Ignite Creation Date:
2024-05-06 @ 3:55 PM
Last Modification Date:
2024-10-26 @ 1:59 PM
Study NCT ID:
NCT04804592
Status:
COMPLETED
Last Update Posted:
2022-03-17
First Post:
2021-03-11
Brief Title:
Investigation in Corneal Sensation and Contact Lens Wear
Sponsor:
Daniela Nosch
Organization:
University of Applied Sciences and Arts Northwestern Switzerland
Study Overview
Official Title:
Investigation in Variability and Repeatability of Corneal Sensation in a Normal Population and Contact Lens Wearers
Status:
COMPLETED
Status Verified Date:
2022-03
Last Known Status:
None
Delayed Posting:
No
If Stopped, Why?:
Not Stopped
Has Expanded Access:
False
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
None
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 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 mm3 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
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 Oversight
Has Oversight DMC:
None
Is a FDA Regulated Drug?:
False
Is a FDA Regulated Device?:
False
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
None
Is an FDA AA801 Violation?:
None