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Completed

NCT Number: NCT02999035

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.

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Key information

Age range

18 year–65 year

Sex eligibility

All sexes

Study type

Observational

About this study

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.

Who can participate

Healthy volunteers accepted: Yes

Only the study team can determine whether someone qualifies for participation.

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.

Treatment and study plan

Primary outcomes

  1. Correlation with air jet aesthesiometry

    Time frame: two measurements / repeated measures within one month

    correlation between corneal sensitivity measurements between liquid jet and air jet aesthesiometry

Secondary outcomes

  1. repeatability of corneal sensitivity measurement with new prototype

    Time frame: two measurements / repeated measures within one month

    repeatability of corneal sensitivity measurement with liquid jet aesthesiometry

Sponsors and collaborators

Lead sponsor

University of Applied Sciences and Arts Northwestern Switzerland

Other

Registry information

Important dates

Study start
2017
Primary completion
2017
Study completion
2017
First posted
Dec 21, 2016
Registry last updated
Aug 24, 2017

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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