Clinical trial NCT02999035: Validation of a Newly Developed Liquid Jet Aesthesiometer
Official title: Validation of a Newly Developed Liquid Jet Aesthesiometer
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Ocular Surface Disease
Keywords: ocular surface sensitivity
Lead sponsor: University of Applied Sciences and Arts Northwestern Switzerland
Sponsor class: OTHER
First posted: 2016-12-21
Enrollment: 60
Sex: ALL
Minimum age (years): 18
Maximum age (years): 65
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Observational model: OTHER
Time perspective: OTHER
Sampling method: NON_PROBABILITY_SAMPLE
Study population: 30 healthy subjects within age range of 18-30 years 30 healthy subjects within age range of 50-65 years

Brief summary: A new liquid jet aesthesiometer prototype was developed with the aim to measure ocular surface sensitivity by employing a liquid jet.

This 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.

Detailed description: 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.

This 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.

In this repeated measures design 60 subjects participate in corneal sensitivity measurements during two appointments with each described aesthesiometer.

Eligibility criteria: Inclusion Criteria:

* Ocular surface index score \< 13.0

Exclusion Criteria:

* systemic disease such as diabetes, diseases, injuries and operations in the anterior segment of the eye
* systemic medication and / or eyedrops / ointments that may have an influence of the tearfilm.
* contact lens wear less than 48 hours before commencement of study measurements.

Primary outcomes:
measure: Correlation with air jet aesthesiometry
timeFrame: two measurements / repeated measures within one month
Secondary outcomes:
measure: repeatability of corneal sensitivity measurement with new prototype
timeFrame: two measurements / repeated measures within one month
Other outcomes:
Locations:
Study officials:
affiliation: University of Applied Sciences and Arts Northwestern Switzerland
name: Remo Poffa, MSc.
role: PRINCIPAL_INVESTIGATOR
References:
citation: Murphy PJ, Patel S, Marshall J. A new non-contact corneal aesthesiometer (NCCA). Ophthalmic Physiol Opt. 1996 Mar;16(2):101-7.
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.
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.