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Investigation in Corneal Sensation and Contact Lens Wear

D

Daniela Nosch

Status

Completed

Conditions

Sense Loss; Cornea
Cornea

Treatments

Device: Tactile Esthesiometer Prototype
Device: Liquid Jet Esthesiometer Prototype
Device: Cochet Bonnet esthesiometer

Study type

Interventional

Funder types

Other

Identifiers

NCT04804592
2021-00438

Details and patient eligibility

About

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.

Full 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.

Enrollment

111 patients

Sex

All

Ages

18 to 50 years old

Volunteers

Accepts Healthy Volunteers

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

  • 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 design

Primary purpose

Basic Science

Allocation

Non-Randomized

Interventional model

Parallel Assignment

Masking

None (Open label)

111 participants in 3 patient groups

Group A: SiHy CL
Experimental group
Description:
Silicone hydrogel (SiHy) CL wear at least 3 days per week and at least 8 hours per day;
Treatment:
Device: Liquid Jet Esthesiometer Prototype
Device: Cochet Bonnet esthesiometer
Device: Tactile Esthesiometer Prototype
Group B: RGP CL
Experimental group
Description:
Rigid gas permeable (RGP) CL wear at least 3 days per week and at least 8 hours per day;
Treatment:
Device: Liquid Jet Esthesiometer Prototype
Device: Cochet Bonnet esthesiometer
Device: Tactile Esthesiometer Prototype
Group C: no CL wear
Experimental group
Description:
No current CL wear for at least 3 months;
Treatment:
Device: Liquid Jet Esthesiometer Prototype
Device: Cochet Bonnet esthesiometer
Device: Tactile Esthesiometer Prototype

Trial contacts and locations

1

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Data sourced from clinicaltrials.gov

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