The Influence of Meibomian Gland Expression on Corneal Aberrations in MGD Patients

Sponsor
Wenzhou Medical University (Other)
Overall Status
Completed
CT.gov ID
NCT05028491
Collaborator
(none)
62
1
9.9
6.3

Study Details

Study Description

Brief Summary

To evaluate the influence of corneal-aberrations before and after the meibomian gland thermal massage treatment.

Condition or Disease Intervention/Treatment Phase

    Detailed Description

    62 MGD patients treated with meibomian gland thermal massage once a week for 3 to 4 weeks were recruited.The Ocular Surface Disease Index questionnaire; tear film assessment encompassing tear meniscus height and non-invasive keratograph breakup time ; meibography score,corneal fluorescein staining; the Schirmer I test ; expressible meibomian gland, and quality ,anterior and total corneal aberrations were evaluated before and after treatment.

    Study Design

    Study Type:
    Observational
    Actual Enrollment :
    62 participants
    Observational Model:
    Case-Only
    Time Perspective:
    Prospective
    Official Title:
    The Effect of Meibomian Gland Thermal Massage on Corneal Aberrations in Meibomian Gland Dysfunction Patients
    Actual Study Start Date :
    Oct 1, 2020
    Actual Primary Completion Date :
    Jun 29, 2021
    Actual Study Completion Date :
    Jul 29, 2021

    Outcome Measures

    Primary Outcome Measures

    1. corneal aberration corneal aberrations [baseline and 1 week after treatment]

      Corneal aberrations were measured with a Pentacam。 The anterior corneal wavefront aberration was expanded with normalized Zernike polynomials.The corneal aberration from 3rd to 6th order were recorded as the root mean square (RMS) for analysis.

    Eligibility Criteria

    Criteria

    Ages Eligible for Study:
    18 Years to 90 Years
    Sexes Eligible for Study:
    All
    Accepts Healthy Volunteers:
    No
    Inclusion Criteria:
    • tear break-up time (BUT) ≤10 seconds or Schirmer I test (SIT) ≤10 mm, the presence of dry eye symptoms, and fluorescein staining (FL) score <3 points and at least one lid margin abnormality and poor meibomian gland expressibility
    Exclusion Criteria:
    • eyelid structure abnormal(Entropion , ectropion);

    • having received any other treatment for MGD within three months

    • history of ocular surgery

    • contact lens use

    • ocular infection

    • any type of corneal scarring

    Contacts and Locations

    Locations

    Site City State Country Postal Code
    1 Eye Hospital of Wenzhou Medical College Wenzhou Zhejiang China 325027

    Sponsors and Collaborators

    • Wenzhou Medical University

    Investigators

    • Study Director: Yune Zhao, Ophthalmology and Optometry Hospital

    Study Documents (Full-Text)

    None provided.

    More Information

    Publications

    None provided.
    Responsible Party:
    Yune Zhao, Vice president of Eye Hospital of Wenzhou Medical University, Wenzhou Medical University
    ClinicalTrials.gov Identifier:
    NCT05028491
    Other Study ID Numbers:
    • hf-meibomian glands
    First Posted:
    Aug 31, 2021
    Last Update Posted:
    Sep 8, 2021
    Last Verified:
    Aug 1, 2021
    Studies a U.S. FDA-regulated Drug Product:
    No
    Studies a U.S. FDA-regulated Device Product:
    No
    Keywords provided by Yune Zhao, Vice president of Eye Hospital of Wenzhou Medical University, Wenzhou Medical University
    Additional relevant MeSH terms:

    Study Results

    No Results Posted as of Sep 8, 2021