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.
Study Type
INTERVENTIONAL
Allocation
NA
Purpose
TREATMENT
Masking
NONE
Enrollment
3
Cell therapy
Shandong Eye Hospital
Jinan, Shandong, China
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
Time frame: 6 months postoperatively
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
Time frame: 6 months postoperatively
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
Time frame: 6 months postoperatively
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.
Time frame: 6 months postoperatively
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