Validation of a Newly Developed Liquid Jet Aesthesiometer

NCT02999035 | Completed

• 1 other identifier: 2016-01867
• Study Type: observational
• Target: 60
• Locations: 0 countries
• Sites: N/A

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.

Conditions

Ocular Surface Disease

Keywords

ocular surface sensitivity

Outcome Measures

Primary Outcomes (1)

• 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 Outcomes (1)

• repeatability of corneal sensitivity measurement with new prototype

  two measurements / repeated measures within one month

Study Arms (1)

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.

Eligibility Criteria

• Age: 18 Years - 65 Years
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64), Older Adult (65+)
• 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

You may qualify if:

• Ocular surface index score \< 13.0

You may not qualify if:

• 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.

Sponsors & Collaborators

• University of Applied Sciences and Arts Northwestern Switzerland: lead

Related Publications (3)

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

  PMID: 8762770 BACKGROUND

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

  PMID: 13880071 BACKGROUND

• 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.

  PMID: 9950612 BACKGROUND

Study Officials

• Remo Poffa, MSc.

  University of Applied Sciences and Arts Northwestern Switzerland

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: observational
• Observational Model: OTHER
• Time Perspective: OTHER
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Study coordinator

Study Record Dates

• First Submitted: December 14, 2016
• First Posted: December 21, 2016
• Study Start: January 1, 2017
• Primary Completion: April 1, 2017
• Study Completion: June 1, 2017
• Last Updated: August 24, 2017

Record last verified: 2017-08

Data Sharing

• IPD Sharing: Will not share