Dry Eye Disease (DED)NCT07633938

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

A study testing eyelid support plate assisted eyelid massage and glass rod assisted eyelid massage in people with Dry Eye Disease (DED) and MGD-Meibomian Gland Dysfunction, run by Zhongshan Ophthalmic Center, Sun Yat-sen University at 1 site in China.

Not yet recruiting

Opening soon. The study is approved but enrolment has not started yet. Sites may already take enquiries.

Sites and contacts

Official record

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Trial 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… Read more about this study

Who is it for?: Ages 18 to 60 years
Conditions the study is for: Dry Eye Disease (DED), MGD-Meibomian Gland Dysfunction
What is being tested?: eyelid support plate assisted eyelid massage and glass rod assisted eyelid massage
Type of treatment: Surgery or procedure
Could I receive a placebo?: No, everyone receives an active treatment
How many people: 142 participants
Where: 1 siteChina
Study dates: 1 Jul 2026to 1 Sep 2027
Phase: Interventional

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

Ages 18 to 60 years
All sexes
No healthy volunteers
Adult

Who may be able to join

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.

Who cannot join

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.);

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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.

Trial locations and contacts

1 site in 1 country. Contact the study team or a site near you to ask about taking part.

Qi Fu contact

86+66619334

fuqi@gzzoc.com

China1 site

Zhongshan Ophthalmology Center, Sun Yat sen University
Guangzhou, Guangdong, 510060
Bishan Tian, 86+66619334, tianbishan@gzzoc.com

Other trials in China

About this study

Conditions: Dry Eye Disease (DED), MGD-Meibomian Gland Dysfunction
Being tested: eyelid support plate assisted eyelid massage, glass rod assisted eyelid massage
Medical subject headings: Dry Eye Syndromes, Meibomian Gland Dysfunction

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

eyelid support plate assisted eyelid massageProcedure or surgery
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 massageProcedure or surgery
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 groups in NCT07633938
Study group	Role	What they receive
glass rod group	Experimental	Implement glass rod assisted eyelid massage for a total of 4 times Receives: Procedure: glass rod assisted eyelid massage
eyelid support plate group	Experimental	Implement eyelid support plate assisted eyelid massage for a total of 4 times. Receives: Procedure: eyelid support plate assisted eyelid massage

What is being measured

The primary outcome is the main question the study is designed to answer.

Mean change from baseline in Ocular Surface Disease Index (OSDI) score at week 8
The OSDI is a 12-item patient-reported outcomes questionnaire, which to provide a rapid assessment of the range of ocular surface symptoms, including symptoms related to chronic dry eye, their severity, and their impact on the patient's ability to function.Each item is rated based on the frequency of symptoms in the past week: never (0 points) → sometimes (1 point) → half the time (2 points) → most of the time (3 points) → always (4 points),total score 0-100 points.The higher the score, the more obvious the dry eye symptoms.
Measured: Baseline, week 4, week 8

Secondary outcomes (2)

Change in first non-invasive tear film break time
The time (in seconds) from the blink that evenly distributed the fluorescein to the appearance of the first tear breakup was recorded. First non-invasive tear film rupture time (NIBUTf) was measured using an ocular surface analyzer (Keratography 5M, Oculus, Germany),
Measured: Baseline, week 4, week 8
proportion of Ocular Surface Disease Index (OSDI) scores showing a change ≥10 points from baseline at week 8
The OSDI is a 12-item patient-reported outcomes questionnaire, which to provide a rapid assessment of the range of ocular surface symptoms, including symptoms related to chronic dry eye, their severity, and their impact on the patient's ability to function.Each item is rated based on the frequency of symptoms in the past week: never (0 points) → sometimes (1 point) → half the time (2 points) → most of the time (3 points) → always (4 points),total score 0-100 points.The higher the score, the more obvious the dry eye symptoms.
Measured: Baseline, week 4, week 8

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

1 Jul 20261 Sep 2027

First posted8 Jun 2026
Study start1 Jul 2026 (estimated)
Primary completion1 Jul 2027 (estimated)
Study completion1 Sep 2027 (estimated)

Resources

Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
Other trials for Dry Eye Disease (DED)Studies of the same condition, open and under way.
What the trial phases meanHow a treatment moves from first tests in people to approval.

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design

Study type: Interventional
Phase: Phase N/A
Primary purpose: Treatment
Allocation: Randomised
Intervention model: Parallel groups
Masking: Single blind
Who is masked: Outcomes assessor
Enrolment: 142 participants (estimated)

IDs, dates and publications

ClinicalTrials.gov ID: NCT07633938
Sponsor's protocol ID: 2026KYPJ065
Status last verified: May 2026
First submitted: 2 Jun 2026
Last updated: 11 Jun 2026
Results posted: No
FDA-regulated drug: No
FDA-regulated device: No
Individual data sharing: Yes

Interested in taking part?

Qi Fu

86+66619334

fuqi@gzzoc.com

Talk to your doctor first and take this page with you. Only the study team can confirm whether you can join.

Questions to ask the study team

What is the study trying to find out?
What would I need to do, and how often would I visit?
Could I receive a placebo instead of the treatment?
What are the possible risks and benefits for me?
Will it cost me anything? Are travel or time paid for?
Can I keep seeing my own doctor during the study?
What happens when the study ends?

See sites and contacts

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