Investigation in Corneal Sensation
- Conditions
- Cornea; Sense Loss
- Interventions
- Device: Liquid Jet Esthesiometer PrototypeDevice: Tactile Esthesiometer PrototypeDevice: Cochet Bonnet esthesiometer
- Registration Number
- NCT04045509
- Lead Sponsor
- Daniela Nosch
- Brief 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. 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.
Recruitment & Eligibility
- Status
- COMPLETED
- Sex
- All
- Target Recruitment
- 90
- 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
- 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
Study & Design
- Study Type
- INTERVENTIONAL
- Study Design
- PARALLEL
- Arm && Interventions
Group Intervention Description Group 'young age' Tactile Esthesiometer Prototype Group 'young age': 18 - 30 years of age; healthy eyes Group 'young age' Liquid Jet Esthesiometer Prototype Group 'young age': 18 - 30 years of age; healthy eyes Group 'young age' Cochet Bonnet esthesiometer Group 'young age': 18 - 30 years of age; healthy eyes Group 'advanced age' Liquid Jet Esthesiometer Prototype Group 'advanced age': 50 - 70 years of age; healthy eyes Group 'advanced age' Tactile Esthesiometer Prototype Group 'advanced age': 50 - 70 years of age; healthy eyes Group 'advanced age' Cochet Bonnet esthesiometer Group 'advanced age': 50 - 70 years of age; healthy eyes
- Primary Outcome Measures
Name Time Method Repeatability of mechanical corneal sensation thresholds with the liquid jet protoype esthesiometer 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 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 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.
- Secondary Outcome Measures
Name Time Method Correlation between corneal sensation thresholds with the liquid jet prototype esthesiometer one day Correlation between corneal sensitivity thresholds (in mbar) obtained with the liquid jet prototype esthesiometer
Correlation between corneal sensitivity thresholds, obtained with the liquid jet prototype esthesiometer, and general pain perception within two weeks Correlation between corneal sensitivity thresholds, obtained with the liquid jet prototype esthesiometer, and general pain perception
Comparison of corneal sensation thresholds, obtained with the tactile prototype esthesiometer, between the two different age groups in the study population within two weeks Comparison of corneal sensation thresholds, obtained with the tactile prototype esthesiometer, between the two different age groups in the study population
Correlation between corneal sensation thresholds with the Cochet Bonnet esthesiometer one day Correlation between corneal sensitivity thresholds (in mN) obtained with the Cochet Bonnet esthesiometer
Correlation between corneal sensitivity thresholds, obtained with the Cochet Bonnet esthesiometer, and general pain perception within two weeks 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.
Comparison of corneal sensation thresholds, obtained with the liquid jet prototype esthesiometer, between the two different age groups in the study population 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
Correlation between corneal sensation thresholds with the tactile prototype esthesiometer one day Correlation between corneal sensitivity thresholds (in mN) obtained with the tactile prototype esthesiometer
Correlation between corneal sensitivity thresholds, obtained with the tactile prototype esthesiometer, and general pain perception within two weeks Correlation between corneal sensitivity thresholds, obtained with the tactile prototype esthesiometer, and general pain perception
Comparison of corneal sensation thresholds, obtained with the Cochet Bonnet esthesiometer, between the two different age groups in the study population within two weeks Comparison of corneal sensation thresholds obtained with the Cochet Bonnet esthesiometer between the two different age groups in the study population
Trial Locations
- Locations (1)
Institute of Optometry, FHNW
🇨🇭Olten, Solothurn, Switzerland