Corneal endothelial cell dysfunction is usually a corneal disease caused by damage or loss of corneal endothelial cells. It is characterized by corneal edema, opacity, and subepithelial bullae, leading to pain, blurred vision, or even blindness. Conventional treatments usually involve allogeneic corneal transplantation or corneal endothelial transplantation. Anterior chamber cell transplantation is a breakthrough treatment for corneal endothelial diseases developed in recent years. Autologous urine-derived epithelial cells greatly reduce the risk of immune rejection and the use of anti-rejection drugs, avoiding reliance on and waiting for corneal donors.
Patients diagnosed with corneal endothelial cell dysfunction, including those with a history of at least one penetrating keratoplasty.
Patients aged 18 years or older and 85 years or younger at the time of informed consent acquisition (regardless of gender).
Patients with central corneal endothelial cell density below 500-800 cells/mm² or unmeasurable, as detected by corneal endothelial microscopy or confocal microscopy.
Patients who can voluntarily participate in the study and provide written informed consent.
Patients with unexplained keratoconjunctival diseases.
Patients with active corneal infections or systemic infections (e.g., positive for bacteria, fungi, HBV, HCV, or other viruses).
Patients with an intraocular pressure (IOP) of ≥30 mmHg (excluding those whose IOP can be controlled below 21 mmHg with glaucoma medications).
Patients with neovascularization observed in the angle of the anterior chamber or who have undergone treatment for neovascular glaucoma.
Single group
Autologous urinary-derived epithelial cell injection
Biological/VaccineCell therapy
Mean change in corneal endothelial cell density (cells/mm²) from baseline to 6 months postoperatively, as measured by in vivo confocal microscopy
Corneal endothelial cell density (ECD) will be measured using in vivo confocal microscopy at baseline (preoperatively) and 6 months postoperatively. The primary endpoint is the mean change in ECD from baseline to 6 months postoperatively. ECD will be reported as cells/mm², with standard deviation (SD) and 95% confidence interval (CI). Only eyes with valid ECD measurements at both time points will be included in the primary analysis
Mean change in best-corrected visual acuity (logMAR) from baseline to 6 months postoperatively, as measured by Snellen chart
Mean change in best-corrected visual acuity (logMAR) from baseline to 6 months postoperatively, as measured by Snellen chart
Proportion of eyes with improved corneal transparency (4-point scale: 0 = clear, 1 = mild haze, 2 = moderate haze, 3 = severe haze) at 6 months postoperatively, as graded by slit-lamp biomicroscopy
Corneal transparency will be graded by slit-lamp biomicroscopy at baseline and 6 months postoperatively using a 4-point scale (0 = clear, 1 = mild haze, 2 = moderate haze, 3 = severe haze). The proportion of eyes with a ≥1-grade improvement in transparency will be reported
Mean change in central corneal thickness (μm) from baseline to 6 months postoperatively, as measured by anterior segment optical coherence tomography (AS-OCT)
Central corneal thickness (CCT) will be measured using anterior segment optical coherence tomography (AS-OCT) at baseline and 6 months postoperatively. The mean change in CCT (μm) from baseline to 6 months will be reported, with standard deviation and 95% confidence interval.
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Suxia Li
Lead sponsor
Shandong Eye Hospital
Sponsor institution
