Influence of Silicone Hydrogel Extended Contact Lens Wear on Corneal Sensitivity

Not Applicable

Completed

• Conditions: Cornea
• Interventions: Device: silicone hydrogel contact lens

• Registration Number: NCT05298917
• Lead Sponsor: Daniela Nosch

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.

Study Timeline

• Study First Submitted: 2022-03-16
• Study First Submitted QC: 2022-03-25
• Study First Posted: 2022-03-28
• Study Start: 2022-04-01
• Primary Completion: 2022-08-18
• Study Completion: 2022-08-18
• Status Verified: 2023-01
• Last Update Submitted: 2023-01-24
• Last Update Posted: 2023-01-26

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 30

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

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: SINGLE_GROUP

Arm && Interventions

Group	Intervention	Description
extended contact lens wear	silicone hydrogel contact lens	subjects wear silicone hydrogel contact lenses continuously for 7+/- 1 days - corneal sensitivity will be measured and compared at baseline versus after extended contact lens wear

Primary Outcome Measures

Name	Time	Method
difference in corneal sensitivity threshold baseline and after 7 days of extended contact lens wear	7+/-1 days	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.

Secondary Outcome Measures

Name	Time	Method
correlation between corneal sensitvity threshold and subjective symptoms	7+/-1 days	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)

Trial Locations

Locations (1)

Institute of Optometry; 🇨🇭 Olten, Solothurn, Switzerland