Meibomian gland dysfunction related dry eye
Conditions
Interventions
Single Liquid Pulsation System Treatment Group:A single 12-minute Tearmaestro liquid pulsation treatment (TEARMAESTRO-1000 console, Liquid-1000 applicator, 42.5°C).
Sponsors
Tianjin Medical University Eye Hospital
Eligibility
Sex/Gender
All
Age
24 Years to 54 Years
Inclusion criteria
Inclusion criteria: 1. Voluntarily participate in and sign the informed consent; 2. Age 18–60 years, regardless of gender; 3. Meet the diagnostic criteria for dry eye (Chinese Expert Consensus on Dry Eye: Definition and Classification (2020)): OSDI >= 13 and BUT <= 5 s, or 5 s < BUT <= 10 s accompanied by positive corneal and conjunctival fluorescein staining; 4. Meet the diagnostic criteria for meibomian gland dysfunction (Chinese Expert Consensus on Meibomian Gland Dysfunction: Definition and Classification (2023)): presence of abnormal meibomian gland opening (obstruction, stenosis, etc.) and/or abnormal meibomian gland secretion (abnormal expressibility or secretion consistency); 5. Have discontinued use of artificial tears within 72 hours prior to screening and agree to refrain from using them during the study period.
Exclusion criteria
Exclusion criteria: 1. Active eye infection or inflammation in both eyes at the time of screening; 2. Suffering from diseases that seriously affect the stability of the ocular surface (such as eyelid ectropion, severe conjunctival relaxation, pterygium, corneal ulcer, etc.); 3. Wearing contact lenses or receiving eye surgery or ocular trauma within 3 months before screening; 4. Have uncontrolled severe systemic diseases (such as poorly controlled diabetes, autoimmune diseases, etc.), or are using drugs that may affect tear secretion (such as anticholinergic drugs, some antidepressants); 5. Participated in other drug or device clinical trials within 30 days before screening; 6. Known allergy to the diagnostic dye used in the study, such as sodium fluorescein; 7. Any other circumstances that the investigator considered inappropriate for participation in the study.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Corneal Fluorescein Staining (CFS) Score; | — |
Secondary
| Measure | Time frame |
|---|---|
| Lipid Layer Thickness (LLT);Tear Meniscus Height (TMH);Best-Corrected Visual Acuity (BCVA);Partial Blink Rate;Non-Contact Intraocular Pressure (IOP);Meibomian Gland Orifice Score (MQS);Marx‘s Line Grade;Meibomian Gland Secretion Score (MGS);Change in Ocular Surface Disease Index (OSDI) Score;Schirmer I Test;Tear Film Break-up Time (TBUT);Incidence of Adverse Events;Meibomian Gland Imaging (for morphological scoring); | — |
Countries
China
Contacts
Public ContactShaozhen Zhao
Tianjin Medical University Eye Hospital
Outcome results
None listed