Diabetes-related dry eye
Conditions
Interventions
Control Eye Drop Group (Sodium Hyaluronate Eye Drop Group):The control group is administered sodium hyaluronate eye drops, a routine clinical medication, for basal ocular surface lubrication therapy i
Insulin Eye Drop Group :The experimental group is administered insulin eye drops (formulated by combining marketed recombinant human insulin injection with marketed sodium hyaluronate eye drops) for o
Sponsors
Tianjin Medical University General Hospital
Eligibility
Sex/Gender
All
Age
18 Years to 80 Years
Inclusion criteria
Inclusion criteria: Inclusion Criteria for Patients with Diabetic Dry Eye Disease (DDED) 1: Age: 18 to 80 years old. 2: Clinical Status: Diagnosed with clinical-stage diabetes and non-proliferative diabetic retinopathy (NPDR), with no history of ophthalmic surgery within the past 6 months. 3: Severe Dry Eye Criteria: Fluorescein tear break-up time (FBUT) <= 5 s, or Schirmer I test result without topical anesthesia <= 5 mm/5 min, accompanied by at least one ocular subjective symptom such as dryness, foreign body sensation, burning sensation, fatigue, discomfort, or fluctuating vision. 4: Mild-to-Moderate Dry Eye Criteria: 5 s < FBUT <= 10 s, or Schirmer I test result without topical anesthesia 5 mm/5 min < Schirmer I <= 10 mm/5 min, accompanied by at least one ocular subjective symptom (dryness, foreign body sensation, burning sensation, fatigue, discomfort, or fluctuating vision), along with positive corneal and conjunctival fluorescein staining. 5. Absence of various dry eye conditions and other ocular surface diseases caused by chronic dacryocystitis, blepharitis, allergic conjunctivitis, keratitis, corneal scarring, etc. 6. Absence of eyelid diseases such as ectropion, entropion, trichiasis, and ptosis. 7. Absence of conjunctival diseases such as conjunctivochalasis and pterygium.
Exclusion criteria
Exclusion criteria: Exclusion Criteria for Patients with Diabetic Dry Eye Disease (DDED) 1. Patients with Sjögren's syndrome or other autoimmune diseases. 2. Patients currently using eye drops for ocular diseases (including dry eye), or using glaucoma medications and unable to discontinue therapy for 1 month prior to the study. 3. History of ocular trauma or chemical eye injury. 4. History of wearing contact lenses within the past 1 month.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Fluorescein tear break up time;Corneal fluorescein staining score;Schirmer I test results;Ocular Surface Disease Index (OSDI) score; | — |
Countries
China
Contacts
Public ContactHua Yan
Tianjin Medical University General Hospital
Outcome results
None listed