Cornea; Sense LossNCT04045509
Investigation in Corneal Sensation
A study testing Liquid Jet Esthesiometer Prototype, Tactile Esthesiometer Prototype and Cochet Bonnet esthesiometer in people with Cornea; Sense Loss, run by Daniela Nosch at 1 site in Switzerland.
Trial summary
The aim is to find out more about how corneal sensory fibres react to different types of stimuli (liquid / tactile / nylon thread) and how this can be consciously perceived by the individual. Read more about this study
- Who is it for?
- Ages 18 to 70 yearsHealthy volunteers can take part
- Conditions the study is for
- Cornea; Sense Loss
- What is being tested?
- Liquid Jet Esthesiometer Prototype, Tactile Esthesiometer Prototype and Cochet Bonnet esthesiometer
- Type of treatment
- Medical device
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 90 participants
- Where
- 1 siteSwitzerland
- Study dates
- 1 Sep 2019to 30 Nov 2019
- Phase
- Interventional
- 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 70 years
- All sexes
- Healthy volunteers accepted
- Adult, Older adult
Who may be able to join
- Group 'young age': 18 - 30 years of age; healthy eyes with Ocular Surface Disease Index Score </= 13
- Group 'advanced age': 50 - 70 years of age; healthy eyes with Ocular Surface Disease Index Score </= 13
Who cannot join
- Systemic disease that may affect ocular health, such as diabetes
- Injury and history of operations on the anterior segment of the eye
- regular application of systemic or ocular medication known to affect the tear film, specifically on the day of measurement
- rigid gas permeable contact lens wear
- soft contact lens wear less than 48 hours before study visit
Trial locations and contacts
1 site in 1 country.
Switzerland1 site
Institute of Optometry, FHNW
Olten, Canton of Solothurn, 4600
About this study
Official title: Investigation in Variability and Repeatability of Corneal Sensation in a Normal Population
The aim is to find out more about how corneal sensory fibres react to different types of stimuli (liquid / tactile / nylon thread) and how this can be consciously perceived by the individual. Is it possible to generate a stimulus that delivers a repeatable and reliable response within a useful stimulus force range which allows an interpretation / evaluation of normal / expected activity of superficial nerve fibres in the cornea? The study group will be divided into two age groups, as sensitivity changes are thought to occur in dependence of age. In vivo confocal microscopy has shown that the density of corneal nerve fibres in the sub-basal nerve plexus decreases with age, which consequently would suggest that sensitivity should also decrease. A very interesting research question is to find out, if such sensitivity differences can be detected with the nature of the stimuli applied in this study.
Read the detailed description
The aim of this study is to gain more physiological knowledge about ocular surface sensation (corneal sensitivity), with application of three different concepts employing different types of stimuli for triggering a response from the pain sensitive nerve endings in the superficial cornea: 1) liquid jet (consisting of isotonic saline solution; prototype), 2) tactile stimulus (round plastic nozzle, prototype) 3) commercially available Cochet Bonnet esthesiometer (nylon thread). Measurements will be carried out on healthy eyes of subjects in two different age groups.
Current knowledge about human corneal sensitivity is limited, as applied methods for ocular surface sensation measurement are limited with regards to reproducibility / accuracy.
Corneal sensitivity represents a neurological response from the free nerve endings within the epithelium. They are sensitive to mechanical, electrical, chemical or thermal stimuli and hence have a protective function for the cornea. Corneal nerves play an important role in cell growth and proliferation of epithelial cells, wound healing and repair. In experimental studies, corneal denervation has been reported to result in epithelial changes: increased permeability, decreased proliferation, changed appearance and delayed wound healing. Therefore, intact corneal innervation is required to maintain the integrity of a normal corneal epithelium. Corneal sensory nerves are believed to play an important role in maintaining the resting tear flow, as their afferent impulses from the ocular surface lead to a reflex response, best described by the lacrimal functional unit: an integrated system comprising the ocular surface tissues (cornea, corneal limbus, conjunctiva, conjunctival blood vessels, and eyelids), the tear secreting components (main and accessory lacrimal glands, meibomian glands, conjunctival goblet, and epithelial cells), and the sensory and motor nerves that connect them.
Current knowledge about ocular surface sensitivity is insufficient, as currently available measurement possibilities lack repeatability and accuracy. Before a new instrument can be developed, more research is required, in order to find a suitable concept for precise sensitivity measurement. For this purpose, two new different concepts with different / new stimulus types will be applied repeatably on healthy eyes in this study. The aim is to find out more about how corneal sensory fibres react to different types of stimuli (liquid / tactile / nylon thread) and how this can be consciously perceived by the individual. Is it possible to generate a stimulus that delivers a repeatable and reliable response within a useful stimulus force range which allows an interpretation / evaluation of normal / expected activity of superficial nerve fibres in the cornea? The study group will be divided into two age groups, as sensitivity changes are thought to occur in dependence of age. In vivo confocal microscopy has shown that the density of corneal nerve fibres in the sub-basal nerve plexus decreases with age, which consequently would suggest that sensitivity should also decrease. A very interesting research question is to find out, if such sensitivity differences can be detected with the nature of the stimuli applied in this study.
- Conditions
- Cornea; Sense Loss
- Being tested
- Liquid Jet Esthesiometer Prototype, Tactile Esthesiometer Prototype, Cochet Bonnet esthesiometer
- Keywords
- corneal sensation, subbasal nerve plexus
- Medical subject headings
- Corneal Diseases
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Liquid Jet Esthesiometer PrototypeDevice
Balanced salt solution with a pH value similar to the tear film uesd as a liquid jet stimulus for corneal sensation threshold measurement
Tactile Esthesiometer PrototypeDevice
A round plastic nozzle (1.8mm diameter) used as a stimulus for corneal sensation threshold measurement
Cochet Bonnet esthesiometerDevice
A nylon thread (0.12mm diameter) used as a stimulus for corneal sensation threshold measurement
| Study group | Role | What they receive |
|---|---|---|
| Group 'young age' | Other | Group 'young age': 18 - 30 years of age; healthy eyes Receives: Device: Liquid Jet Esthesiometer Prototype; Device: Tactile Esthesiometer Prototype; Device: Cochet Bonnet esthesiometer |
| Group 'advanced age' | Other | Group 'advanced age': 50 - 70 years of age; healthy eyes Receives: Device: Liquid Jet Esthesiometer Prototype; Device: Tactile Esthesiometer Prototype; Device: Cochet Bonnet esthesiometer |
What is being measured
The primary outcome is the main question the study is designed to answer.
Repeatability of mechanical corneal sensation thresholds with the Cochet Bonnet esthesiometer
Evaluation of repeatability of mechanical corneal sensation thresholds for the measurement with the Cochet Bonnet instrument (in mN): the corneal sensation thresholds will be obtained with the double staircase method (with forced choice) and the stimulus represents a nylon thread, whereby its force is proportional to the length of the nylon thread applied to the corneal surface.
Measured: two weeks
Repeatability of mechanical corneal sensation thresholds with the liquid jet protoype esthesiometer
Evaluation of repeatability of mechanical corneal sensation thresholds for the measurement with the liquid jet esthesiometer prototype instrument (in mbar): the corneal sensation thresholds will be obtained with the double staircase method (with forced choice) and the stimulus represents a liquid jet (consisting of isotonic saline solution).
Measured: two weeks
Repeatability of mechanical corneal sensation thresholds with the tactile prototype esthesiometer
Evaluation of variability / repeatability of mechanical corneal sensation thresholds for the measurement with the tactile esthesiometer prototype instrument (in mN): the corneal sensation thresholds will be obtained with the double staircase method (with forced choice) and the stimulus represents a small, round plastic ball.
Measured: two weeks
Secondary outcomes (9)
Correlation between corneal sensation thresholds with the Cochet Bonnet esthesiometer
Correlation between corneal sensitivity thresholds (in mN) obtained with the Cochet Bonnet esthesiometer
Measured: one day
Correlation between corneal sensation thresholds with the liquid jet prototype esthesiometer
Correlation between corneal sensitivity thresholds (in mbar) obtained with the liquid jet prototype esthesiometer
Measured: one day
Correlation between corneal sensation thresholds with the tactile prototype esthesiometer
Correlation between corneal sensitivity thresholds (in mN) obtained with the tactile prototype esthesiometer
Measured: one day
Correlation between corneal sensitivity thresholds, obtained with the Cochet Bonnet esthesiometer, and general pain perception
Correlation between corneal sensitivity thresholds obtained with the Cochet Bonnet esthesiometer and general pain perception, obtained with three different stimulus types, for each of the two different age groups recruited.
Measured: within two weeks
Correlation between corneal sensitivity thresholds, obtained with the liquid jet prototype esthesiometer, and general pain perception
Correlation between corneal sensitivity thresholds, obtained with the liquid jet prototype esthesiometer, and general pain perception
Measured: within two weeks
Correlation between corneal sensitivity thresholds, obtained with the tactile prototype esthesiometer, and general pain perception
Correlation between corneal sensitivity thresholds, obtained with the tactile prototype esthesiometer, and general pain perception
Measured: within two weeks
Comparison of corneal sensation thresholds, obtained with the Cochet Bonnet esthesiometer, between the two different age groups in the study population
Comparison of corneal sensation thresholds obtained with the Cochet Bonnet esthesiometer between the two different age groups in the study population
Measured: within two weeks
Comparison of corneal sensation thresholds, obtained with the liquid jet prototype esthesiometer, between the two different age groups in the study population
Comparison of corneal sensation thresholds, obtained with the liquid jet prototype esthesiometer, between the two different age groups in the study population
Measured: within two weeks
Comparison of corneal sensation thresholds, obtained with the tactile prototype esthesiometer, between the two different age groups in the study population
Comparison of corneal sensation thresholds, obtained with the tactile prototype esthesiometer, between the two different age groups in the study population
Measured: within two weeks
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted5 Aug 2019
- Study start1 Sep 2019
- Primary completion30 Nov 2019
- Study completion30 Nov 2019
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for Cornea; Sense LossStudies 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
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Basic science
- Allocation
- Non-randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 90 participants (actual)
Sponsor and investigators
- Lead sponsor
- Daniela Nosch
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor-investigator, Daniela Nosch, University of Applied Sciences and Arts Northwestern Switzerland
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04045509
- Sponsor's protocol ID
- 2019-01252
- Other IDs
- 2019
- Status last verified
- Dec 2019
- First submitted
- 30 Jul 2019
- Last updated
- 6 Dec 2019
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Undecided
Publications
Nosch DS, Kaser E, Bracher T, Joos RE. Clinical application of the Swiss Liquid Jet Aesthesiometer for corneal sensitivity measurement. Clin Exp Optom. 2024 Jan;107(1):14-22. doi: 10.1080/08164622.2023.2191782. Epub 2023 Apr 5.
PubMed 37019837
Study at a glance
From the registry record, last updated by the sponsor on 6 Dec 2019. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Investigation in Variability and Repeatability of Corneal Sensation in a Normal Population
- ClinicalTrials.gov ID
- NCT04045509
- Acronym / sponsor ID
- 2019-01252
- Conditions
- Cornea; Sense Loss
- Keywords
- corneal sensation, subbasal nerve plexus
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 90 participants (actual)
- Lead sponsor
- Daniela NoschUniversity, hospital or other
- Study start
- 1 Sep 2019 (actual)
- Primary completion
- 30 Nov 2019 (actual)
- Study completion
- 30 Nov 2019 (actual)
- First posted
- 5 Aug 2019 (actual)
- 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.
The aim is to find out more about how corneal sensory fibres react to different types of stimuli (liquid / tactile / nylon thread) and how this can be consciously perceived by the individual. Is it possible to generate a stimulus that delivers a repeatable and reliable response within a useful stimulus force range which allows an interpretation / evaluation of normal / expected activity of superficial nerve fibres in the cornea? The study group will be divided into two age groups, as sensitivity changes are thought to occur in dependence of age. In vivo confocal microscopy has shown that the density of corneal nerve fibres in the sub-basal nerve plexus decreases with age, which consequently would suggest that sensitivity should also decrease. A very interesting research question is to find out, if such sensitivity differences can be detected with the nature of the stimuli applied in this study.
Detailed description
The aim of this study is to gain more physiological knowledge about ocular surface sensation (corneal sensitivity), with application of three different concepts employing different types of stimuli for triggering a response from the pain sensitive nerve endings in the superficial cornea: 1) liquid jet (consisting of isotonic saline solution; prototype), 2) tactile stimulus (round plastic nozzle, prototype) 3) commercially available Cochet Bonnet esthesiometer (nylon thread). Measurements will be carried out on healthy eyes of subjects in two different age groups.
Current knowledge about human corneal sensitivity is limited, as applied methods for ocular surface sensation measurement are limited with regards to reproducibility / accuracy.
Corneal sensitivity represents a neurological response from the free nerve endings within the epithelium. They are sensitive to mechanical, electrical, chemical or thermal stimuli and hence have a protective function for the cornea. Corneal nerves play an important role in cell growth and proliferation of epithelial cells, wound healing and repair. In experimental studies, corneal denervation has been reported to result in epithelial changes: increased permeability, decreased proliferation, changed appearance and delayed wound healing. Therefore, intact corneal innervation is required to maintain the integrity of a normal corneal epithelium. Corneal sensory nerves are believed to play an important role in maintaining the resting tear flow, as their afferent impulses from the ocular surface lead to a reflex response, best described by the lacrimal functional unit: an integrated system comprising the ocular surface tissues (cornea, corneal limbus, conjunctiva, conjunctival blood vessels, and eyelids), the tear secreting components (main and accessory lacrimal glands, meibomian glands, conjunctival goblet, and epithelial cells), and the sensory and motor nerves that connect them.
Current knowledge about ocular surface sensitivity is insufficient, as currently available measurement possibilities lack repeatability and accuracy. Before a new instrument can be developed, more research is required, in order to find a suitable concept for precise sensitivity measurement. For this purpose, two new different concepts with different / new stimulus types will be applied repeatably on healthy eyes in this study. The aim is to find out more about how corneal sensory fibres react to different types of stimuli (liquid / tactile / nylon thread) and how this can be consciously perceived by the individual. Is it possible to generate a stimulus that delivers a repeatable and reliable response within a useful stimulus force range which allows an interpretation / evaluation of normal / expected activity of superficial nerve fibres in the cornea? The study group will be divided into two age groups, as sensitivity changes are thought to occur in dependence of age. In vivo confocal microscopy has shown that the density of corneal nerve fibres in the sub-basal nerve plexus decreases with age, which consequently would suggest that sensitivity should also decrease. A very interesting research question is to find out, if such sensitivity differences can be detected with the nature of the stimuli applied in this study.
Study design
- Primary purpose
- Basic science
- Allocation
- Non-randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Group 'young age' | Other | Device: Liquid Jet Esthesiometer Prototype, Device: Tactile Esthesiometer Prototype, Device: Cochet Bonnet esthesiometerGroup 'young age': 18 - 30 years of age; healthy eyes |
| Group 'advanced age' | Other | Device: Liquid Jet Esthesiometer Prototype, Device: Tactile Esthesiometer Prototype, Device: Cochet Bonnet esthesiometerGroup 'advanced age': 50 - 70 years of age; healthy eyes |
Who may qualify
- Ages
- 18 to 70 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (2 listed)
- Group 'young age': 18 - 30 years of age; healthy eyes with Ocular Surface Disease Index Score </= 13
- Group 'advanced age': 50 - 70 years of age; healthy eyes with Ocular Surface Disease Index Score </= 13
Key exclusion criteria (5 listed)
- Systemic disease that may affect ocular health, such as diabetes
- Injury and history of operations on the anterior segment of the eye
- regular application of systemic or ocular medication known to affect the tear film, specifically on the day of measurement
- rigid gas permeable contact lens wear
- soft contact lens wear less than 48 hours before study visit
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Liquid Jet Esthesiometer PrototypeBalanced salt solution with a pH value similar to the tear film uesd as a liquid jet stimulus for corneal sensation threshold measurement | Device | Group 'advanced age', Group 'young age' |
| Tactile Esthesiometer PrototypeA round plastic nozzle (1.8mm diameter) used as a stimulus for corneal sensation threshold measurement | Device | Group 'advanced age', Group 'young age' |
| Cochet Bonnet esthesiometerA nylon thread (0.12mm diameter) used as a stimulus for corneal sensation threshold measurement | Device | Group 'advanced age', Group 'young age' |
Primary outcome
Repeatability of mechanical corneal sensation thresholds with the Cochet Bonnet esthesiometer
Time frame: two weeks
Evaluation of repeatability of mechanical corneal sensation thresholds for the measurement with the Cochet Bonnet instrument (in mN): the corneal sensation thresholds will be obtained with the double staircase method (with forced choice) and the stimulus represents a nylon thread, whereby its force is proportional to the length of the nylon thread applied to the corneal surface.
Repeatability of mechanical corneal sensation thresholds with the liquid jet protoype esthesiometer
Time frame: two weeks
Evaluation of repeatability of mechanical corneal sensation thresholds for the measurement with the liquid jet esthesiometer prototype instrument (in mbar): the corneal sensation thresholds will be obtained with the double staircase method (with forced choice) and the stimulus represents a liquid jet (consisting of isotonic saline solution).
Repeatability of mechanical corneal sensation thresholds with the tactile prototype esthesiometer
Time frame: two weeks
Evaluation of variability / repeatability of mechanical corneal sensation thresholds for the measurement with the tactile esthesiometer prototype instrument (in mN): the corneal sensation thresholds will be obtained with the double staircase method (with forced choice) and the stimulus represents a small, round plastic ball.
9 secondary outcomes
Correlation between corneal sensation thresholds with the Cochet Bonnet esthesiometer
Time frame: one day
Correlation between corneal sensation thresholds with the liquid jet prototype esthesiometer
Time frame: one day
Correlation between corneal sensation thresholds with the tactile prototype esthesiometer
Time frame: one day
Correlation between corneal sensitivity thresholds, obtained with the Cochet Bonnet esthesiometer, and general pain perception
Time frame: within two weeks
Correlation between corneal sensitivity thresholds, obtained with the liquid jet prototype esthesiometer, and general pain perception
Time frame: within two weeks
Correlation between corneal sensitivity thresholds, obtained with the tactile prototype esthesiometer, and general pain perception
Time frame: within two weeks
Comparison of corneal sensation thresholds, obtained with the Cochet Bonnet esthesiometer, between the two different age groups in the study population
Time frame: within two weeks
Comparison of corneal sensation thresholds, obtained with the liquid jet prototype esthesiometer, between the two different age groups in the study population
Time frame: within two weeks
Comparison of corneal sensation thresholds, obtained with the tactile prototype esthesiometer, between the two different age groups in the study population
Time frame: within two weeks
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 6 Dec 2019.
- Derived from this study: PubMed 37019837Nosch DS, Kaser E, Bracher T, Joos RE. Clinical application of the Swiss Liquid Jet Aesthesiometer for corneal sensitivity measurement. Clin Exp Optom. 2024 Jan;107(1):14-22. doi: 10.1080/08164622.2023.2191782. Epub 2023 Apr 5.
- Individual participant dataSharing planned: Undecided
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.
The record lists no contact. Use the official record to reach the sponsor.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Liquid Jet Esthesiometer Prototype, Tactile Esthesiometer Prototype and Cochet Bonnet esthesiometer in people with Cornea; Sense Loss, run by Daniela Nosch at 1 site in 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 2 inclusion and 5 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 6 Dec 2019. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Switzerland. Whether a site is taking part right now should be confirmed with that site. See every site.
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?
Repeatability of mechanical corneal sensation thresholds with the Cochet Bonnet esthesiometer (time frame: two weeks). The study lists 3 primary outcomes in all. 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 NCT04045509, which also lists 1 linked publication.
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 6 Dec 2019.