Ignite Creation Date:
2025-12-25 @ 1:27 AM
Ignite Modification Date:
2025-12-31 @ 4:05 PM
Study NCT ID:
NCT04384094
Status:
UNKNOWN
Last Update Posted:
2020-07-29
First Post:
2020-05-04
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Defining the Operating Parameters for a Rebound-esthesiometer
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24', 'submissionTracking': {'submissionInfos': [{'resetDate': '2021-04-23', 'releaseDate': '2021-03-29'}], 'estimatedResultsFirstSubmitDate': '2021-03-29'}}, 'conditionBrowseModule': {'meshes': [{'id': 'D003317', 'term': 'Corneal Dystrophies, Hereditary'}, {'id': 'D016849', 'term': 'Keratitis, Herpetic'}], 'ancestors': [{'id': 'D003316', 'term': 'Corneal Diseases'}, {'id': 'D005128', 'term': 'Eye Diseases'}, {'id': 'D015785', 'term': 'Eye Diseases, Hereditary'}, {'id': 'D030342', 'term': 'Genetic Diseases, Inborn'}, {'id': 'D009358', 'term': 'Congenital, Hereditary, and Neonatal Diseases and Abnormalities'}, {'id': 'D015828', 'term': 'Eye Infections, Viral'}, {'id': 'D015817', 'term': 'Eye Infections'}, {'id': 'D007239', 'term': 'Infections'}, {'id': 'D006561', 'term': 'Herpes Simplex'}, {'id': 'D006566', 'term': 'Herpesviridae Infections'}, {'id': 'D004266', 'term': 'DNA Virus Infections'}, {'id': 'D014777', 'term': 'Virus Diseases'}, {'id': 'D007634', 'term': 'Keratitis'}]}}, 'protocolSection': {'designModule': {'studyType': 'OBSERVATIONAL', 'designInfo': {'timePerspective': 'CROSS_SECTIONAL', 'observationalModel': 'CASE_ONLY'}, 'enrollmentInfo': {'type': 'ESTIMATED', 'count': 100}, 'patientRegistry': False}, 'statusModule': {'overallStatus': 'UNKNOWN', 'lastKnownStatus': 'NOT_YET_RECRUITING', 'startDateStruct': {'date': '2020-08', 'type': 'ESTIMATED'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2020-04', 'completionDateStruct': {'date': '2020-12', 'type': 'ESTIMATED'}, 'lastUpdateSubmitDate': '2020-07-28', 'studyFirstSubmitDate': '2020-05-04', 'studyFirstSubmitQcDate': '2020-05-11', 'lastUpdatePostDateStruct': {'date': '2020-07-29', 'type': 'ACTUAL'}, 'studyFirstPostDateStruct': {'date': '2020-05-12', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2020-12', 'type': 'ESTIMATED'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Rebound esthesiometer operating threshold', 'timeFrame': '2020-2021', 'description': 'Define the corneal touch sensitivity threshold using the rebound esthesiometer by varying the measurement probe impact at the moment of touch of corneal surface. The impact is varied by changing the speed (m/s) of the measurement probe and the subjective sensation of the test subject is recorded. The mass (mg) of the measurement probe is known and the impact energy is calculated.'}, {'measure': 'Rebound esthesiometer operating parameters', 'timeFrame': '2020-2021', 'description': 'Measure the correlation of corneal touch sensitivity between rebound esthesiometer and the reference instrument Cochet-Bonnet monofilament esthesiometer. With the rebound esthesiometer the impact is varied by changing the speed (m/s) of the measurement probe. The probe mass (mg) and speed (m/s) equals to the touch impact impulse which causes the touch sensation. The subjective sensation of the test subject is recorded.'}]}, 'oversightModule': {'oversightHasDmc': False, 'isFdaRegulatedDrug': False, 'isFdaRegulatedDevice': False}, 'conditionsModule': {'keywords': ['esthesiometry', 'corneal sensitivity'], 'conditions': ['Corneal Sensation Reduced', 'Corneal Dystrophy', 'Corneal Degeneration', 'Corneal Transplant Failure', 'Herpetic Keratitis']}, 'descriptionModule': {'briefSummary': 'The purpose of this study is to define the operating parameters for a new method to measure corneal sensitivity.', 'detailedDescription': 'Corneal sensitivity is the most important protective mechanism of the eye. Thus, measuring it at any given time gives important indicators of corneal physiology, especially in the diagnostics of corneal and systemic diseases (e.g. diabetes, herpes simplex and keratitis) and recovery from ocular surgery. Current commercial measurement methods are outdated, non-quantitative and uncomfortable to use, hence left unused. This results in suboptimal, even poor, diagnosis and treatment for patients.\n\nIn this study the operating parameters for a state-of-the-art esthesiometer are defined. The operating principle is based on existing rebound technology which is already approved for IOP measurement.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'minimumAge': '18 Years', 'samplingMethod': 'NON_PROBABILITY_SAMPLE', 'studyPopulation': 'Subjects entering ocular primary care examination site and patients entering eye hospital for several medical reasons.', 'healthyVolunteers': True, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* Age \\>= 18\n* Informed consent signed\n\nExclusion Criteria:\n\n* Signs of infectious or inflammatory disease of anterior eye at the time of presentation.\n* During last two weeks, any of the following events or conditions occurred or was present: inflammatory or infectious ocular condition, surgical or other intervention or therapy, other abnormal ocular event.\n* Unable to give informed consent.\n* Directly or indirectly indicated vunerability.'}, 'identificationModule': {'nctId': 'NCT04384094', 'briefTitle': 'Defining the Operating Parameters for a Rebound-esthesiometer', 'organization': {'class': 'INDUSTRY', 'fullName': 'Icare Finland Oy'}, 'officialTitle': 'Rebound Esthesiometer Phase 2 Protocol', 'orgStudyIdInfo': {'id': 'TE0X_EST_2'}}, 'armsInterventionsModule': {'armGroups': [{'label': 'Test subjects', 'description': 'Test subjects according to the inclusion / exclusion criterias.', 'interventionNames': ['Device: Esthesiometer measurement']}], 'interventions': [{'name': 'Esthesiometer measurement', 'type': 'DEVICE', 'description': 'Measuring the corneal sensitivity using rebound technology.', 'armGroupLabels': ['Test subjects']}]}, 'contactsLocationsModule': {'centralContacts': [{'name': 'Mika Salkola, M.Sc.', 'role': 'CONTACT', 'email': 'mika.salkola@icarefinland.com', 'phone': '+358400874054'}, {'name': 'Teemu Herranen, B.Sc.', 'role': 'CONTACT', 'email': 'teemu.herranen@icarefinland.com', 'phone': '+358415033680'}], 'overallOfficials': [{'name': 'Matjaz Mihelcic, Ph.D.', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': 'Optika Mesec'}]}, 'ipdSharingStatementModule': {'ipdSharing': 'NO'}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Icare Finland Oy', 'class': 'INDUSTRY'}, 'responsibleParty': {'type': 'SPONSOR'}}}, 'annotationSection': {'annotationModule': {'unpostedAnnotation': {'unpostedEvents': [{'date': '2021-03-29', 'type': 'RELEASE'}, {'date': '2021-04-23', 'type': 'RESET'}], 'unpostedResponsibleParty': 'Icare Finland Oy'}}}}