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Study of limbal stem cell deficiency and persistent epithelial defects treated with topical insulin

Study of limbal stem cell deficiency and persistent epithelial defects treated with topical insulin

Status
Active, not recruiting
Phases
Early Phase 1
Study type
Interventional
Source
ChiCTR
Registry ID
ChiCTR2500107555
Enrollment
Unknown
Registered
2025-08-13
Start date
2025-08-15
Completion date
Unknown
Last updated
2025-08-18

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

Conditions

limbal stem cell deficiency and persistent epithelial defects

Interventions

Insulin 1IU/ML:Insulin eye drops (1IU/ML, diluted with sodium hyaluronate eye drops) eye drops will be given 4 times a day for the group, and the treatment time is 1 month.
Insulin 1IU/D:Insulin eye drops (1IU/drop, prepared diluted with sodium hyaluronate eye drops) will be given eye drops 4 times a day in the group, and the treatment time is 1 month.
Control:Sodium hyaluronate eye drops will be administered to eye drops 4 times a day for 1 month in the group.

Sponsors

Affiliated Second Hospital of Zhejiang University
Lead Sponsor

Eligibility

Sex/Gender
All
Age
18 Years to 80 Years

Inclusion criteria

Inclusion criteria: (1)Patient age >= 18 years old and = 25% and < 75%, can be non-continuous clock), and the corneal surface epithelial abnormalities (including corneal conjunctivitation, corneal epithelioid lesions, neovascular growth, or persistent corneal epithelial defects). (2) Persistent corneal epithelial damage (corneal epithelial erosion and corneal epithelial defect despite at least 2 weeks of standard drug treatment) (4)Patients give informed consent and participate voluntarily, regardless of gender. (5)Signed informed consent. (6)Patients are able to follow the doctor's instructions and follow up at the specified time. (7)We randomly selected the treatment group and the control group in a single-blind manner.

Exclusion criteria

Exclusion criteria: (1)Patients have > 75% limbal stem cell damage, corneal stromal ulcer, cicatricial conjunctival disease with reduced fornix depth, abnormal eyelid position, or incomplete eyelid closure. (2)Severe weakness of cardiovascular and renal functions, malignant tumors, various bleeding diseases, acute sensitizing diseases, high fever, hyperfebrile diseases, women's pregnancy, recovery period after heart surgery, etc. (3)Patients who are participating in other clinical studies. (4)Patients with mental disorders (5)Patients with other serious chronic diseases. (6)Pregnant or lactating women. (7)There are other eye diseases that may affect the cornea, such as history of ocular trauma, allergic keratitis, bacterial keratitis, viral keratitis, immune keratitis, trachoma, and lacrimal tract diseases. (8)Those who refuse to sign the informed consent form.

Design outcomes

Primary

MeasureTime frame
Corneal epithelial defect area;

Secondary

MeasureTime frame
Blood sugar;Intraocular pressure;

Countries

China

Contacts

Public ContactXiaodan Huang

Affiliated Second Hospital of Zhejiang University

huangxiaodan@zju.edu.cn+86 138 6746 0142

Outcome results

None listed

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