The Effect of Eyelid Support Plate Assisted Eyelid Massage on Meibomian Gland Dysfunction: a Rand… (NCT07633938) | Clinical Trial Compass
Not Yet RecruitingNot Applicable
The Effect of Eyelid Support Plate Assisted Eyelid Massage on Meibomian Gland Dysfunction: a Randomized Controlled Trial
China142 participantsStarted 2026-07-01
Plain-language 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
Who can participate
Age range
18 Years – 60 Years
Sex
ALL
See this in plain English?
AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.
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;
Questions worth asking your doctor
Bring these to your next appointment. They're a starting point for a shared conversation — not a sign you qualify or a recommendation to enrol.
1This trial involves a device called an eyelid support plate to assist with eyelid massage for meibomian gland dysfunction — how does this approach compare to the standard warm compress and eyelid massage routine I might already be doing or could start right away?
2Since this trial isn't recruiting yet, how long might it realistically be before I could even be considered for enrollment, and is waiting a reasonable option given where my dry eye symptoms are right now?
3The trial is measuring improvement in OSDI scores over 8 weeks — is 8 weeks long enough to know whether my meibomian gland dysfunction is actually responding to a treatment, or would I need to think longer-term?
4Because this is listed as Phase NA, which often applies to device or behavioral studies rather than drug trials, what do we know so far about the safety of using an eyelid support plate during eyelid massage, and are there any risks specific to my eye health I should be aware of?
5Are there already established treatments for meibomian gland dysfunction — like thermal pulsation therapy or prescription eye drops — that might be worth trying first while this trial is still in the pre-recruitment stage?
Generated to help you prepare — always confirm anything about your own eligibility and care with the study team and your doctor.
Questions for the trial coordinator
The trial coordinator is the person who runs the study day to day. These cover the practical side — logistics, costs, and what taking part would actually mean for your life. The study team confirms whether you meet the criteria; these are questions to ask, not a sign you qualify.
1What does taking part actually involve week to week — how many visits, where, and how long does each one take?
2What costs are covered by the study, and what might I have to pay for myself, including travel, parking, or time off work?
3What happens during screening, and what happens if the study team confirms I don't meet the criteria after those tests?
4Who pays for the scans, blood work, and other tests the trial requires — the study, my insurance, or me?
5How will being in the trial affect my regular care, and will my own doctor stay informed and involved?
6Can I leave the trial at any point if I change my mind, and what would happen to my care if I do?
A starting point for the conversation — always confirm anything about your own eligibility, costs, and care with the study team and your doctor.
What they're measuring
1
Mean change from baseline in Ocular Surface Disease Index (OSDI) score at week 8
Timeframe: Baseline, week 4, week 8
Trial details
NCT IDNCT07633938
SponsorZhongshan Ophthalmic Center, Sun Yat-sen University
. 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).
. 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;