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A Modified Calculation Formula for Meibomian Gland Grading

Sponsor
Zhongnan Hospital (Other)
Overall Status
Completed
CT.gov ID
NCT06106737
Collaborator
(none)
40
Enrollment
1
Location
1.9
Actual Duration (Months)
20.6
Patients Per Site Per Month

Study Details

Study Description

Brief Summary

The meibomian gland (MG) is a modified sebaceous gland located in the upper and lower eyelids. The grades of MG loss (i.e. meiboscore) is calculated as the ratio between the area of the MGs and the eyelids, and this calculation is based on the two-dimensional digital infrared images.In the current formula, the area of the eyelid is the denominator. However, because the eyelids need to be flipped over for the examination and evaluation, and there may be interobserver variability in the measurement of the area of the eyelids. Aging and involutional eyelid disorders, such as ptosis, ectropion, and entropion, may lead to laxity or deformation of eyelids, and impact the shape and area of eyelid area consequently.These factors could cause inaccuracy in current evaluation method, and impact the grading and evaluation of treatment efficacy of MGD, especially in self-controlled studies, such as in clinical trials.

In this study, we propose to use a modified calculation formula for the grading of MGs.we could measure the white to white (WTW) distance of cornea, and then calculate the area of cornea (i.e. corneal base area) accordingly.Unlike the eyelid, the WTW distance does not change significantly during aging or between sexes.Thus, we hypothesize that using the corneal base area as the new denominator in the formula for the grading of MG loss is a better way comparing with the conventional method.

Condition or Disease Intervention/Treatment Phase

    Study Design

    Study Type:
    Observational
    Actual Enrollment :
    40 participants
    Observational Model:
    Cohort
    Time Perspective:
    Prospective
    Official Title:
    A Modified Calculation Formula for Meibomian Gland Grading
    Actual Study Start Date :
    Apr 1, 2023
    Actual Primary Completion Date :
    Apr 1, 2023
    Actual Study Completion Date :
    May 30, 2023

    Arms and Interventions

    Arm Intervention/Treatment
    previous calculation formula
    modified calculation formula

    Outcome Measures

    Primary Outcome Measures

    1. the area of the MGs and the whole eyelids [Baseline (Once a subject has enrolled in research)]

    2. the WTW distance of the cornea [Baseline (Once a subject has enrolled in research)]

    Eligibility Criteria

    Criteria

    Ages Eligible for Study:
    18 Years to 80 Years
    Sexes Eligible for Study:
    All
    Accepts Healthy Volunteers:
    Yes
    Inclusion Criteria:
    • people aged 18 to 80
    Exclusion Criteria:
    • Exclusion criteria included contact lens wearer, history of eye surgeries, systemic health conditions affecting ocular health and those who were unable to cooperate with examinations.

    Contacts and Locations

    Locations

    Site City State Country Postal Code
    1 Zhongnan Hospital of Wuhan University Wuhan Hubei China 430071

    Sponsors and Collaborators

    • Zhongnan Hospital

    Investigators

    None specified.

    Study Documents (Full-Text)

    None provided.

    More Information

    Publications

    None provided.
    Responsible Party:
    Zhongnan Hospital
    ClinicalTrials.gov Identifier:
    NCT06106737
    Other Study ID Numbers:
    • 20231020
    First Posted:
    Oct 30, 2023
    Last Update Posted:
    Oct 30, 2023
    Last Verified:
    Oct 1, 2023
    Studies a U.S. FDA-regulated Drug Product:
    No
    Studies a U.S. FDA-regulated Device Product:
    No
    Additional relevant MeSH terms:
    Meibomian Gland Dysfunction

    Study Results

    No Results Posted as of Oct 30, 2023