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
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;
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).
Parallel
eyelid support plate assisted eyelid massage
Procedure/SurgeryThe 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 massage
Procedure/SurgeryThe 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.
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),
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.
change in non-invasive lacrimal height measurement(NITMH)
Non-invasive lacrimal height measurement(NITMH)(mm) using an ocular surface analyzer (Keratography 5M, Oculus, Germany)
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.
Change in lipid layer thickness (LLT)
Evaluation of lipid layer yhickness (LLT)(nm) using LipiView
Change in partial blink frequency
Evaluation of partial blink frequency (%) using LipiView.
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