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

Обзор

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

Вмешательства

• Процедура 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.
• Процедура 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

Первичные конечные точки

• Mean change from baseline in Ocular Surface Disease Index (OSDI) score at week 8 [Срок оценки: Baseline, week 4, week 8]

Вторичные конечные точки (2)

• Change in first non-invasive tear film break time [Срок оценки: Baseline, week 4, week 8]
• proportion of Ocular Surface Disease Index (OSDI) scores showing a change ≥10 points from baseline at week 8 [Срок оценки: Baseline, week 4, week 8]

Критерии участия

Критерии включения

• 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.

Критерии исключения

• 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.

Критерии приведены из реестра в оригинале (на английском). Окончательную оценку соответствия проводит исследовательский центр.

Здоровые добровольцы: Нет

Дизайн исследования

Распределение

Рандомизированное

Модель

Параллельные группы

Маскирование

Простое слепое

Основная цель

Лечение

Центры проведения

Китай · 1 центр

• Zhongshan Ophthalmology Center, Sun Yat sen University — Гуанчжоу

Идентификаторы

NCT: NCT07633938 · 2026KYPJ065

Первоисточники (государственные реестры)

• ClinicalTrials.gov (NIH, США)

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