A Single-Center Clinical Study to Evaluate the Efficacy a... | NCT07435142

Status Module

Description Module

Label	Type	Description	Intervention Names
A Single-Center Clinical Study	Experimental	Autologous Urine-Derived Epithelial Cells in the Treatment of Corneal Endothelial Cell Dysfunction	Biological: Autologous urinary-derived epithelial cell injection

Name	Type	Description	Arm Group Labels	Other Names
Autologous urinary-derived epithelial cell injection	Biological	Cell therapy	A Single-Center Clinical Study

Outcomes Module

Primary Outcomes

Measure	Description	Time Frame
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	6 months postoperatively

Secondary Outcomes

Measure	Description	Time Frame
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	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

Eligibility Module

Eligibility Criteria

Inclusion Criteria:

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.

Exclusion Criteria:

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.
Patients with a history of allergies to drugs prescribed during the perioperative period and postoperative observation period [anesthetics (lidocaine injection), antibiotics (ofloxacin eye drops or ointment), steroid preparations (0.1% fluorometholone eye drops, tobramycin and dexamethasone eye drops or ointment, prednisolone acetate eye drops or ointment), glaucoma medications (prostaglandin preparations, β-blockers, carbonic anhydrase inhibitors, linezolid eye drops), etc.].
Patients planning to undergo intraocular surgery during this clinical study.
Diabetic patients with poor blood glucose control (HbA1C ≥8.5%).
Patients with a history of cancer or/and with systemic autoimmune disease.
Patients with severe liver dysfunction (AST>100 IU/L or ALT>100 IU/L).
Patients with severe renal dysfunction requiring dialysis (serum creatinine ≥1.5 mg/dl).
Patients with a systolic blood pressure of ≥180 mmHg or diastolic blood pressure of ≥110 mmHg despite antihypertensive treatment.
Pregnant women, women possibly pregnant, or women planning pregnancy during this clinical study period.
Patients unable to tolerate ophthalmic surgery under local anesthesia (e.g., severe claustrophobia).
Patients who participated in other clinical trials or studies within 3 month prior to consent acquisition.
Patients deemed unsuitable for this clinical study due to comorbidities, etc.