Ignite Creation Date:
2025-12-24 @ 10:31 PM
Ignite Modification Date:
2026-02-10 @ 10:38 AM
Study NCT ID:
NCT02999035
Status:
COMPLETED
Last Update Posted:
2017-08-24
First Post:
2016-12-14
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Validation of a Newly Developed Liquid Jet Aesthesiometer
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}}, 'protocolSection': {'designModule': {'studyType': 'OBSERVATIONAL', 'designInfo': {'timePerspective': 'OTHER', 'observationalModel': 'OTHER'}, 'enrollmentInfo': {'type': 'ESTIMATED', 'count': 60}, 'patientRegistry': False}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '2017-01', 'type': 'ACTUAL'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2017-08', 'completionDateStruct': {'date': '2017-06', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2017-08-23', 'studyFirstSubmitDate': '2016-12-14', 'studyFirstSubmitQcDate': '2016-12-16', 'lastUpdatePostDateStruct': {'date': '2017-08-24', 'type': 'ACTUAL'}, 'studyFirstPostDateStruct': {'date': '2016-12-21', 'type': 'ESTIMATED'}, 'primaryCompletionDateStruct': {'date': '2017-04', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Correlation with air jet aesthesiometry', 'timeFrame': 'two measurements / repeated measures within one month', 'description': 'correlation between corneal sensitivity measurements between liquid jet and air jet aesthesiometry'}], 'secondaryOutcomes': [{'measure': 'repeatability of corneal sensitivity measurement with new prototype', 'timeFrame': 'two measurements / repeated measures within one month', 'description': 'repeatability of corneal sensitivity measurement with liquid jet aesthesiometry'}]}, 'oversightModule': {'oversightHasDmc': False}, 'conditionsModule': {'keywords': ['ocular surface sensitivity'], 'conditions': ['Ocular Surface Disease']}, 'referencesModule': {'references': [{'pmid': '8762770', 'type': 'BACKGROUND', 'citation': 'Murphy PJ, Patel S, Marshall J. A new non-contact corneal aesthesiometer (NCCA). Ophthalmic Physiol Opt. 1996 Mar;16(2):101-7.'}, {'pmid': '13880071', 'type': 'BACKGROUND', 'citation': 'COCHET P, BONNET R. [Corneal esthesiometry. Performance and practical importance]. Bull Soc Ophtalmol Fr. 1961 Jul-Aug;6:541-50. No abstract available. French.'}, {'pmid': '9950612', 'type': 'BACKGROUND', 'citation': 'Belmonte C, Acosta MC, Schmelz M, Gallar J. Measurement of corneal sensitivity to mechanical and chemical stimulation with a CO2 esthesiometer. Invest Ophthalmol Vis Sci. 1999 Feb;40(2):513-9.'}]}, 'descriptionModule': {'briefSummary': 'A new liquid jet aesthesiometer prototype was developed with the aim to measure ocular surface sensitivity by employing a liquid jet.\n\nThis study aims to validate this new prototype by means of correlating its measurement with a previously validated air jet aesthesiometer, the non-contact aesthesiometer (NCCA; by Murphy et al. 1996) and by exploring the repeatability of ocular surface sensitivity measurement.', 'detailedDescription': 'Currently, no aesthesiometer is available that delivers reliable and repeatable measurement of ocular surface sensitivity in a routine clinical setup. The only commercially available Cochet- Bonnet aesthesiometer uses a tactile-mechanical stimulus (the tip of a nylon thread), which can cause a microerosion when applied to the corneal surface. Additional disadvantages represent poor stimulus reproducibility, a limited stimulus bandwidth and the influence of humidity and age on the bending capibility of the nylon thread. For research purposes prototypes of non-contact air aesthesiometers (eg by Murphy et al. and Belmonte et al) are being used.\n\nThis study aims to correlate ocular surface sensitivity measurements of a newly developed prototype, the liquid jet aesthesiometer, with the non-contact air jet aesthesiometer by Murphy et al. 1996 and to explore its repeatability of measurement.\n\nIn this repeated measures design 60 subjects participate in corneal sensitivity measurements during two appointments with each described aesthesiometer.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'maximumAge': '65 Years', 'minimumAge': '18 Years', 'samplingMethod': 'NON_PROBABILITY_SAMPLE', 'studyPopulation': '30 healthy subjects within age range of 18-30 years 30 healthy subjects within age range of 50-65 years', 'healthyVolunteers': True, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* Ocular surface index score \\< 13.0\n\nExclusion Criteria:\n\n* systemic disease such as diabetes, diseases, injuries and operations in the anterior segment of the eye\n* systemic medication and / or eyedrops / ointments that may have an influence of the tearfilm.\n* contact lens wear less than 48 hours before commencement of study measurements.'}, 'identificationModule': {'nctId': 'NCT02999035', 'briefTitle': 'Validation of a Newly Developed Liquid Jet Aesthesiometer', 'organization': {'class': 'OTHER', 'fullName': 'University of Applied Sciences and Arts Northwestern Switzerland'}, 'officialTitle': 'Validation of a Newly Developed Liquid Jet Aesthesiometer', 'orgStudyIdInfo': {'id': '2016-01867'}}, 'armsInterventionsModule': {'armGroups': [{'label': 'corneal sensitivity measurement', 'description': 'Air jet aesthesiometry and liquid jet aesthesiometry:\n\nAll patients will receive the same intervention of corneal sensitivity measurement with air jet aesthesiometry and liquid jet aesthesiometry.\n\nThresholds represent the intensity of air / liquid jet that can just be perceived by the patients.'}]}, 'contactsLocationsModule': {'overallOfficials': [{'name': 'Remo Poffa, MSc.', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': 'University of Applied Sciences and Arts Northwestern Switzerland'}]}, 'ipdSharingStatementModule': {'ipdSharing': 'NO', 'description': 'individual participant data will not be made available to other researchers. The statistical analysis of the data overall will be however published, but individual participant data will not be discussed.'}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'University of Applied Sciences and Arts Northwestern Switzerland', 'class': 'OTHER'}, 'responsibleParty': {'type': 'PRINCIPAL_INVESTIGATOR', 'investigatorTitle': 'Study coordinator', 'investigatorFullName': 'Remo Poffa', 'investigatorAffiliation': 'University of Applied Sciences and Arts Northwestern Switzerland'}}}}