Dry Eye
Conditions
Interventions
Experimental group:Wear new composite frames
Control group:Wear test glasses with black frames
Sponsors
Beijing Tongren Hospital, Capital Medical University
Eligibility
Sex/Gender
All
Age
18 Years to 100 Years
Inclusion criteria
Inclusion criteria: To be enrolled in this study, patients must meet all of the following inclusion criteria at both screening and randomization: 1. Age >=18 years old; 2. Signed written informed consent; 3. At the time of the screening visit (visit 0), the patient had complained of dry eye symptoms for at least 6 months; 4. If artificial tears were used to relieve dry eye symptoms within 30 days prior to use of the device, stop using them 72 hours before use; 5. At interview 0 and interview 1, OSDI score >=13; 6. During interview 0 and interview 1, tear film rupture time (BUT) =5 mm under non-anesthetic state; 8. When visiting 0 and 1, MGD total score >=3; Meibomian gland dysfunction (MGD) scoring criteria: The secretion of 5 central glands of the lower eyelid was assessed, with a score of 0-3 for each gland; 0= normal, 1= thick/yellow, white, granular; 2= mushy; 3= none/block; Total score 0-15 points; 9. At the time of visit 0 and visit 1, at least one eye (the same eye) meets all conditions of 5, 6, 7 and 8 above; 10. Are not using any treatment devices or medications known to cause dry eye.
Exclusion criteria
Exclusion criteria: Exclusion criteria 1. Patients with any of the following conditions during screening and random visit will not be considered as enrolled cases: 2. Pregnant or lactating women or those who have a family plan in the near future; 3. suffering from other eye diseases; 4. Tear film rupture time =0 seconds, or tear secretion experiment =0 mm /5 minutes; 5. The total corneal staining number is greater than 30 points, there are flaky coloring fusion or filamentous objects; 6. Severe MGD patients (grade 4); 7. Patients who have received any type of dry eye or MGD physical therapy in the past 12 months, including but not limited to IPL, iLux, and Lipiflow; 8. Hot massage or hot compress treatment within 2 weeks before enrollment; 9. Eyelid surface abnormalities (such as entropion, ectropion, tumor, edema, blepharospasm, eyelid insufficiency, severe trichiasis, and severe ptosis) affect the eyelid function of both eyes; 10. Patients with lacrimal embolism or lacrimal occlusion; 11. Complicated with serious primary disease of heart, cerebrovascular, liver, kidney and hematopoietic system; 12. Internal eye surgery or external eye injury within the last six months; 13. Patients who could not stop wearing contact lenses during the trial; 14. Long-term systemic or ocular medication may affect patients evaluated in the study; 15. It is not possible to guarantee the use of equipment and visitors as required during the test; 16. Sjogren's syndrome, systemic diseases, and other eye diseases that affect the evaluation of efficacy; 17. Have used other research equipment or drugs in the past month; 18. Those who have any reasons that the researcher deems unsuitable for participating in the experi
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Non-invasive tear breakup time (NITBUT);Eye dryness (EDS) score; | — |
Secondary
| Measure | Time frame |
|---|---|
| Tear film lipid layer thickness (LLT);Corneal fluorescein staining (CFS);Non-contact intraocular pressure;Best-corrected visual acuity (BCVA, logMAR);Meibomian gland score (MGS); | — |
Countries
China
Contacts
Public ContactTian Lei
Beijing Tongren Hospital, Capital Medical University
Outcome results
None listed