NCT05456061

Effect of ADDE on Tear Interferometry

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

• Status: Completed
• Phase: N/A
• Study type: Interventional
• Enrollment: 152 (actual)
• Sponsor: Yonsei University · Academic / Other
• Sex: All
• Age: 19 Years
• Healthy volunteers: Not accepted

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.

Conditions

• Tear
• Dry Eye Syndromes

Interventions

Type	Name	Description
DRUG	3% diquafosol eyedrops	Diquas® (Santen, Osaka, Japan), six times per day.
PROCEDURE	Silicone punctal plug insertion	a silicone punctal occluder (Parasol® Punctal Occluder, BVI, Waltham, Massachusetts, USA), inserted into the lower eyelid

Timeline

• Start date: 2018-08-01
• Primary completion: 2019-08-01
• Completion: 2022-01-31
• First posted: 2022-07-13
• Last updated: 2022-07-13

Locations

1 site across 1 country: South Korea