The Effect of Eyelid Margin Debridement on Contact Lens Discomfort (NCT03311204) | Clinical Trial Compass
CompletedNot Applicable
The Effect of Eyelid Margin Debridement on Contact Lens Discomfort
Australia42 participantsStarted 2017-11-01
Plain-language summary
In this study, clinical variables related to eyelids that potentially have an effect on contact lens discomfort will be investigated such as eyelid signs and secretions, eyelid sensitivity, eyelid microbiome, Demodex infestation and tear film properties. The main aim of this study is to understand the duration of efficacy of debridement of the eyelid margin and its impact on various eyelid signs (such as lid wiper epitheliopathy, lid-parallel conjunctival folds, eyelid sensitivity, meibomian gland morphology and meibum secretions, palpebral conjunctival reaction, eyelid microbiome and Demodex infestation, tear properties (both biophysical properties such as tear volume, tear meniscus height, tear evaporation, tear osmolarity and tear breakup time; and biochemical properties that are tear lipid analysis). To observe these variables, this study employs a cross-sectional design to study the effect of treatment at three instances, that is at baseline and two follow-up visits.
Who can participate
Age range18 Years – 45 Years
SexALL
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Inclusion Criteria:
* Age of 18 years or above
* Understand their rights as a research subject
* Willing and able to sign a statement of informed consent
* Normal ocular status, defined as a minimum of 20/40 visual acuity in each eye; clear corneas without scarring, opacities, or vascularization, as determined by biomicroscopic examination
* Normal external examination
* Normal puncta without punctal plugs
* Ability to cooperate with the required procedures of diagnostic agent installation, eyelid eversion, and examination.
* Contact lens wearers who have worn lenses for at least 6 months, used contact lenses for 3 weeks before the evaluation visit and used these lenses at least four times a week. These contact lens wearers will be on daily wearing modality, where the subject is supposed to wear it for at least for 6 hours, only during the day and remove the lenses during sleep.
Exclusion Criteria:
* Any ocular or systemic disease that might influence the tear film and especially subjects with a history of episodes of epilepsy.
* Subjects with eyelid inflammation of more than grade 2 will be excluded from the study as they need therapeutic intervention.
* All conjunctival abnormalities, including pingueculae greater than 1 mm in diameter, location closer than 2 mm to the limbus, or elevated more than 0.2 mm
* All forms of conjunctivitis, including allergic conjunctivitis
* Fluorescein corneal staining of grade 2 or more, after a single installation of non-preserved fluores…