Quantitative Assessment of Lid Margin Vascularity Using SS-OCTA

Quantitative Assessment of Lid Margin Vascularity Using Swept-source Optical Coherence Tomographic Angiography

To explore an optimized scan technique for the detection of lid margin vasculature

Study Overview

• Status: Not yet recruiting
• Conditions: Ss-octa; Lid Margin Blood Flow Density; MGD

Detailed Description

To investigate whether the SS-OCTA tool has the potential to characterize the lid margin vascularity in MGD patients. The repeatability and validity of OCTA in assessing eyelid margin blood flow density was evaluated。

• Study Type: Observational
• Enrollment (Estimated): 150

Contacts and Locations

• Study Contact: Name: Man HU; Phone Number: 13738069080; Email: 64344308@qq.com

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: Adult; Older Adult
• Accepts Healthy Volunteers: Yes

• Sampling Method: Non-Probability Sample

Study Population

MGD or normal patients who could cooperate with dry eye evaluation and SSOCTA examination in the dry eye Clinic of the Eye Hospital of Wenzhou Medical University were enrolled.

Description

Inclusion Criteria:

The MGD patients were aged >_20 years and were diagnosed according to Chinese MGD diagnostic criteria,11 including dry eye symptoms, and at least one of the following signs: (1) poor meibum expressibility or quality; (2) at least one of eyelid margin abnormalities (lid margin irregularity, plugging of the gland orifice, vascular engorgement/telangiectasia, and anterior replacement of the mucocutaneous junction. Normal subjects were defined as adults without any dry eye symptoms and lid margin abnormality.

Exclusion Criteria:

(1) subjects with ocular diseases or conditions known to affect the anatomy of the anterior segment, such as acute ocular inflammation, a history of eyelid surgery, contact lens wear within two weeks, and/or eyelid trauma; (2) subjects with of history of systemic or topical medications that might cause ocular congestion; (3) subjects with severe systemic illness or pregnancy; and (4) subjects who were difficult to cooperate with examination, resulting the obtained images were not sufficiently clear for automatic analysis.

Study Plan

How is the study designed?

Number of groups / cohorts

3

Cohorts and Interventions

Group / Cohort
1; Mild group, the scores of both clinicians were ≤ grade 1
2; Moderate group, one doctor scored grade 2, and the other doctor scored 1~2;
3; Moderate group, one doctor scored grade 2, and the other doctor scored 1~2;

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
LMBFD	Lid margin blood flow density	Immediately after ssocta

Collaborators and Investigators

• Sponsor: Wenzhou Medical University

Study record dates

Study Major Dates

• Study Start (Estimated): October 20, 2023
• Primary Completion (Estimated): December 1, 2023
• Study Completion (Estimated): February 28, 2024

Study Registration Dates

• First Submitted: October 15, 2023
• First Submitted That Met QC Criteria: October 15, 2023
• First Posted (Actual): October 19, 2023

Study Record Updates

• Last Update Posted (Actual): October 19, 2023
• Last Update Submitted That Met QC Criteria: October 15, 2023
• Last Verified: October 1, 2023

More Information

Terms related to this study

• Other Study ID Numbers: 20230801LMBFD

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No