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Investigation in Corneal Sensation and Contact Lens Wear

Primary Purpose

Cornea, Sense Loss; Cornea

Status
Completed
Phase
Not Applicable
Locations
Switzerland
Study Type
Interventional
Intervention
Tactile Esthesiometer Prototype
Liquid Jet Esthesiometer Prototype
Cochet Bonnet esthesiometer
Sponsored by
Daniela Nosch
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional basic science trial for Cornea focused on measuring cornea, ocular surface sensation, corneal sensitivity, contact lens wear

Eligibility Criteria

18 Years - 50 Years (Adult)All SexesAccepts 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

Sites / Locations

  • Institute of Optometry, FHNW

Arms of the Study

Arm 1

Arm 2

Arm 3

Arm Type

Experimental

Experimental

Experimental

Arm Label

Group A: SiHy CL

Group B: RGP CL

Group C: no CL wear

Arm Description

Silicone hydrogel (SiHy) CL wear at least 3 days per week and at least 8 hours per day;

Rigid gas permeable (RGP) CL wear at least 3 days per week and at least 8 hours per day;

No current CL wear for at least 3 months;

Outcomes

Primary Outcome Measures

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).
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.
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.

Secondary Outcome Measures

Correlation between corneal sensation thresholds with the Cochet Bonnet esthesiometer
Correlation between corneal sensitivity thresholds (in mN) obtained with the Cochet Bonnet esthesiometer
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
Correlation between corneal sensation thresholds with the tactile prototype esthesiometer
Correlation between corneal sensitivity thresholds (in mN) obtained with the tactile prototype esthesiometer
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
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
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

Full Information

First Posted
March 11, 2021
Last Updated
March 16, 2022
Sponsor
Daniela Nosch
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1. Study Identification

Unique Protocol Identification Number
NCT04804592
Brief Title
Investigation in Corneal Sensation and Contact Lens Wear
Official Title
Investigation in Variability and Repeatability of Corneal Sensation in a Normal Population and Contact Lens Wearers
Study Type
Interventional

2. Study Status

Record Verification Date
March 2022
Overall Recruitment Status
Completed
Study Start Date
May 1, 2021 (Actual)
Primary Completion Date
December 20, 2021 (Actual)
Study Completion Date
December 20, 2021 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor-Investigator
Name of the Sponsor
Daniela Nosch

4. Oversight

Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
Yes

5. Study Description

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 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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Cornea, Sense Loss; Cornea
Keywords
cornea, ocular surface sensation, corneal sensitivity, contact lens wear

7. Study Design

Primary Purpose
Basic Science
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
None (Open Label)
Allocation
Non-Randomized
Enrollment
111 (Actual)

8. Arms, Groups, and Interventions

Arm Title
Group A: SiHy CL
Arm Type
Experimental
Arm Description
Silicone hydrogel (SiHy) CL wear at least 3 days per week and at least 8 hours per day;
Arm Title
Group B: RGP CL
Arm Type
Experimental
Arm Description
Rigid gas permeable (RGP) CL wear at least 3 days per week and at least 8 hours per day;
Arm Title
Group C: no CL wear
Arm Type
Experimental
Arm Description
No current CL wear for at least 3 months;
Intervention Type
Device
Intervention Name(s)
Tactile Esthesiometer Prototype
Intervention Description
A round plastic nozzle (1.8mm diameter) used as a stimulus for corneal sensation threshold measurement
Intervention Type
Device
Intervention Name(s)
Liquid Jet Esthesiometer Prototype
Intervention Description
Balanced salt solution with a pH value similar to the tear film uesd as a liquid jet stimulus for corneal sensation threshold measurement
Intervention Type
Device
Intervention Name(s)
Cochet Bonnet esthesiometer
Intervention Description
A nylon thread (0.12mm diameter) used as a stimulus for corneal sensation threshold measurement
Primary Outcome Measure Information:
Title
Repeatability of mechanical corneal sensation thresholds with the liquid jet protoype esthesiometer
Description
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
Title
Repeatability of mechanical corneal sensation thresholds with the tactile prototype esthesiometer
Description
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
Title
Repeatability of mechanical corneal sensation thresholds with the Cochet Bonnet esthesiometer
Description
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
two weeks
Secondary Outcome Measure Information:
Title
Correlation between corneal sensation thresholds with the Cochet Bonnet esthesiometer
Description
Correlation between corneal sensitivity thresholds (in mN) obtained with the Cochet Bonnet esthesiometer
Time Frame
one day
Title
Correlation between corneal sensation thresholds with the liquid jet prototype esthesiometer
Description
Correlation between corneal sensitivity thresholds (in mbar) obtained with the liquid jet prototype esthesiometer
Time Frame
one day
Title
Correlation between corneal sensation thresholds with the tactile prototype esthesiometer
Description
Correlation between corneal sensitivity thresholds (in mN) obtained with the tactile prototype esthesiometer
Time Frame
one day
Title
Comparison of corneal sensation thresholds, obtained with the Cochet Bonnet esthesiometer, between the three groups in the study population
Description
Comparison of corneal sensation thresholds obtained with the Cochet Bonnet esthesiometer between the three groups in the study population
Time Frame
two weeks
Title
Comparison of corneal sensation thresholds, obtained with the liquid jet prototype esthesiometer, between the three groups in the study population
Description
Comparison of corneal sensation thresholds, obtained with the liquid jet prototype esthesiometer, between the three groups in the study population
Time Frame
two weeks
Title
Comparison of corneal sensation thresholds, obtained with the tactile prototype esthesiometer, between the three groups in the study population
Description
Comparison of corneal sensation thresholds, obtained with the tactile prototype esthesiometer, between the three groups in the study population
Time Frame
two weeks

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
50 Years
Accepts Healthy Volunteers
Accepts Healthy Volunteers
Eligibility Criteria
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
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Daniela S Nosch, PhD
Organizational Affiliation
University of Applied Sciences and Arts Northwestern Switzerland FHNW
Official's Role
Principal Investigator
Facility Information:
Facility Name
Institute of Optometry, FHNW
City
Olten
State/Province
Solothurn
ZIP/Postal Code
4600
Country
Switzerland

12. IPD Sharing Statement

Plan to Share IPD
No
Citations:
PubMed Identifier
15106930
Citation
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.
Results Reference
background
PubMed Identifier
3471806
Citation
Bergenske PD, Polse KA. The effect of rigid gas permeable lenses on corneal sensitivity. J Am Optom Assoc. 1987 Mar;58(3):212-5.
Results Reference
background
PubMed Identifier
5270397
Citation
Knoll 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.
Results Reference
background
PubMed Identifier
923715
Citation
Millodot 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.
Results Reference
background
PubMed Identifier
12697417
Citation
Muller 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. Erratum In: Exp Eye Res. 2003 Aug;77(2):253.
Results Reference
background
PubMed Identifier
28338565
Citation
Golebiowski 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.
Results Reference
background
PubMed Identifier
31592962
Citation
Stapleton 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.
Results Reference
background
PubMed Identifier
18382334
Citation
Golebiowski 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.
Results Reference
background
PubMed Identifier
25649641
Citation
Stapleton 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.
Results Reference
background
PubMed Identifier
22281824
Citation
Golebiowski 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.
Results Reference
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Investigation in Corneal Sensation and Contact Lens Wear

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