CompletedNot Applicable

Effect of ADDE on Tear Interferometry

South Korea152 participantsStarted 2018-08-01

Plain-language summary

Importance: Lipid layer thickness (LLT) reflects the lipid components of tear film, but is affected by the mucocutaneous components. This study investigated the therapeutic effect of the treatments for aqueous-deficient dry eye (ADDE) on LLT. Objective: To investigate the effect of ADDE and its treatments on LLT measurements by tear interferometry. Design, Setting, and Participants: This prospective comparative interventional study included 152 eyes from 152 patients with ADDE. Interventions: Participants were classified into four groups: control group (Group 1), 3% diquafosol group (Group 2), punctal plug insertion group (Group 3), and combined treatment group (Group 4). Main Outcomes and Measures: Average LLT (LLTave) was measured using a LipiView® II tear interferometer at baseline and one month after treatments.

Who can participate

Age range19 Years

SexALL

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Inclusion criteria

✓. presence of one or more subjective symptoms of DED, including eye dryness, foreign body sensation, irritation, burning, blurred vision, and pain.
✓. tear meniscus height (TMH) of \<200 µm for aqueous deficiency measured using Keratograph 5M® (Oculus Optikgeräte GmbH, Wetzlar, Germany).
✓. evidence of corneal and/or conjunctival damage on slit-lamp biomicroscopy with fluorescein staining.

Exclusion criteria

✕. acute and chronic ocular surface diseases that affect DED, including infection, allergy, and autoimmune disease, and that interfere with tear interferometric measurements, such as corneal opacity and pterygium, were excluded.
✕. a history of the use of contact lens, known systemic diseases such as Sjögren's syndrome, Stevens-Johnson syndrome, and ocular graft-versus-host disease.
✕. any medical/surgical history related to tear production and tear function except that in the study protocol were excluded.
✕. Hypersecretory meibomian gland dysfunction (MGD)

What they're measuring

Average LLT (LLTave)

Timeframe: Baseline and one month after 1 month of treatments

Trial details

NCT IDNCT05456061

SponsorYonsei University

Sponsor typeOTHER

Study typeINTERVENTIONAL

Primary completion2019-08-01

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