Influence of Silicone Hydrogel Extended Contact Lens Wear on Corneal Sensitivity

Cornea Clinical Trial

Official title:

Influence of Silicone Hydrogel Extended Contact Lens Wear on Corneal Sensitivity

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT05298917
• Other study ID #: 2022-D0011
• Status: Completed
• Phase: N/A
• Start date: April 1, 2022
• Est. completion date: August 18, 2022

Study information

• Verified date: January 2023
• Source: University of Applied Sciences and Arts Northwestern Switzerland
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 30
• Est. completion date: August 18, 2022
• Est. primary completion date: August 18, 2022
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: All
• Age group: 18 Years and older

Eligibility

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

Related Conditions & MeSH terms

• Cornea
• Hypersensitivity

Intervention

Device:
• silicone hydrogel contact lens
silicone hydrogel contact lens

Locations

Country	Name	City	State
Switzerland	Institute of Optometry	Olten	Solothurn

Sponsors (1)

Lead Sponsor	Collaborator
Daniela Nosch

Country where clinical trial is conducted

Switzerland, 

References & Publications (5)

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. — View 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. — View 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. — View 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. — View 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. — View Citation

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	difference in corneal sensitivity threshold baseline and after 7 days of extended contact lens wear	The difference in corneal sensitivity threshold baseline versus after 7 days of extended contact lens wear will be determined. Corneal sensitivity measurement will take place with the Swiss Liquid Jet Aesthesiometer for Corneal Sensitivity (SLACS) and will be recorded in mbar.	7+/-1 days
Secondary	correlation between corneal sensitvity threshold and subjective symptoms	correlation between corneal sensitvity threshold and subjective symptoms after 7 days of extended contact lens wear: corneal sensitivity threshold will be determinded with the Swiss Liquid Jet Aesthesiometer for Corneal Sensitivity (SLACS) and will be recorded in mbar. Subjective Symptoms will be recorded with the CLEDQ8 questionnaire (specifically designed to assess contact lens comfort)	7+/-1 days