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Effect of ADDE on Tear Interferometry

Effect of Aqueous-Deficient Dry Eye on Lipid Layer Thickness Measurements

NCT05456061•Yonsei University

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.

Eligibility

Age

19 - No limit years

Sex

ALL

Healthy Volunteers

Inclusion Criteria

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

Exclusion Criteria

•1. 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.
•2. 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.
•3. any medical/surgical history related to tear production and tear function except that in the study protocol were excluded.
•4. Hypersecretory meibomian gland dysfunction (MGD)
•* When both eyes of a patient could be included, an eye with the lower TMH was selected.

Locations (1)

Severance Hospital, Yonsei University College of Medicine

Seoul, South Korea

Key Dates

Start Date

August 1, 2018

Primary Completion Date

August 1, 2019

Completion Date

January 31, 2022

Last Updated

July 13, 2022

Enrollment

152

ACTUAL participants

Conditions

TearDry Eye Syndromes

Interventions

3% diquafosol eyedrops

DRUG

Silicone punctal plug insertion

PROCEDURE

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RECRUITINGPHASE1/PHASE2

Tuberoplasty Versus Balloon Spacer

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Rotator Cuff Tears

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RECRUITINGPHASE3

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Data Source & Attribution

This clinical trial information is sourced from ClinicalTrials.gov, a service of the U.S. National Institutes of Health.

ClinicalTrials.gov last update: July 13, 2022Data synced to Clareo: March 29, 2026

Modifications: This data has been reformatted for display purposes. Eligibility criteria have been parsed into inclusion/exclusion sections. Location data has been geocoded to enable distance-based search. For the authoritative and most current information, please visit ClinicalTrials.gov.

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Effect of ADDE on Tear Interferometry

Inclusion Criteria

Exclusion Criteria

Sex Hormone Supplementation and Rotator Cuff Repair: A Preliminary Randomized Trial

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FiberLocker® System Augmentation of Rotator Cuff Repairs

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