Neurotrophic keratopathy
Conditions
Interventions
Sponsors
Eligibility
Inclusion criteria
Inclusion criteria: 1. Diagnosed with NK (meeting the clinical staging (I-III) according to the International NK Diagnosis and Treatment Consensus, 2020 edition); 2. Presence of decreased corneal sensation (Cochet-Bonnet = 20mm) or corneal nerve fiber damage (IVCM-detected CNFD <= 8.5 mm/mm^2); 3. No severe systemic autoimmune diseases or history of corneal infections; 4. Signed informed consent and able to comply with an 18-month postoperative follow-up.
Exclusion criteria
Exclusion criteria: 1. Mixed diseases: Coexisting systemic neurological/immune diseases such as diabetic peripheral neuropathy or Sjögren's syndrome. 2. Ocular contraindications: Active corneal infection, glaucoma, history of corneal transplantation or refractive surgery. 3. Interfering factors: Pregnancy or breastfeeding, long-term use of immunosuppressants/neurotrophic drugs (such as NGF preparations). 4. Poor compliance: Unable to attend regular follow-up visits or complete examinations (e.g., severe cognitive impairment).
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Corneal Nerve Fiber Density, CNFD;Corneal sensation recovery; | — |
Secondary
| Measure | Time frame |
|---|---|
| Best Corrected Visual Acuity (BCVA);Corneal Epithelial Integrity Recovery Rate;Time of appearance of Tinel sign;Improvement of neural density distribution in five quadrants;Number of neuromas reduced by >=50% under confocal microscopy; | — |
Countries
China
Contacts
Shanghai Ninth People's Hospital, Shanghai JiaoTong University School of Medicine