Validation of a Newly Developed Liquid Jet Aesthesiometer

Ocular Surface Disease Clinical Trial

Official title:

Validation of a Newly Developed Liquid Jet Aesthesiometer

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT02999035
• Other study ID #: 2016-01867
• Status: Completed
• Phase: N/A
• First received: December 14, 2016
• Last updated: August 23, 2017
• Start date: January 2017
• Est. completion date: June 2017

Study information

• Verified date: August 2017
• Source: University of Applied Sciences and Arts Northwestern Switzerland
• Contact: n/a
• Is FDA regulated: No
• Study type: Observational

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 60
• Est. completion date: June 2017
• Est. primary completion date: April 2017
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: All
• Age group: 18 Years to 65 Years

Eligibility

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.

Related Conditions & MeSH terms

• Ocular Surface Disease

Locations

Country	Name	City	State
n/a

Sponsors (1)

Lead Sponsor	Collaborator
University of Applied Sciences and Arts Northwestern Switzerland

References & Publications (3)

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. — View Citation

COCHET P, BONNET R. [Corneal esthesiometry. Performance and practical importance]. Bull Soc Ophtalmol Fr. 1961 Jul-Aug;6:541-50. French. — View Citation

Murphy PJ, Patel S, Marshall J. A new non-contact corneal aesthesiometer (NCCA). Ophthalmic Physiol Opt. 1996 Mar;16(2):101-7. — View Citation

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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	repeatability of corneal sensitivity measurement with new prototype	repeatability of corneal sensitivity measurement with liquid jet aesthesiometry	two measurements / repeated measures within one month