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A Single-Center, Open-Label, Single-Arm, Exploratory Clinical Study to Evaluate the Safety and Efficacy of Anterior Chamber Injection of Nicotinamide in Patients with Corneal Endothelial Decompensation

Clinical Study on Nicotinamide for the Treatment of Corneal Endothelial Dysfunction

Status
Active, not recruiting
Phases
Early Phase 1
Study type
Interventional
Source
ChiCTR
Registry ID
ChiCTR2500114086
Enrollment
Unknown
Registered
2025-12-08
Start date
2025-12-15
Completion date
Unknown
Last updated
2025-12-15

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

Conditions

Corneal endothelial cell dysfunction

Interventions

Medication group:Anterior Chamber Perfusion of Nicotinamide

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: Aged 18 years or older. Clinically diagnosed with critical stage of corneal endothelial decompensation, accompanied by persistent corneal edema. For the study eye, central corneal thickness (CCT) is >= 620 µm or thicker than the contralateral healthy eye by > 50 µm. Best corrected visual acuity (BCVA) of the study eye ranges from hand motion to 0.5 (decimal visual acuity chart). Voluntarily sign the informed consent form.

Exclusion criteria

Exclusion criteria: Presence of active ocular surface or intraocular infection/inflammation in the study eye. Complicated with severe glaucoma or active fundus lesions. The study eye is aphakic or has unstable factors such as lax zonular ligaments. Allergy to NAM or any components in the preparation. Pregnant or lactating women. Any uncontrolled systemic diseases. Those unable to attend follow-up visits on time.

Design outcomes

Primary

MeasureTime frame
Corneal thickness;

Secondary

MeasureTime frame
Corneal Endothelial Cell Density;Xin Vaule;BCVA;

Countries

China

Contacts

Public ContactCheng Jun

Qingdao Eye Hospital of Shandong First Medical University

alice.567@163.com+86 186 5328 0868

Outcome results

None listed

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