Type 2 Diabetes Mellitus Complicating Meibomian Gland Dysfunction-Associated Dry Eye Disease
Conditions
Interventions
0.3% Sodium Hyaluronate Eye Drops Group:0.3% Sodium Hyaluronate Eye Drops
Perfluorohexyl Octane Eye Drops + 0.3% Sodium Hyaluronate Eye Drops Group:Perfluorohexyl Octane Eye Drops + 0.3% Sodium Hyaluronate Eye Drops
Perfluorohexyl Octane Eye Drops Group:Perfluorohexyl Octane Eye Drops
Sponsors
Qingdao Eye Hospital of Shandong First Medical University
Eligibility
Sex/Gender
All
Age
40 Years to 70 Years
Inclusion criteria
Inclusion criteria: 1. Voluntarily sign this informed consent form for the study and be able and willing to participate in all trial assessments and visits as instructed; 2. Aged 40–70 years (inclusive); 3. Clinically diagnosed with type 2 diabetes; 4. At least one eye with DED for 6 months; 5. OSDI >= 25; 6. BUT = 3: Determined by evaluating the secretions of the five central meibomian glands in the lower eyelid using the Korb Meibomian Gland Evaluator (TearScience). Each assessment is scored from 0 to 3, where 0 indicates normal; 1 indicates thick and yellow with white granules; 2 indicates toothpaste-like material; 3 indicates no secretion or obstruction. This generates a total possible score ranging from 0 to 15. If both eyes meet the inclusion criteria, the eye with a higher baseline CFS score will be selected for the study. 10. Patient’s HbA1c remains stable during treatment (HbA1c <= 8.5%) and there have been no significant adjustments to hypoglycemic medications in the past 3 months.
Exclusion criteria
Exclusion criteria: 1. Poor blood sugar control (HbA1c > 8.5%); 2. History of malignant tumors in the eyes or surrounding areas; 3. Underwent meibomian gland physical therapy such as steaming and massage, IPL, or LipiFlow within the past 6 months; 4. Having other systemic factors causing dry eye, such as immune system diseases like Sjögren's syndrome, Stevens-Johnson syndrome, pemphigoid, graft-versus-host disease (GVHD), various connective tissue and collagen vascular diseases, severe liver dysfunction, thyroid dysfunction, rheumatoid arthritis, vitamin A deficiency, androgen deficiency, etc.; 5. Corneal epithelial lesions secondary to external injuries, such as chemical burns, ocular burns, photokeratitis, etc.; 6. Corneal epithelial lesions caused by systemic or local drug-related factors, such as hormone replacement therapy during menopause, taking antidepressants, antihistamines, anticholinergics, antipsychotics, isotretinoin, diuretics, systemic chemotherapy drugs; or using ocular disinfectants, antiviral drugs, anti-glaucoma medications (receptor blockers, etc.) and preservative-containing eye drops or ointments; 7. Presence of the following systemic diseases: any immune deficiency, HIV infection, hepatitis B, hepatitis C, acute active hepatitis A (anti-HAV IgM positive), organ or bone marrow transplantation, or hematopoietic stem cell transplantation, etc; 8. Having any chronic major disease that the investigator believes may interfere with the study parameters, including but not limited to: severe cardiopulmonary disease, poorly controlled hypertension, severe diabetic nephropathy; abnormalities found in physical examination or laboratory tests; 9. Presence of active ocular rosacea lesions, periorbital acne, pterygium, or conjunctival masses on the ocular surface or eyelids; 10. Anatomical abnormalities of the eyelids (such as incomplete eyelid closure, entropion, or ectropion) or abnormal blinking; 11. Abnormalities found in slit-lamp and/or fundus examination that are deemed clinically significant by the investigator (including but not limited to conjunctivitis, keratitis, glaucoma, uveitis, progressive diabetic retinopathy), requiring medication or surgical treatment and considered by the investigator to potentially interfere with study results; 12. Conditions that the investigator believes may pose a significant risk to the subject, potentially confound trial results, seriously interfere with the subject’s participation in the trial (such as language barriers or illiteracy), or are not in the best interest of the subject; 13. Concurrent participation in other clinical trials during the trial or follow-up period; 14. Starting from one day before baseline and continuing throughout the treatment period, patients are prohibited from wearing contact lenses, undergoing ocular surgery or laser treatment, or using other treatments for dry eye, including artificial tears, physical therapies (such as eye masks, wet wipes, or warm compresses), systemic antibiotics (such as tetracycline), and therapeutic oral supplements.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Ocular Surface Disease Index score; | — |
Secondary
| Measure | Time frame |
|---|---|
| Standard Patient Evaluation of Eye Dryness;Quality of Life Questionnaire;Corneal Fluorescein Staining;Non-Invasive First Tear Break-up Time;Lipid Layer Thickness; | — |
Countries
China
Contacts
Public ContactYanling Dong
Qingdao Eye Hospital of Shandong First Medical University
Outcome results
None listed