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

Study Overview

• Status: Not yet recruiting
• Conditions: Dry Eye Disease (DED); MGD-Meibomian Gland Dysfunction
• Intervention / Treatment: Procedure: glass rod assisted eyelid massage; Procedure: eyelid support plate assisted eyelid massage

• Study Type: Interventional
• Enrollment (Estimated): 142
• Phase: Not Applicable

Contacts and Locations

• Study Contact: Name: Qi Fu; Phone Number: 86+66619334; Email: fuqi@gzzoc.com

Study Locations

• China
  • Guangdong
    • Guangzhou, Guangdong, China, 510060
      • Zhongshan Ophthalmology Center, Sun Yat sen University
      • Contact: Bishan Tian; Phone Number: 86+66619334; Email: tianbishan@gzzoc.com

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: Adult
• Accepts Healthy Volunteers: No

Description

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.

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: Single

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: glass rod group; Implement glass rod assisted eyelid massage for a total of 4 times	Procedure: 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
Experimental: eyelid support plate group; 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.

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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.	Baseline, week 4, week 8

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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),	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.	Baseline, week 4, week 8

Other Outcome Measures

Outcome Measure	Measure Description	Time Frame
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.	Baseline, week 2, week 4, week 6
change in non-invasive lacrimal height measurement(NITMH)	Non-invasive lacrimal height measurement(NITMH)(mm) using an ocular surface analyzer (Keratography 5M, Oculus, Germany)	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.	Baseline, week 4, week 8
Change in lipid layer thickness (LLT)	Evaluation of lipid layer yhickness (LLT)(nm) using LipiView	Baseline, week 4, week 8
Change in partial blink frequency	Evaluation of partial blink frequency (%) using LipiView.	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.	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	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.	Baseline, week 2, week 4, week 6

Collaborators and Investigators

• Sponsor: Zhongshan Ophthalmic Center, Sun Yat-sen University

Study record dates

Study Major Dates

• Study Start (Estimated): July 1, 2026
• Primary Completion (Estimated): July 1, 2027
• Study Completion (Estimated): September 1, 2027

Study Registration Dates

• First Submitted: June 2, 2026
• First Submitted That Met QC Criteria: June 2, 2026
• First Posted (Actual): June 8, 2026

Study Record Updates

• Last Update Posted (Actual): June 11, 2026
• Last Update Submitted That Met QC Criteria: June 8, 2026
• Last Verified: May 1, 2026

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Eye Diseases; Lacrimal Apparatus Diseases; Eyelid Diseases; Meibomian Gland Dysfunction; Dry Eye Syndromes
• Other Study ID Numbers: 2026KYPJ065

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: YES

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No