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Clinical study on the correlation analysis of diabetic ocular surface lesions

Clinical study on the correlation analysis of diabetic ocular surface lesions

Status
Recruiting
Phases
Unknown
Study type
Observational
Source
ChiCTR
Registry ID
ChiCTR2200058930
Enrollment
Unknown
Registered
2022-04-20
Start date
2020-01-01
Completion date
Unknown
Last updated
2024-01-28

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Diabetic keratopathy

Interventions

Diabetic group:Ocular surface examination

Sponsors

Qingdao Eye Hospital of Shandong First Medical University
Lead Sponsor

Eligibility

Sex/Gender
All
Age
18 Years to 90 Years

Inclusion criteria

Inclusion criteria: 1. Aged > 18 years; 2. Able and willing to cooperate with the inspection process; 3. Clinical diagnosis of type 2 diabetes mellitus; 4. Complained of eye discomfort symptoms: dryness, foreign body sensation, burning sensation or pain, accompanied by photophobia, tears or vision loss; 5. Corneal fluorescein staining showed epithelial integrity or spot staining; 6. Tear film rupture time BUT < 10 s; 7. Tear secretion test Schirmer I<=10mm; 8. Confocal microscopy showed decreased corneal nerve density; 9. Corneal sensitivity with or without reduction.

Exclusion criteria

Exclusion criteria: 1. Corneal epithelial defect; 2. Corneal ulcer, stromal scar and corneal surgery history, etc.; 3. Glaucoma combined with poor control of intraocular pressure; 4. Wear contact lenses for a long time; 5. History of eye trauma; 6. History of corneal refractive surgery; 7. Long-term use of eye drops or ointment; 8. History of autoimmune diseases (such as Sjogren's syndrome, rheumatoid arthritis, ankylosing spondylitis, etc.).

Design outcomes

Primary

MeasureTime frame
Corneal nerve density;Corneal sensitivity;Corneal epithelial staining score;

Secondary

MeasureTime frame
Shirmer test I;Tear film rupture time;Ocular surface disease index;Anterior segment tomography;Corneal endothelial cell density;Meibomian glands score;Glycosylated hemoglobin;

Countries

China

Contacts

Public ContactZhang Yangyang

Qingdao Eye Hospital of Shandong First Medical University

fff993541@163.com+86 18866255751

Outcome results

None listed

Source: ChiCTR (via WHO ICTRP) · Data processed: Feb 4, 2026