Ignite Creation Date:
2025-12-25 @ 1:39 AM
Ignite Modification Date:
2025-12-28 @ 10:29 PM
Study NCT ID:
NCT06120894
Status:
COMPLETED
Last Update Posted:
2023-11-07
First Post:
2023-11-01
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Strip Meniscometry in Dry Eye Evaluation
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'conditionBrowseModule': {'meshes': [{'id': 'D015352', 'term': 'Dry Eye Syndromes'}], 'ancestors': [{'id': 'D007766', 'term': 'Lacrimal Apparatus Diseases'}, {'id': 'D005128', 'term': 'Eye Diseases'}]}, 'interventionBrowseModule': {'meshes': [{'id': 'D014065', 'term': 'Tonometry, Ocular'}, {'id': 'D000072776', 'term': 'Slit Lamp Microscopy'}, {'id': 'D012029', 'term': 'Refraction, Ocular'}], 'ancestors': [{'id': 'D003941', 'term': 'Diagnostic Techniques, Ophthalmological'}, {'id': 'D019937', 'term': 'Diagnostic Techniques and Procedures'}, {'id': 'D003933', 'term': 'Diagnosis'}, {'id': 'D014787', 'term': 'Vision Tests'}, {'id': 'D055620', 'term': 'Optical Phenomena'}, {'id': 'D055585', 'term': 'Physical Phenomena'}, {'id': 'D009799', 'term': 'Ocular Physiological Phenomena'}]}}, 'protocolSection': {'designModule': {'studyType': 'OBSERVATIONAL', 'designInfo': {'timePerspective': 'PROSPECTIVE', 'observationalModel': 'COHORT'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 21}, 'patientRegistry': False}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '2021-11-01', 'type': 'ACTUAL'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2023-11', 'completionDateStruct': {'date': '2022-09-30', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2023-11-01', 'studyFirstSubmitDate': '2023-11-01', 'studyFirstSubmitQcDate': '2023-11-01', 'lastUpdatePostDateStruct': {'date': '2023-11-07', 'type': 'ACTUAL'}, 'studyFirstPostDateStruct': {'date': '2023-11-07', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2022-09-30', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Change in strip meniscometry.', 'timeFrame': 'Week 1, 4, 12', 'description': 'Strip Meniscometry Tube in millimeters.'}], 'secondaryOutcomes': [{'measure': 'Change in ocular surface fluorescein staining.', 'timeFrame': 'Week 1, 4, 12', 'description': 'Oxford scheme grading with range from 0 (none staining dots) to 5 (severe dry eye).'}, {'measure': 'Change in tear film stability.', 'timeFrame': 'Week 1, 4, 12', 'description': 'Tear break up time test in seconds.'}, {'measure': 'Change in lid-parallel conjunctival folds evaluation.', 'timeFrame': 'Week 1, 4, 12', 'description': 'Lid-parallel conjunctival folds (LIPCOF) grading from 0 (no conjunctival folds) to 3 (more than two permanent and clear parallel folds (normally higher than 0.2 mm).'}, {'measure': 'Change in Ocular Surface Disease Index.', 'timeFrame': 'Week 1, 4, 12', 'description': 'Ocular Surface Disease Index (OSDI) questionnaire with range from 0 to 100 (higher score represents greater disability).'}]}, 'oversightModule': {'isFdaRegulatedDrug': False, 'isFdaRegulatedDevice': False}, 'conditionsModule': {'conditions': ['Dry Eye', 'Dry Eye Disease']}, 'descriptionModule': {'briefSummary': 'Strip meniscometry is a relatively new method for evaluating the tear meniscus. The aim of the study is to evaluate the possible effect of cataract surgery on ocular surface disease and to assess the possible benefit of strip meniscometry in the preoperative and postoperative evaluation of patients.', 'detailedDescription': "Cataract surgery is one of the most successful anterior segment surgeries and usually results in excellent postoperative visual acuity. However, some patients may experience symptoms of dry eye disease after a successful procedure, most commonly a foreign body sensation in the eye, intermittent pain, and blurred vision. These problems then interfere with normal daily activities and also reduce the patient's satisfaction with the surgery.\n\nThe new method for tear film examination Strip meniscometry (SM) appears to be a suitable alternative to the Schirmer test. SM values correlate with Oxford score (fluorescein staining), tear break up time test or measurement of meniscus height using anterior segment optical coherence tomography. It is a minimally invasive and rapid examination method that measures the volume of the aqueous component of the tear film.\n\nThe aim of this study is to evaluate the possible influence of cataract surgery on the development of iatrogenic OSD and to assess the contribution of a new diagnostic method, SM, for the evaluation of OSD before and after cataract surgery."}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'minimumAge': '18 Years', 'samplingMethod': 'PROBABILITY_SAMPLE', 'studyPopulation': 'Group will be recruited from patients who undergo cataract surgery at the Department of Ophthalmology of University Hospital Olomouc and Palacky University.', 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* age over 18 years\n* performing of pre-operative examination before cataract surgery\n* signed informed consent\n\nExclusion Criteria:\n\n* use of antiglaucoma drugs\n* chronic blepharitis\n* previous viral keratitis\n* previous keratoplasty or laser refractive surgery\n* known systemic disease causing changes on ocular surface (diabetes mellitus, connective tissue disease)\n* use of medication causing changes on ocular surface (antidepressant, beta blockers)'}, 'identificationModule': {'nctId': 'NCT06120894', 'briefTitle': 'Strip Meniscometry in Dry Eye Evaluation', 'organization': {'class': 'OTHER', 'fullName': 'University Hospital Olomouc'}, 'officialTitle': 'Strip Meniscometry in Dry Eye Evaluation in Connection With Cataract Surgery', 'orgStudyIdInfo': {'id': '24/22'}}, 'armsInterventionsModule': {'interventions': [{'name': 'Central visual acuity', 'type': 'DIAGNOSTIC_TEST', 'description': 'Measurement of central visual acuity using Snellen optotype chart.'}, {'name': 'Intraocular pressure measurement', 'type': 'DIAGNOSTIC_TEST', 'description': 'Measurement of intraocular pressure using non-contact Canon TX-20P tonometer.'}, {'name': 'Slit lamp examination', 'type': 'DIAGNOSTIC_TEST', 'description': 'Slit lamp examination of the anterior and posterior segment of the eye after pharmacological dilation of the pupil using application of short-time mydriatics (1% tropicamide and 10% phenylephrine).'}, {'name': 'Refraction and keratometry', 'type': 'DIAGNOSTIC_TEST', 'description': 'Measurement of refraction and keratometry using refractometer Nidek ARK-1a.'}, {'name': 'Optical biometry', 'type': 'DIAGNOSTIC_TEST', 'description': 'Measurement of optical biometry using biometer Argos (Barrett or SRK/T formula).'}, {'name': 'Strip meniscometry (SM)', 'type': 'DIAGNOSTIC_TEST', 'description': 'Strip meniscometry examination using strip meniscometry tube.'}, {'name': 'Lid Parallel Conjunctival Folds test (LIPCOF)', 'type': 'DIAGNOSTIC_TEST', 'description': 'Evaluation of lid parallel conjunctival folds using slit lamp examination.'}, {'name': 'Staining of the ocular surface with fluorescein', 'type': 'DIAGNOSTIC_TEST', 'description': 'Evaluation of ocular surface fluorescein staining using Oxford scheme.'}, {'name': 'Tear break up time test (TBUT)', 'type': 'DIAGNOSTIC_TEST', 'description': 'Evaluation of tear break up time using slit lamp examination.'}, {'name': 'Ocular Surface Disease Index questionnaire (OSDI)', 'type': 'OTHER', 'description': 'Evaluation of Ocular Surface Disease Index using Ocular Surface Disease Index questionnaire.'}]}, 'contactsLocationsModule': {'locations': [{'city': 'Olomouc', 'country': 'Czechia', 'facility': 'Department of Ophthalmology, University Hospital Olomouc', 'geoPoint': {'lat': 49.59552, 'lon': 17.25175}}], 'overallOfficials': [{'name': 'Marta Karhanova, MD, PhD', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': 'University Hospital Olomouc and Palacky University Olomouc'}]}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'University Hospital Olomouc', 'class': 'OTHER'}, 'collaborators': [{'name': 'Palacky University', 'class': 'OTHER'}], 'responsibleParty': {'type': 'PRINCIPAL_INVESTIGATOR', 'investigatorTitle': 'Principal Investigator', 'investigatorFullName': 'Zuzana Schreiberova', 'investigatorAffiliation': 'University Hospital Olomouc'}}}}