Validation of a Newly Developed Liquid Jet Aesthesiometer

NCT ID: NCT02999035

Last Updated: 2017-08-24

Basic Information

• Recruitment Status: COMPLETED
• Total Enrollment: 60 participants
• Study Classification: OBSERVATIONAL
• Study Start Date: 2017-01-31
• Study Completion Date: 2017-06-30

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.

Conditions

Ocular Surface Disease

Study Design

• Observational Model Type: OTHER
• Study Time Perspective: OTHER

Study Groups

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.

No interventions assigned to this group

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.

• Minimum Eligible Age: 18 Years
• Maximum Eligible Age: 65 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: Yes

Sponsors

University of Applied Sciences and Arts Northwestern Switzerland

OTHER

Sponsor Role: lead

Responsible Party

Remo Poffa

Study coordinator

Responsibility Role: PRINCIPAL_INVESTIGATOR

Principal Investigators

Remo Poffa, MSc.

Role: PRINCIPAL_INVESTIGATOR

University of Applied Sciences and Arts Northwestern Switzerland

References

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

Reference Type: BACKGROUND

PMID: 8762770 (View on PubMed)

COCHET P, BONNET R. [Corneal esthesiometry. Performance and practical importance]. Bull Soc Ophtalmol Fr. 1961 Jul-Aug;6:541-50. No abstract available. French.

Reference Type: BACKGROUND

PMID: 13880071 (View on PubMed)

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.

Reference Type: BACKGROUND

PMID: 9950612 (View on PubMed)

Other Identifiers

2016-01867

Identifier Type: -

Identifier Source: org_study_id