Investigation in Corneal Sensation and Contact Lens Wear

NCT04804592 | Completed DMC

• 1 other identifier: 2021-00438
• Study Type: interventional
• Target: 111
• Locations: 1 country
• Sites: 1

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.

Conditions

Cornea; Sense Loss; Cornea

Keywords

cornea; ocular surface sensation; corneal sensitivity; contact lens wear

Outcome Measures

Primary Outcomes (3)

• 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).

  two weeks

• 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.

  two weeks

• 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.

  two weeks

Secondary Outcomes (6)

• Correlation between corneal sensation thresholds with the Cochet Bonnet esthesiometer

  one day

• Correlation between corneal sensation thresholds with the liquid jet prototype esthesiometer

  one day

• Correlation between corneal sensation thresholds with the tactile prototype esthesiometer

  one day

• Comparison of corneal sensation thresholds, obtained with the Cochet Bonnet esthesiometer, between the three groups in the study population

  two weeks

• Comparison of corneal sensation thresholds, obtained with the liquid jet prototype esthesiometer, between the three groups in the study population

  two weeks

Study Arms (3)

Group A: SiHy CL

EXPERIMENTAL

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

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

Group B: RGP CL

EXPERIMENTAL

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

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

Group C: no CL wear

EXPERIMENTAL

No current CL wear for at least 3 months;

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

Interventions

Tactile Esthesiometer Prototype DEVICE

A round plastic nozzle (1.8mm diameter) used as a stimulus for corneal sensation threshold measurement

Group A: SiHy CL; Group B: RGP CL; Group C: no CL wear

Liquid Jet Esthesiometer Prototype DEVICE

Balanced salt solution with a pH value similar to the tear film uesd as a liquid jet stimulus for corneal sensation threshold measurement

Group A: SiHy CL; Group B: RGP CL; Group C: no CL wear

Cochet Bonnet esthesiometer DEVICE

A nylon thread (0.12mm diameter) used as a stimulus for corneal sensation threshold measurement

Group A: SiHy CL; Group B: RGP CL; Group C: no CL wear

Eligibility Criteria

• Age: 18 Years - 50 Years
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64)

You may qualify if:

• 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

You may not qualify if:

• 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

Sponsors & Collaborators

• Daniela Nosch: lead

Study Sites (1)

Institute of Optometry, FHNW

Olten, Canton of Solothurn, 4600, Switzerland

Location

Related Publications (10)

• 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.

  PMID: 15106930 BACKGROUND

• Bergenske PD, Polse KA. The effect of rigid gas permeable lenses on corneal sensitivity. J Am Optom Assoc. 1987 Mar;58(3):212-5.

  PMID: 3471806 BACKGROUND

• 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.

  PMID: 5270397 BACKGROUND

• 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.

  PMID: 923715 BACKGROUND

• 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.

  PMID: 12697417 BACKGROUND

• 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.

  PMID: 28338565 BACKGROUND

• 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.

  PMID: 31592962 BACKGROUND

• 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.

  PMID: 18382334 BACKGROUND

• 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.

  PMID: 25649641 BACKGROUND

• 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.

  PMID: 22281824 BACKGROUND

MeSH Terms

Conditions

Corneal Diseases

Condition Hierarchy (Ancestors)

Eye Diseases

Study Officials

• Daniela S Nosch, PhD

  University of Applied Sciences and Arts Northwestern Switzerland FHNW

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: NON RANDOMIZED
• Masking: NONE
• Purpose: BASIC SCIENCE
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR INVESTIGATOR
• PI Title: Professor

Study Record Dates

• First Submitted: March 11, 2021
• First Posted: March 18, 2021
• Study Start: May 1, 2021
• Primary Completion: December 20, 2021
• Study Completion: December 20, 2021
• Last Updated: March 17, 2022

Record last verified: 2022-03

Data Sharing

• IPD Sharing: Will not share

Locations

CH (1)