Ocular Surface DiseaseNCT02999035
Validation of a Newly Developed Liquid Jet Aesthesiometer
An observational study of Ocular Surface Disease, run by University of Applied Sciences and Arts Northwestern Switzerland.
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… Read more about this study
- Who is it for?
- Ages 18 to 65 yearsHealthy volunteers can take part
- Conditions the study is for
- Ocular Surface Disease
- How many people
- 60 participants
- Where
- No sites listed yet
- Study dates
- Jan 2017to Jun 2017
- Phase
- Observational
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 65 years
- All sexes
- Healthy volunteers accepted
- Adult, Older adult
Study population: 30 healthy subjects within age range of 18-30 years 30 healthy subjects within age range of 50-65 years
Who may be able to join
- Ocular surface index score < 13.0
Who cannot join
- 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.
About this study
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.
Read the 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
- Keywords
- ocular surface sensitivity
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
| Study group | Role | What they receive |
|---|---|---|
| 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 being measured
The primary outcome is the main question the study is designed to answer.
Correlation with air jet aesthesiometry
correlation between corneal sensitivity measurements between liquid jet and air jet aesthesiometry
Measured: two measurements / repeated measures within one month
Secondary outcomes (1)
repeatability of corneal sensitivity measurement with new prototype
repeatability of corneal sensitivity measurement with liquid jet aesthesiometry
Measured: two measurements / repeated measures within one month
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted21 Dec 2016 (estimated)
- Study startJan 2017
- Primary completionApr 2017
- Study completionJun 2017
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (3)Papers the sponsor has linked to this study.
- Other trials for Ocular Surface DiseaseStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Other
- Time perspective
- Other
- Enrolment
- 60 participants (estimated)
Sponsor and investigators
- Lead sponsor
- University of Applied Sciences and Arts Northwestern Switzerland
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Remo Poffa, University of Applied Sciences and Arts Northwestern Switzerland
- Investigators
- Remo Poffa, MSc., Principal investigator, University of Applied Sciences and Arts Northwestern Switzerland
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02999035
- Sponsor's protocol ID
- 2016-01867
- Other IDs
- 2016
- Status last verified
- Aug 2017
- First submitted
- 14 Dec 2016
- Last updated
- 24 Aug 2017
- Results posted
- No
- Data monitoring committee
- No
- Individual data sharing
- No: 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.
Publications
Murphy PJ, Patel S, Marshall J. A new non-contact corneal aesthesiometer (NCCA). Ophthalmic Physiol Opt. 1996 Mar;16(2):101-7.
PubMed 8762770COCHET P, BONNET R. [Corneal esthesiometry. Performance and practical importance]. Bull Soc Ophtalmol Fr. 1961 Jul-Aug;6:541-50. No abstract available. French.
PubMed 13880071Belmonte 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.
PubMed 9950612
Study at a glance
From the registry record, last updated by the sponsor on 24 Aug 2017. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Validation of a Newly Developed Liquid Jet Aesthesiometer
- ClinicalTrials.gov ID
- NCT02999035
- Acronym / sponsor ID
- 2016-01867
- Conditions
- Ocular Surface Disease
- Keywords
- ocular surface sensitivity
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 60 participants (estimated)
- Lead sponsor
- University of Applied Sciences and Arts Northwestern SwitzerlandUniversity, hospital or other
- Study start
- Jan 2017 (actual)
- Primary completion
- Apr 2017 (actual)
- Study completion
- Jun 2017 (actual)
- First posted
- 21 Dec 2016 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Observational model
- Other
- Time perspective
- Other
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| 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. |
Who may qualify
- Ages
- 18 to 65 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
- Study population
- 30 healthy subjects within age range of 18-30 years 30 healthy subjects within age range of 50-65 years
Key inclusion criteria (1 listed)
- Ocular surface index score < 13.0
Key exclusion criteria (3 listed)
- 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.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Primary outcome
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
1 secondary outcome
repeatability of corneal sensitivity measurement with new prototype
Time frame: two measurements / repeated measures within one month
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 24 Aug 2017.
- Background: PubMed 8762770Murphy PJ, Patel S, Marshall J. A new non-contact corneal aesthesiometer (NCCA). Ophthalmic Physiol Opt. 1996 Mar;16(2):101-7.
- Background: PubMed 13880071COCHET P, BONNET R. [Corneal esthesiometry. Performance and practical importance]. Bull Soc Ophtalmol Fr. 1961 Jul-Aug;6:541-50. No abstract available. French.
- Background: PubMed 9950612Belmonte 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.
- Individual participant dataSharing planned: No. 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.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Remo Poffa, MSc. principal investigator
University of Applied Sciences and Arts Northwestern Switzerland
Questions about this trial
What is this clinical trial studying?
An observational study of Ocular Surface Disease, run by University of Applied Sciences and Arts Northwestern Switzerland.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 1 inclusion and 3 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 24 Aug 2017. Status can change between updates, so confirm with the study contact before making plans.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Correlation with air jet aesthesiometry (time frame: two measurements / repeated measures within one month). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT02999035, which also lists 3 linked publications.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 24 Aug 2017.