Effect of ADDE on Tear Interferometry

Not Applicable

Completed

• Conditions: Tear; Dry Eye Syndromes
• Interventions: Drug: 3% diquafosol eyedrops; Procedure: Silicone punctal plug insertion

• Registration Number: NCT05456061
• Lead Sponsor: Yonsei University

Brief 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.

Detailed Description

Not available

Study Timeline

• Study Start: 2018-08-01
• Primary Completion: 2019-08-01
• Study Completion: 2022-01-31
• Status Verified: 2022-07
• Study First Submitted: 2022-07-03
• Study First Submitted QC: 2022-07-07
• Last Update Submitted: 2022-07-07
• Study First Posted: 2022-07-13
• Last Update Posted: 2022-07-13

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 152

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.

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Group 2	3% diquafosol eyedrops	3% diquafosol eye drops 6 times / day
Group 3	Silicone punctal plug insertion	Punctal plug insertion, lower eyelid
Group 4	3% diquafosol eyedrops	3% diquafosol eye drops 6 times / day + Punctal plug insertion, lower eyelid
Group 4	Silicone punctal plug insertion	3% diquafosol eye drops 6 times / day + Punctal plug insertion, lower eyelid

Primary Outcome Measures

Name	Time	Method
Average LLT (LLTave)	Baseline and one month after 1 month of treatments	LLT was measured using the LipiView® II tear interferometer (Johnson \& Johnson, New Brunswick, New Jersey, USA). The tear interferometer automatically records 20-second videos reflecting the TFLL on the inferior cornea. Simultaneously, the quantified LLT is measured over time in the interferometric color unit (ICU). One ICU corresponds to approximately 1 nm of LLT. The LipiView® II interferometer provides the average, maximum, and minimum LLT values. The average LLT (LLTave) reflects the LLT value at the stable phase of the TFLL spreading or equilibrium state.

Trial Locations

Locations (1)

Severance Hospital, Yonsei University College of Medicine; 🇰🇷 Seoul, Korea, Republic of