Validation of a Newly Developed Liquid Jet Aesthesiometer

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.

Study Overview

• Status: Completed
• Conditions: Ocular Surface Disease

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.

• Study Type: Observational
• Enrollment (Anticipated): 60

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years to 65 years (ADULT, OLDER_ADULT)
• Accepts Healthy Volunteers: Yes
• Genders Eligible for Study: All

• 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

Description

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.

Study Plan

How is the study designed?

Number of groups / cohorts

1

Cohorts and Interventions

Group / Cohort
corneal sensitivity measurement; Air jet aesthesiometry and liquid jet aesthesiometry: All patients will receive the same intervention of corneal sensitivity measurement with air jet aesthesiometry and liquid jet aesthesiometry. Thresholds represent the intensity of air / liquid jet that can just be perceived by the patients.

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Correlation with air jet aesthesiometry	correlation between corneal sensitivity measurements between liquid jet and air jet aesthesiometry	two measurements / repeated measures within one month

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
repeatability of corneal sensitivity measurement with new prototype	repeatability of corneal sensitivity measurement with liquid jet aesthesiometry	two measurements / repeated measures within one month

Collaborators and Investigators

• Sponsor: University of Applied Sciences and Arts Northwestern Switzerland
• Investigators: Principal Investigator: Remo Poffa, MSc., University of Applied Sciences and Arts Northwestern Switzerland

Publications and helpful links

General Publications

• Murphy PJ, Patel S, Marshall J. A new non-contact corneal aesthesiometer (NCCA). Ophthalmic Physiol Opt. 1996 Mar;16(2):101-7.
• COCHET P, BONNET R. [Corneal esthesiometry. Performance and practical importance]. Bull Soc Ophtalmol Fr. 1961 Jul-Aug;6:541-50. No abstract available. French.
• 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.

Study record dates

Study Major Dates

• Study Start (ACTUAL): January 1, 2017
• Primary Completion (ACTUAL): April 1, 2017
• Study Completion (ACTUAL): June 1, 2017

Study Registration Dates

• First Submitted: December 14, 2016
• First Submitted That Met QC Criteria: December 16, 2016
• First Posted (ESTIMATE): December 21, 2016

Study Record Updates

• Last Update Posted (ACTUAL): August 24, 2017
• Last Update Submitted That Met QC Criteria: August 23, 2017
• Last Verified: August 1, 2017

More Information

Terms related to this study

• Keywords: ocular surface sensitivity
• Other Study ID Numbers: 2016-01867

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO
• IPD Plan 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.