CorneaNCT04804592
Investigation in Corneal Sensation and Contact Lens Wear
A study testing Tactile Esthesiometer Prototype, Liquid Jet Esthesiometer Prototype and Cochet Bonnet esthesiometer in people with Cornea and Sense Loss; Cornea, 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 50 yearsHealthy volunteers can take part
- Conditions the study is for
- Cornea, Sense Loss; Cornea
- What is being tested?
- Tactile Esthesiometer Prototype, Liquid Jet 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
- 111 participants
- Where
- 1 siteSwitzerland
- Study dates
- 1 May 2021to 20 Dec 2021
- 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 50 years
- All sexes
- Healthy volunteers accepted
- Adult
Who may be able to join
- Group A:
- Silicone hydrogel (SiHy) CL wear at least 3 days per week and at least 8 hours per day; 18 - 50 years of age; healthy eyes with OSDI </= 13
- Group B:
- Rigid gas permeable (RGP) CL wear at least 3 days per week and at least 8 hours per day; 18 - 50 years of age; healthy eyes with OSDI </= 13
- Group C:
- No current CL wear for at least 3 months; 18 - 50 years of age; healthy eyes with OSDI </= 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
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 and Contact Lens Wearers
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 three groups of individuals: two groups with different types of contact lenses (CL) and one without CL, as sensitivity changes are thought to occur with CL wear. 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) tactile method: a round plastic nozzle (2 mm diameter) is applied to the ocular surface with a defined, low force for a duration of 100ms. 2) liquid jet method: a liquid jet (isotonic saline) of a temperature to match ocular surface temperature is applied to the ocular surface with low pressure and low volume, from a distance of 15 mm.3) commercially available Cochet Bonnet esthesiometer (nylon thread). The study group will be divided into three groups of individuals: two groups with different types of contact lenses (CL) and one without CL, as sensitivity changes are thought to occur with CL wear. 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.
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 three groups of individuals: two groups with different types of contact lenses (CL) and one without CL, as sensitivity changes are thought to occur with CL wear.
- Conditions
- Cornea, Sense Loss; Cornea
- Being tested
- Tactile Esthesiometer Prototype, Liquid Jet Esthesiometer Prototype, Cochet Bonnet esthesiometer
- Keywords
- cornea, ocular surface sensation, corneal sensitivity, contact lens wear
- Medical subject headings
- Corneal Diseases
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Tactile Esthesiometer PrototypeDevice
A round plastic nozzle (1.8mm diameter) used as a stimulus for corneal sensation threshold measurement
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
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 A: SiHy CL | Experimental | Silicone hydrogel (SiHy) CL wear at least 3 days per week and at least 8 hours per day; Receives: Device: Tactile Esthesiometer Prototype; Device: Liquid Jet Esthesiometer Prototype; Device: Cochet Bonnet esthesiometer |
| Group B: RGP CL | Experimental | Rigid gas permeable (RGP) CL wear at least 3 days per week and at least 8 hours per day; Receives: Device: Tactile Esthesiometer Prototype; Device: Liquid Jet Esthesiometer Prototype; Device: Cochet Bonnet esthesiometer |
| Group C: no CL wear | Experimental | No current CL wear for at least 3 months; Receives: Device: Tactile Esthesiometer Prototype; Device: Liquid Jet 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 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
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
Secondary outcomes (6)
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
Comparison of corneal sensation thresholds, obtained with the Cochet Bonnet esthesiometer, between the three groups in the study population
Comparison of corneal sensation thresholds obtained with the Cochet Bonnet esthesiometer between the three groups in the study population
Measured: two weeks
Comparison of corneal sensation thresholds, obtained with the liquid jet prototype esthesiometer, between the three groups in the study population
Comparison of corneal sensation thresholds, obtained with the liquid jet prototype esthesiometer, between the three groups in the study population
Measured: two weeks
Comparison of corneal sensation thresholds, obtained with the tactile prototype esthesiometer, between the three groups in the study population
Comparison of corneal sensation thresholds, obtained with the tactile prototype esthesiometer, between the three groups in the study population
Measured: two weeks
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted18 Mar 2021
- Study start1 May 2021
- Primary completion20 Dec 2021
- Study completion20 Dec 2021
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (10)Papers the sponsor has linked to this study.
- Other trials for CorneaStudies 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
- 111 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
- Investigators
- Daniela S Nosch, PhD, Principal investigator, University of Applied Sciences and Arts Northwestern Switzerland FHNW
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04804592
- Sponsor's protocol ID
- 2021-00438
- Status last verified
- Mar 2022
- First submitted
- 11 Mar 2021
- Last updated
- 17 Mar 2022
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Publications
Belmonte C, Acosta MC, Gallar J. Neural basis of sensation in intact and injured corneas. Exp Eye Res. 2004 Mar;78(3):513-25. doi: 10.1016/j.exer.2003.09.023.
PubMed 15106930Bergenske PD, Polse KA. The effect of rigid gas permeable lenses on corneal sensitivity. J Am Optom Assoc. 1987 Mar;58(3):212-5.
PubMed 3471806Knoll HA, Williams J. Effects of hydrophilic contact lenses on corneal sensitivity. Am J Optom Arch Am Acad Optom. 1970 Jul;47(7):561-3. doi: 10.1097/00006324-197007000-00007. No abstract available.
PubMed 5270397Millodot M. Does the long term wear of contact lenses produce a loss of corneal sensitivity? Experientia. 1977 Nov 15;33(11):1475-6. doi: 10.1007/BF01918817.
PubMed 923715Muller LJ, Marfurt CF, Kruse F, Tervo TM. Corneal nerves: structure, contents and function. Exp Eye Res. 2003 May;76(5):521-42. doi: 10.1016/s0014-4835(03)00050-2.
PubMed 12697417Golebiowski B, Chao C, Stapleton F, Jalbert I. Corneal Nerve Morphology, Sensitivity, and Tear Neuropeptides in Contact Lens Wear. Optom Vis Sci. 2017 Apr;94(4):534-542. doi: 10.1097/OPX.0000000000001063.
PubMed 28338565Stapleton F, Chao C, Golebiowski B. Topical Review: Effects of Contact Lens Wear on Corneal, Conjunctival, and Lid Margin Sensitivity. Optom Vis Sci. 2019 Oct;96(10):790-801. doi: 10.1097/OPX.0000000000001429.
PubMed 31592962Golebiowski B, Papas EB, Stapleton F. Factors affecting corneal and conjunctival sensitivity measurement. Optom Vis Sci. 2008 Apr;85(4):241-6. doi: 10.1097/OPX.0b013e3181694f96.
PubMed 18382334Stapleton F, Golebiowski B, Skotnitsky C, Tan ME, Holden BA. Corneal and conjunctival sensitivity in intolerant contact lens wearers. J Optom. 2015 Jan-Mar;8(1):62-3. doi: 10.1016/j.optom.2014.05.004. Epub 2014 Jun 7. No abstract available.
PubMed 25649641Golebiowski B, Papas EB, Stapleton F. Corneal and conjunctival sensory function: the impact on ocular surface sensitivity of change from low to high oxygen transmissibility contact lenses. Invest Ophthalmol Vis Sci. 2012 Mar 9;53(3):1177-81. doi: 10.1167/iovs.11-8416.
PubMed 22281824
Study at a glance
From the registry record, last updated by the sponsor on 17 Mar 2022. 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 and Contact Lens Wearers
- ClinicalTrials.gov ID
- NCT04804592
- Acronym / sponsor ID
- 2021-00438
- Conditions
- Cornea, Sense Loss; Cornea
- Keywords
- cornea, ocular surface sensation, corneal sensitivity, contact lens wear
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 111 participants (actual)
- Lead sponsor
- Daniela NoschUniversity, hospital or other
- Study start
- 1 May 2021 (actual)
- Primary completion
- 20 Dec 2021 (actual)
- Study completion
- 20 Dec 2021 (actual)
- First posted
- 18 Mar 2021 (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 three groups of individuals: two groups with different types of contact lenses (CL) and one without CL, as sensitivity changes are thought to occur with CL wear. 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) tactile method: a round plastic nozzle (2 mm diameter) is applied to the ocular surface with a defined, low force for a duration of 100ms. 2) liquid jet method: a liquid jet (isotonic saline) of a temperature to match ocular surface temperature is applied to the ocular surface with low pressure and low volume, from a distance of 15 mm.3) commercially available Cochet Bonnet esthesiometer (nylon thread). The study group will be divided into three groups of individuals: two groups with different types of contact lenses (CL) and one without CL, as sensitivity changes are thought to occur with CL wear. 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.
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 three groups of individuals: two groups with different types of contact lenses (CL) and one without CL, as sensitivity changes are thought to occur with CL wear.
Study design
- Primary purpose
- Basic science
- Allocation
- Non-randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 3
| Arm | Type | Receives |
|---|---|---|
| Group A: SiHy CL | Experimental | Device: Tactile Esthesiometer Prototype, Device: Liquid Jet Esthesiometer Prototype, Device: Cochet Bonnet esthesiometerSilicone hydrogel (SiHy) CL wear at least 3 days per week and at least 8 hours per day; |
| Group B: RGP CL | Experimental | Device: Tactile Esthesiometer Prototype, Device: Liquid Jet Esthesiometer Prototype, Device: Cochet Bonnet esthesiometerRigid gas permeable (RGP) CL wear at least 3 days per week and at least 8 hours per day; |
| Group C: no CL wear | Experimental | Device: Tactile Esthesiometer Prototype, Device: Liquid Jet Esthesiometer Prototype, Device: Cochet Bonnet esthesiometerNo current CL wear for at least 3 months; |
Who may qualify
- Ages
- 18 to 50 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult
Key inclusion criteria (6 listed)
- Silicone hydrogel (SiHy) CL wear at least 3 days per week and at least 8 hours per day; 18 - 50 years of age; healthy eyes with OSDI </= 13
- Rigid gas permeable (RGP) CL wear at least 3 days per week and at least 8 hours per day; 18 - 50 years of age; healthy eyes with OSDI </= 13
- No current CL wear for at least 3 months; 18 - 50 years of age; healthy eyes with OSDI </= 13
Key exclusion criteria (3 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
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 |
|---|---|---|
| Tactile Esthesiometer PrototypeA round plastic nozzle (1.8mm diameter) used as a stimulus for corneal sensation threshold measurement | Device | Group A: SiHy CL, Group B: RGP CL, Group C: no CL wear |
| 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 A: SiHy CL, Group B: RGP CL, Group C: no CL wear |
| Cochet Bonnet esthesiometerA nylon thread (0.12mm diameter) used as a stimulus for corneal sensation threshold measurement | Device | Group A: SiHy CL, Group B: RGP CL, Group C: no CL wear |
Primary outcome
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.
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.
6 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
Comparison of corneal sensation thresholds, obtained with the Cochet Bonnet esthesiometer, between the three groups in the study population
Time frame: two weeks
Comparison of corneal sensation thresholds, obtained with the liquid jet prototype esthesiometer, between the three groups in the study population
Time frame: two weeks
Comparison of corneal sensation thresholds, obtained with the tactile prototype esthesiometer, between the three groups in the study population
Time frame: 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 17 Mar 2022.
- Background: PubMed 15106930Belmonte C, Acosta MC, Gallar J. Neural basis of sensation in intact and injured corneas. Exp Eye Res. 2004 Mar;78(3):513-25. doi: 10.1016/j.exer.2003.09.023.
- Background: PubMed 3471806Bergenske PD, Polse KA. The effect of rigid gas permeable lenses on corneal sensitivity. J Am Optom Assoc. 1987 Mar;58(3):212-5.
- Background: PubMed 5270397Knoll HA, Williams J. Effects of hydrophilic contact lenses on corneal sensitivity. Am J Optom Arch Am Acad Optom. 1970 Jul;47(7):561-3. doi: 10.1097/00006324-197007000-00007. No abstract available.
- Background: PubMed 923715Millodot M. Does the long term wear of contact lenses produce a loss of corneal sensitivity? Experientia. 1977 Nov 15;33(11):1475-6. doi: 10.1007/BF01918817.
- Background: PubMed 12697417Muller LJ, Marfurt CF, Kruse F, Tervo TM. Corneal nerves: structure, contents and function. Exp Eye Res. 2003 May;76(5):521-42. doi: 10.1016/s0014-4835(03)00050-2.
- Background: PubMed 28338565Golebiowski B, Chao C, Stapleton F, Jalbert I. Corneal Nerve Morphology, Sensitivity, and Tear Neuropeptides in Contact Lens Wear. Optom Vis Sci. 2017 Apr;94(4):534-542. doi: 10.1097/OPX.0000000000001063.
- Background: PubMed 31592962Stapleton F, Chao C, Golebiowski B. Topical Review: Effects of Contact Lens Wear on Corneal, Conjunctival, and Lid Margin Sensitivity. Optom Vis Sci. 2019 Oct;96(10):790-801. doi: 10.1097/OPX.0000000000001429.
- Background: PubMed 18382334Golebiowski B, Papas EB, Stapleton F. Factors affecting corneal and conjunctival sensitivity measurement. Optom Vis Sci. 2008 Apr;85(4):241-6. doi: 10.1097/OPX.0b013e3181694f96.
- Background: PubMed 25649641Stapleton F, Golebiowski B, Skotnitsky C, Tan ME, Holden BA. Corneal and conjunctival sensitivity in intolerant contact lens wearers. J Optom. 2015 Jan-Mar;8(1):62-3. doi: 10.1016/j.optom.2014.05.004. Epub 2014 Jun 7. No abstract available.
- Background: PubMed 22281824Golebiowski B, Papas EB, Stapleton F. Corneal and conjunctival sensory function: the impact on ocular surface sensitivity of change from low to high oxygen transmissibility contact lenses. Invest Ophthalmol Vis Sci. 2012 Mar 9;53(3):1177-81. doi: 10.1167/iovs.11-8416.
- Individual participant dataSharing planned: No
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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.
Daniela S Nosch, PhD principal investigator
University of Applied Sciences and Arts Northwestern Switzerland FHNW
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Tactile Esthesiometer Prototype, Liquid Jet Esthesiometer Prototype and Cochet Bonnet esthesiometer in people with Cornea and Sense Loss; Cornea, 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 6 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 17 Mar 2022. 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 liquid jet protoype 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 NCT04804592, which also lists 10 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 17 Mar 2022.