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Quantitative Assessment of Lid Margin Vascularity Using SS-OCTA

Sponsor
Wenzhou Medical University (Other)
Overall Status
Not yet recruiting
CT.gov ID
NCT06091722
Collaborator
(none)
150
Enrollment
4.3
Anticipated Duration (Months)

Study Details

Study Description

Brief Summary

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

Condition or Disease Intervention/Treatment Phase

    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 Design

    Study Type:
    Observational
    Anticipated Enrollment :
    150 participants
    Observational Model:
    Case-Only
    Time Perspective:
    Cross-Sectional
    Official Title:
    Quantitative Assessment of Lid Margin Vascularity Using Swept-source Optical Coherence Tomographic Angiography
    Anticipated Study Start Date :
    Oct 20, 2023
    Anticipated Primary Completion Date :
    Dec 1, 2023
    Anticipated Study Completion Date :
    Feb 28, 2024

    Arms and Interventions

    Arm Intervention/Treatment
    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;

    Outcome Measures

    Primary Outcome Measures

    1. LMBFD [Immediately after ssocta]

      Lid margin blood flow density

    Eligibility Criteria

    Criteria

    Ages Eligible for Study:
    20 Years and Older
    Sexes Eligible for Study:
    All
    Accepts Healthy Volunteers:
    Yes
    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.

    Contacts and Locations

    Locations

    No locations specified.

    Sponsors and Collaborators

    • Wenzhou Medical University

    Investigators

    None specified.

    Study Documents (Full-Text)

    None provided.

    More Information

    Publications

    None provided.
    Responsible Party:
    Yune Zhao, Principal Investigator, Wenzhou Medical University
    ClinicalTrials.gov Identifier:
    NCT06091722
    Other Study ID Numbers:
    • 20230801LMBFD
    First Posted:
    Oct 19, 2023
    Last Update Posted:
    Oct 19, 2023
    Last Verified:
    Oct 1, 2023
    Individual Participant Data (IPD) Sharing Statement:
    No
    Plan to Share IPD:
    No
    Studies a U.S. FDA-regulated Drug Product:
    No
    Studies a U.S. FDA-regulated Device Product:
    No

    Study Results

    No Results Posted as of Oct 19, 2023