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A Modified Calculation Formula for Meibomian Gland Grading

A Modified Calculation Formula for Meibomian Gland Grading

Status
Completed
Phases
Unknown
Study type
Observational
Source
ClinicalTrials.gov
Registry ID
NCT06106737
Enrollment
40
Registered
2023-10-30
Start date
2023-04-01
Completion date
2023-05-30
Last updated
2023-12-06

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Meibomian Gland Dysfunction

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, the investigators propose to use a modified calculation formula for the grading of MGs. The investigators 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, the investigators 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.

Interventions

None listed

Sponsors

Zhongnan Hospital
Lead SponsorOTHER

Study design

Observational model
COHORT
Time perspective
PROSPECTIVE

Eligibility

Sex/Gender
ALL
Age
18 Years to 80 Years
Healthy volunteers
Yes

Inclusion criteria

* people aged 18 to 80

Exclusion criteria

*

Design outcomes

Primary

MeasureTime frame
the area of the MGs and the whole eyelidsBaseline (Once a subject has enrolled in research)
the WTW distance of the corneaBaseline (Once a subject has enrolled in research)

Countries

China

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026