Institute of Optometry, FHNW
Olten, Canton of Solothurn, 4600, Switzerland
NCT Number: NCT04804592
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.
Looking for future studies?
Notify Me18 year–50 year
All sexes
Interventional
Not applicable
Olten, Canton of Solothurn, 4600, Switzerland
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.
Healthy volunteers accepted: Yes
Only the study team can determine whether someone qualifies for participation.
Inclusion criteria
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
Exclusion criteria
A round plastic nozzle (1.8mm diameter) used as a stimulus for corneal sensation threshold measurement
Balanced salt solution with a pH value similar to the tear film uesd as a liquid jet stimulus for corneal sensation threshold measurement
A nylon thread (0.12mm diameter) used as a stimulus for corneal sensation threshold measurement
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).
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.
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.
Time frame: one day
Correlation between corneal sensitivity thresholds (in mN) obtained with the Cochet Bonnet esthesiometer
Time frame: one day
Correlation between corneal sensitivity thresholds (in mbar) obtained with the liquid jet prototype esthesiometer
Time frame: one day
Correlation between corneal sensitivity thresholds (in mN) obtained with the tactile prototype esthesiometer
Time frame: two weeks
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
Daniela Nosch
Other
Investigation in Variability and Repeatability of Corneal Sensation in a Normal Population and Contact Lens Wearers
OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.
View the official ClinicalTrials.gov record (opens in a new tab)This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.
Published trials that share one or more normalized conditions with this study.
NCT07693673
Cornea, Corneal Diseases
Sohag, Sohag Governorate, Egypt
View Trial DetailsNCT05204329
Cornea, Corneal Defect
Chicago, Illinois, United States
View Trial DetailsNCT06759207
Cornea, Corneal Diseases
Sohag, Egypt
View Trial DetailsNCT04626583
Cornea, Corneal Defect
Chicago, Illinois, United States
View Trial Details