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Not yet recruiting NCT07633938

The Effect of Eyelid Support Plate Assisted Eyelid Massage on Meibomian Gland Dysfunction: a Randomized Controlled Trial

No phase Interventional Dry Eye Disease (DED) MGD-Meibomian Gland Dysfunction

For patients and families

In plain language

An automatic summary of structured registry data. It is an orientation aid, not a substitute for the official protocol or a physician assessment.

What is being studied
The protocol lists: eyelid support plate assisted eyelid massage, glass rod assisted eyelid massage.
Who it may be relevant to
Registry conditions: Dry Eye Disease (DED), MGD-Meibomian Gland Dysfunction. Basic parameters: 18 years — 60 years · All.
What needs checking
Age, condition and sex are only basic indicators. Prior treatment, laboratory values and other mandatory requirements appear in the eligibility criteria below.
Where it takes place
China
Next step
Save the trial, show it to the treating physician, and confirm current recruitment with the study center. Costs, documents and travel →

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Overview

This study aims to conduct a randomized controlled clinical trial to compare the efficacy of a new type of massage device - eyelid support plate and glass rod assisted eyelid massage in improving MGD related dry eye symptoms, and evaluate the comfort and efficiency of both treatments, providing evidence-based support for clinical work

Interventions

  • Procedure eyelid support plate assisted eyelid massage
    The participants of experimental group receive sodium hyaluronate eye drops in both eyes four times a day for 8 weeks, and receive eyelid support plate assisted eyelid massage based on the group standard of Meibomian gland massage procedure (T/GDPMAA003-2023) every two weeks for a total of four times. Follow up evaluations will be conducted at weeks 4 and 8.
  • Procedure glass rod assisted eyelid massage
    The participants of control group receive sodium hyaluronate eye drops 4 times a day for 8 weeks, and receive glass rod assisted eyelid massage based on the group standard of "Meibomian gland massage operation procedure" (T/GDPMAA003-2023) every 2 weeks, for a total of 4 times. Follow up evaluations will be conducted at weeks 4 and 8

Primary outcome measures

  • Mean change from baseline in Ocular Surface Disease Index (OSDI) score at week 8 [Time frame: Baseline, week 4, week 8]
Secondary outcome measures (2)
  • Change in first non-invasive tear film break time [Time frame: Baseline, week 4, week 8]
  • proportion of Ocular Surface Disease Index (OSDI) scores showing a change ≥10 points from baseline at week 8 [Time frame: Baseline, week 4, week 8]

Eligibility criteria

Inclusion criteria

  • Voluntarily participate and sign an informed consent form;
  • Age range: 18 to 60 years old;
  • Meet the diagnostic criteria for dry eye in the International Society of Tears and Ocular Surface (TFOS) Dry Eye Symposium (DEWS) II ;
  • 1/3 or more of the meibomian gland openings are blocked or the secretion characteristics of the meibomian gland are abnormal;
  • The best corrected visual acuity for each eye is ≥ 0.5;
  • Eye pressure (IOP) ≥ 5mmHg and ≤ 21mmHg per eye;
  • Women with reproductive potential agree to use reliable contraceptive methods during the study period;
  • Willing and able to complete all planned research visits and follow the guidance of the researchers.

Exclusion criteria

  • Contact lens use: Having used contact lenses within 14 days prior to the screening visit, or refusing to commit to discontinuing contact lens use during the study period (within the next 2 months);
  • Had undergone corneal refractive surgery (e.g., LASIK/SMILE), other corneal surgeries, cataract surgery, anti-glaucoma surgery, or fundoscopic surgery within 12 months prior to enrollment screening;
  • Participation in other medical studies within 3 months prior to enrollment screening;
  • Presence of any of the following active ocular diseases at present or within 3 months prior to screening: I) Acute allergic conjunctivitis; II) Infection (by bacteria, viruses, fungi, etc.); III) Inflammation (e.g., keratitis, retinitis).

Meningitis, choroiditis, uveitis, scleritis, etc.;

  • Eyelid abnormalities affecting eyelid function (such as ptosis, blepharospasm, entropion, ectropion, etc.);
  • Extensive ocular surface scars or conditions that may compromise ocular surface integrity (e.g., Stevens-Johnson syndrome, history of chemical burns, persistent corneal epithelial defects, history of ocular trauma, etc.);
  • Currently or previously diagnosed with glaucoma, or undergoing treatment with anti-glaucoma medications;
  • Has used any of the following ocular medications within the past 1 month: immunosuppressants, nonsteroidal anti-inflammatory drugs (NSAIDs), glucocorticoids, or perfluorohexyloctane;
  • Has received any of the following non-pharmacological treatments for dry eye within the past month: meibomian gland massage, deep eyelid margin cleansing, intense pulsed light therapy, or thermal pulsation therapy;
  • During pregnancy or lactation;
  • Neurological or psychiatric disorders (moderate to severe anxiety, depression, and sleep disorders);
  • Uncontrolled ocular or systemic diseases;
  • History of epilepsy;
  • The investigator determines that the subject is not suitable for participation in this study.

Criteria are shown verbatim from the registry (in English). Final eligibility is always assessed by the study center.

Healthy volunteers: No

Study design

Allocation
Randomized
Model
Parallel assignment
Masking
Single blind
Primary purpose
Treatment

Study locations

China · 1 center
  • Zhongshan Ophthalmology Center, Sun Yat sen University — Guangzhou

Identifiers

NCT: NCT07633938 · 2026KYPJ065

Primary sources (government registries)

View this study on ClinicalTrials.gov ↗