An interventional study of eyelid support plate assisted eyelid massage and glass rod assisted eyelid massage in Dry Eye Disease (DED) and MGD-Meibomian Gland Dysfunction, sponsored by Zhongshan Ophthalmic Center, Sun Yat-sen University. Not yet recruiting at 1 site in China. Open to participants aged 18 Years to 60 Years. Per ClinicalTrials.gov, last updated 2026-06-11.
Sponsored by Zhongshan Ophthalmic Center, Sun Yat-sen University · Not applicable, Interventional, and Treatment
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
1,366 studies on the registry are indexed under Dry Eye Syndromes; 207 are open to participants now.
This study's planned enrollment of 142 is above the median of 60 across 1,129 interventional studies indexed under Dry Eye Syndromes.
Browse Dry Eye Syndromes studies →Zhongshan Ophthalmic Center, Sun Yat-sen University is the lead sponsor of 164 studies on the registry; 80 are open to participants now.
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Go through the criteria one by one — yes, no or not sure — and take the list to your doctor or the study team. Kept in this browser only.
Exclusion Criteria:
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.;
Underlined terms in the criteria open these too. Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Before you join, the study team explains what taking part involves — its purpose, what happens, the risks and possible benefits — and answers your questions, so you can decide freely. Consent is usually recorded on a form (the informed consent form, ICF) signed by you or, where the law allows, by someone legally authorised to decide for you.
You can keep asking questions during the study, you are told of new information that matters, and you can choose to leave at any time.
Able to have children. For women this usually means from the first period until menopause, unless permanently unable to through surgery; for men, unless permanently sterile. Read who the line is about — participants, women, men, or their partners.
Criteria about it usually ask for contraception during the study and for a time after it.
Ways of preventing pregnancy. “Highly effective” methods fail less than 1% of the time a year when used correctly — for example an IUD or an implant.
Criteria usually say which methods count and how long to keep using them after the last dose, sometimes for male participants too. Some studies accept a partner’s vasectomy if it was confirmed successful and that person is the participant’s only sexual partner.
A weakened immune system. It can come from an illness, such as HIV or some blood cancers, or from medicines that turn the immune system down, for example after an organ transplant or for an autoimmune disease; steroids at higher doses count.
Read whether the line is about a condition or about medicines, and which medicines and doses it means.
Anti-inflammatory medicines such as prednisone, prednisolone and dexamethasone — not the anabolic steroids used for muscle.
Studies differ in what they allow: check which steroid medicines, routes (tablets, injections, creams, inhalers, eye drops) and doses this study accepts.
Informed consent
Before you join, the study team explains what taking part involves — its purpose, what happens, the risks and possible benefits — and answers your questions, so you can decide freely. Consent is usually recorded on a form (the informed consent form, ICF) signed by you or, where the law allows, by someone legally authorised to decide for you.
You can keep asking questions during the study, you are told of new information that matters, and you can choose to leave at any time.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Reproductive potential
Able to have children. For women this usually means from the first period until menopause, unless permanently unable to through surgery; for men, unless permanently sterile. Read who the line is about — participants, women, men, or their partners.
Criteria about it usually ask for contraception during the study and for a time after it.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Contraception
Ways of preventing pregnancy. “Highly effective” methods fail less than 1% of the time a year when used correctly — for example an IUD or an implant.
Criteria usually say which methods count and how long to keep using them after the last dose, sometimes for male participants too. Some studies accept a partner’s vasectomy if it was confirmed successful and that person is the participant’s only sexual partner.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Immunosuppression
A weakened immune system. It can come from an illness, such as HIV or some blood cancers, or from medicines that turn the immune system down, for example after an organ transplant or for an autoimmune disease; steroids at higher doses count.
Read whether the line is about a condition or about medicines, and which medicines and doses it means.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Corticosteroids (steroids)
Anti-inflammatory medicines such as prednisone, prednisolone and dexamethasone — not the anabolic steroids used for muscle.
Studies differ in what they allow: check which steroid medicines, routes (tablets, injections, creams, inhalers, eye drops) and doses this study accepts.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Implement glass rod assisted eyelid massage for a total of 4 times
Procedure: glass rod assisted eyelid massage
Implement eyelid support plate assisted eyelid massage for a total of 4 times.
Procedure: 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.
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
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.
Time frame: Baseline, week 4, week 8
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),
Time frame: 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.
Time frame: Baseline, week 4, week 8
change in non-invasive lacrimal height measurement(NITMH)
Non-invasive lacrimal height measurement(NITMH)(mm) using an ocular surface analyzer (Keratography 5M, Oculus, Germany)
Time frame: Baseline, week 4, week 8
Change in meibomian gland absence status
Measurement of meibomian gland deficiency using an ocular surface analyzer (Keratography 5M, Oculus, Germany). Grading criteria for meibomian gland deficiency: 0 points (normal)=no meibomian gland deficiency, 1 point (mild)=meibomian gland deficiency ratio less than 1/3, 2 points (moderate)=meibomian gland deficiency ratio between 1/3 and 2/3, 3 points (severe)=meibomian gland deficiency ratio greater than 2/3. Determine the extent and severity of meibomian gland deficiency, calculate the sum of upper and lower eyelid grading scores for each eye, with a total score range of 0-6 points.
Time frame: Baseline, week 4, week 8
Change in lipid layer thickness (LLT)
Evaluation of lipid layer yhickness (LLT)(nm) using LipiView
Time frame: Baseline, week 4, week 8
Change in partial blink frequency
Evaluation of partial blink frequency (%) using LipiView.
Time frame: Baseline, week 4, week 8
Changes in Meibomian gland discharge ability score
Apply force to the eyeball within the range of 5 meibomian gland openings outside and in the center of the lower eyelid eyelash line, and observe the number of meibomian gland openings that can discharge meibomian gland secretions. Grading criteria: 0 points (normal)=all 5 meibomian gland openings excrete secretions, 1 point (mild)=3 or 4 meibomian gland openings excrete secretions, 2 points (moderate)=1 or 2 meibomian gland openings excrete secretions, 3 points (severe)=no meibomian gland openings excrete secretions，The higher the score, the worse the discharge ability.
Time frame: Baseline, week 4, week 8
Change in score of meibomian gland secretions
Scoring by operator based on secretion characteristics. Grading criteria:0 points (normal)=clear and transparent liquid secretion，1 point (mild)=cloudy liquid secretion，2 points (moderate)=cloudy granular secretion，3 points (severe)=thick and toothpaste like secretion.The higher the score, the worse the quality of the secretion
Time frame: Baseline, week 4, week 8
comfort scores for four sessions of eyelid massage in two groups
Use the Visual Analog Scale (VAS) to score the comfort of the operation.The scale is mainly composed of a 100mm straight line, with one end representing "completely painless" and the other end representing "the most severe pain imaginable" or "extreme pain". The score range is from 0 to 100, where 0 represents complete painlessness and 100 represents the most severe pain experienced by the patient. Patients will be asked to mark the corresponding position on this line (using an "X") to represent the intensity of pain they experienced at that time. Within 1 minute after each operation, have participants mark the corresponding position on the scale to indicate the intensity of their pain at that time, and promptly record each result.
Time frame: Baseline, week 2, week 4, week 6
Average operating time of eyelid massage (min)
Record the operating time of each eyelid massage treatment in two groups (after completing surface anesthesia, from the start of eyelid massage to the completion of squeezing the upper and lower eyelids of both eyes, each eyelid is squeezed twice), timed by the same timer, and after the timer is over, the operating time (min) is recorded after verification by two researchers.
Time frame: Baseline, week 2, week 4, week 6
Plan to share: Yes
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