Clinical trial NCT05298917: Influence of Silicone Hydrogel Extended Contact Lens Wear on Corneal Sensitivity
Official title: Influence of Silicone Hydrogel Extended Contact Lens Wear on Corneal Sensitivity
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Cornea
Keywords: silicone hydrogel contact lens
extended contact lens wear
corneal sensitivity
esthesiometry
Lead sponsor: University of Applied Sciences and Arts Northwestern Switzerland
Sponsor class: OTHER
First posted: 2022-03-28
Enrollment: 30
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Allocation: NA
Intervention model: SINGLE_GROUP
Primary purpose: OTHER

Brief summary: Soft contact lens wear reduces the amount of oxygen reaching the eye, which may have an influence on corneal sensitivity. The aim of this study is to measure corneal sensitivity with means of liquid jet esthesiometry at baseline and after 6 days of continuous, extended contact lens wear.

Detailed description: Contact lens wear may have an influence on corneal sensitivity, by three mechanisms: hypoxic, mechanical and inflammatory. Extended silicone hydrogel contact lens wear increases the risk of infections. A change in corneal sensitivity may be considered as an indicator for change in corneal physiology. It is there the aim of this study is to measure corneal sensitivity with means of liquid jet esthesiometry at baseline and after 6 days of continuous, extended contact lens wear.

Eligibility criteria: Inclusion Criteria:

* no contact lens wear three days before first visit
* corneal radius between 7.4 and 8.0; if corneal radius \>8.0, corneal diameter must be at least 12 mm; if corneal radius \< 7.4, corneal diameter must be \< 12.0
* OSDI score no higher than 13 points

Exclusion Criteria:

* systemic disease that may have an influence ocular healtjh
* active ocular disease and no history of ocular surgery

Primary outcomes:
measure: difference in corneal sensitivity threshold baseline and after 7 days of extended contact lens wear
timeFrame: 7+/-1 days
Secondary outcomes:
measure: correlation between corneal sensitvity threshold and subjective symptoms
timeFrame: 7+/-1 days
Other outcomes:
Locations:
city: Olten
country: Switzerland
facility: Institute of Optometry
state: Solothurn
Study officials:
affiliation: Institute of Optometry, FHNW
name: Daniela Nosch, PhD
role: PRINCIPAL_INVESTIGATOR
References:
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.
citation: Cheng KH, Leung SL, Hoekman HW, Beekhuis WH, Mulder PG, Geerards AJ, Kijlstra A. Incidence of contact-lens-associated microbial keratitis and its related morbidity. Lancet. 1999 Jul 17;354(9174):181-5. doi: 10.1016/S0140-6736(98)09385-4.
citation: Morgan PB, Murphy PJ, Gifford KL, Gifford P, Golebiowski B, Johnson L, Makrynioti D, Moezzi AM, Moody K, Navascues-Cornago M, Schweizer H, Swiderska K, Young G, Willcox M. CLEAR - Effect of contact lens materials and designs on the anatomy and physiology of the eye. Cont Lens Anterior Eye. 2021 Apr;44(2):192-219. doi: 10.1016/j.clae.2021.02.006. Epub 2021 Mar 25.
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.
citation: Nosch DS, Oscity M, Steigmeier P, Kaser E, Loepfe M, Joos RE. Working principle and relevant physical properties of the Swiss Liquid Jet Aesthesiometer for Corneal Sensitivity (SLACS) evaluation. Ophthalmic Physiol Opt. 2022 May;42(3):609-618. doi: 10.1111/opo.12962. Epub 2022 Feb 14.