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

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

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

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.