Influence of Silicone Hydrogel Extended Contact Lens Wear on Corneal Sensitivity

NCT ID: NCT05298917

Last Updated: 2023-01-26

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

NA

Total Enrollment

30 participants

Study Classification

INTERVENTIONAL

Study Start Date

2022-04-01

Study Completion Date

2022-08-18

Brief Summary

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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

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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.

Conditions

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Cornea

Study Design

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Allocation Method

NA

Intervention Model

SINGLE_GROUP

Primary Study Purpose

OTHER

Blinding Strategy

NONE

Study Groups

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extended contact lens wear

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

Group Type OTHER

silicone hydrogel contact lens

Intervention Type DEVICE

silicone hydrogel contact lens

Interventions

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silicone hydrogel contact lens

silicone hydrogel contact lens

Intervention Type DEVICE

Eligibility Criteria

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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
Minimum Eligible Age

18 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

Yes

Sponsors

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Daniela Nosch

OTHER

Sponsor Role lead

Responsible Party

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Daniela Nosch

Clinical Professor

Responsibility Role SPONSOR_INVESTIGATOR

Principal Investigators

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Daniela Nosch, PhD

Role: PRINCIPAL_INVESTIGATOR

Institute of Optometry, FHNW

Locations

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Institute of Optometry

Olten, Canton of Solothurn, Switzerland

Site Status

Countries

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Switzerland

References

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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.

Reference Type BACKGROUND
PMID: 15106930 (View on PubMed)

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.

Reference Type BACKGROUND
PMID: 10421298 (View on PubMed)

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.

Reference Type BACKGROUND
PMID: 33775377 (View on PubMed)

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.

Reference Type BACKGROUND
PMID: 12697417 (View on PubMed)

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.

Reference Type BACKGROUND
PMID: 35156726 (View on PubMed)

Other Identifiers

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2022-D0011

Identifier Type: -

Identifier Source: org_study_id

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