOL Master 700', 'description': 'Patients in this arm are measured twice with the IOL master 700 without intervention. After this artificial tears are applied and followed by 4 more measurements', 'interventionNames': ['Drug: Artificial tear', 'Other: No artificial tears']}, {'type': 'ACTIVE_COMPARATOR', 'label': 'Pentacam AXL', 'description': 'Patients in this arm are measured twice with the Pentacam AXL without intervention. After this artificial tears are applied and followed by 4 more measurements', 'interventionNames': ['Drug: Artificial tear', 'Other: No artificial tears']}, {'type': 'ACTIVE_COMPARATOR', 'label': 'Galilei G6', 'description': 'Patients in this arm are measured twice with the Galilei G6 without intervention. After this artificial tears are applied and followed by 4 more measurements', 'interventionNames': ['Drug: Artificial tear', 'Other: No artificial tears']}], 'interventions': [{'name': 'Artificial tear', 'type': 'DRUG', 'otherNames': ['Artelac EDO'], 'description': 'Application of low viscosity artificial tears (Artelac EDO). The active ingredient is hypromellose (1.92 mg per 0.6 ml container).', 'armGroupLabels': ['Galilei G6', 'IOL Master 700', 'Pentacam AXL']}, {'name': 'No artificial tears', 'type': 'OTHER', 'description': 'Before artificial tear application, 2 baseline measurements were taken of the cornea without any intervention', 'armGroupLabels': ['Galilei G6', 'IOL Master 700', 'Pentacam AXL']}]}, 'contactsLocationsModule': {'locations': [{'zip': '60590', 'city': 'Frankfurt am Main', 'state': 'Hesse', 'country': 'Germany', 'facility': 'Goethe University Hospital', 'geoPoint': {'lat': 50.11552, 'lon': 8.68417}}]}, 'ipdSharingStatementModule': {'ipdSharing': 'NO'}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'University Clinic Frankfurt', 'class': 'OTHER'}, 'responsibleParty': {'type': 'PRINCIPAL_INVESTIGATOR', 'investigatorTitle': 'Prof. Dr. Thomas Kohnen', 'investigatorFullName': 'Professor Dr. med. Thomas Kohnen', 'investigatorAffiliation': 'University Clinic Frankfurt'}}}}