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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
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| glass rod group | Experimental | Implement glass rod assisted eyelid massage for a total of 4 times |
|
| eyelid support plate group | Experimental | Implement eyelid support plate assisted eyelid massage for a total of 4 times. |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| eyelid support plate assisted eyelid massage | Procedure | 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. |
| 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 |
| 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 |
| Measure | Description | Time Frame |
|---|---|---|
| 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 |
Inclusion Criteria:
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).
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.
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| Name | Role | Phone | Extension | |
|---|---|---|---|---|
| Qi Fu | Contact | 86+66619334 | fuqi@gzzoc.com |
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| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Zhongshan Ophthalmology Center, Sun Yat sen University | Guangzhou | Guangdong | 510060 | China |
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| glass rod assisted eyelid massage | Procedure | 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 |
|
| 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 |
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 |
| 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 |
| ID | Term |
|---|---|
| D015352 | Dry Eye Syndromes |
| D000080343 | Meibomian Gland Dysfunction |
| ID | Term |
|---|---|
| D007766 | Lacrimal Apparatus Diseases |
| D005128 | Eye Diseases |
| D005141 | Eyelid Diseases |
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