Ignite Creation Date:
2025-12-24 @ 12:50 PM
Ignite Modification Date:
2025-12-30 @ 6:08 AM
Study NCT ID:
NCT05456061
Status:
COMPLETED
Last Update Posted:
2022-07-13
First Post:
2022-07-03
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Effect of ADDE on Tear Interferometry
Sponsor:
Yonsei University
Organization:
Study Overview
Official Title:
Effect of Aqueous-Deficient Dry Eye on Lipid Layer Thickness Measurements
Status:
COMPLETED
Status Verified Date:
2022-07
Last Known Status:
None
Delayed Posting:
No
If Stopped, Why?:
Not Stopped
Has Expanded Access:
False
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
None
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.
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:
None
Study Oversight
Has Oversight DMC:
True
Is a FDA Regulated Drug?:
False
Is a FDA Regulated Device?:
False
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
None
Is an FDA AA801 Violation?: