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Clinical Trials in China / NCT07633938
Starting soon Not applicable

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

NCT07633938 · tracked via the Priya Life Science China tracker
Sponsor
Zhongshan Ophthalmic Center, Sun Yat-sen University
Phase
Not applicable
Started
2026-07-01
Last updated
2026-06-11

Condition(s) studied

Dry Eye Disease (DED)MGD-Meibomian Gland Dysfunction

Investigational drug(s) / intervention(s)

eyelid support plate assisted eyelid massageglass rod assisted eyelid massage

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.

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

Study summary

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

Eligibility

Sex
ALL
Min age
18 Years
Max age
60 Years
Healthy volunteers
No
Inclusion Criteria: 1. Voluntarily participate and sign an informed consent form; 2. Age range: 18 to 60 years old; 3. Meet the diagnostic criteria for dry eye in the International Society of Tears and Ocular Surface (TFOS) Dry Eye Symposium (DEWS) II ; 4. 1/3 or more of the meibomian gland openings are blocked or the secretion characteristics of the meibomian gland are abnormal; 5. The best corrected visual acuity for each eye is ≥ 0.5; 6. Eye pressure (IOP) ≥ 5mmHg and ≤ 21mmHg per eye; 7. Women with reproductive potential agree to use reliable contraceptive methods during the study period; 8. Willing and able to complete all planned research visits and follow the guidance of the researchers. Exclusion Criteria: 1. 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); 2. 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; 3. Participation in other medical studies within 3 months prior to enrollment screening; 4. 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.; 5. Eyelid abnormalities affecting eyelid function (such as ptosis, blepharospasm, entropion, ectropion, etc.); 6. 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.); 7. Currently or previously diagnosed with glaucoma, or undergoing treatment with anti-glaucoma medications; 8. Has used any of the following ocular medications within the past 1 month: immunosuppressants, nonsteroidal anti-inflammatory drugs (NSAIDs), glucocorticoids, or perfluorohexyloctane; 9. 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; 10. During pregnancy or lactation; 11. Neurological or psychiatric disorders (moderate to severe anxiety, depression, and sleep disorders); 12. Uncontrolled ocular or systemic diseases; 13. History of epilepsy; 14. The investigator determines that the subject is not suitable for participation in this study.

Primary outcome measure(s)

Trial sites (1)

FacilityCityRegionStatus
Zhongshan Ophthalmology Center, Sun Yat sen University Guangzhou Guangdong

More Zhongshan Ophthalmic Center, Sun Yat-sen University trials in China

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Official registry record

This page summarises publicly available registry data for informational purposes — not medical advice. Eligibility is determined by each study team; patients should discuss participation with their clinician.

View NCT07633938 on ClinicalTrials.gov ↗ ← All trials in China