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Clinical Efficacy and Immunoregulatory Mechanisms of Minimally Invasive Corneal Neurotization (MICN) for Neurotrophic Keratopathy (NK): A Disease-Specific Cohort Study

Clinical Efficacy and Immunoregulatory Mechanisms of Minimally Invasive Corneal Neurotization (MICN) for Neurotrophic Keratopathy (NK): A Disease-Specific Cohort Study

Status
Active, not recruiting
Phases
Unknown
Study type
Observational
Source
ChiCTR
Registry ID
ChiCTR2500114693
Enrollment
Unknown
Registered
2025-12-16
Start date
2025-12-31
Completion date
Unknown
Last updated
2026-01-05

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

Conditions

Neurotrophic keratopathy

Interventions

Observation group:None

Sponsors

Shanghai Ninth People's Hospital, Shanghai JiaoTong University School of Medicine
Lead Sponsor

Eligibility

Sex/Gender
All

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

MeasureTime frame
Corneal Nerve Fiber Density, CNFD;Corneal sensation recovery;

Secondary

MeasureTime 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

Public ContactJin Li

Shanghai Ninth People's Hospital, Shanghai JiaoTong University School of Medicine

lijinabcd@sina.cn+86 15618877086

Outcome results

None listed

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