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Influence of Silicone Hydrogel Extended Contact Lens Wear on Corneal Sensitivity

D

Daniela Nosch

Status

Completed

Conditions

Cornea

Treatments

Device: silicone hydrogel contact lens

Study type

Interventional

Funder types

Other

Identifiers

NCT05298917
2022-D0011

Details and patient eligibility

About

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.

Full 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.

Enrollment

30 patients

Sex

All

Ages

18+ years old

Volunteers

Accepts Healthy Volunteers

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

Trial design

Primary purpose

Other

Allocation

N/A

Interventional model

Single Group Assignment

Masking

None (Open label)

30 participants in 1 patient group

extended contact lens wear
Other group
Description:
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
Treatment:
Device: silicone hydrogel contact lens

Trial contacts and locations

1

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Data sourced from clinicaltrials.gov

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