Corneal endothelial decompensation
Conditions
Interventions
Corneal Endothelial Decompensation Group:Intracameral Injection of Cell Suspension
Sponsors
Eye Hospital of Shandong First Medical University
Eligibility
Sex/Gender
All
Age
18 Years to 80 Years
Inclusion criteria
Inclusion criteria: (1) Patients diagnosed with corneal endothelial decompensation, including those with at least one prior history of full-thickness penetrating keratoplasty. (2) Aged 18–85 years (any gender) at the time of consent. (3) Central corneal endothelial cell density (ECD) below 500–800 cells/mm² or immeasurable, as confirmed by specular microscopy or confocal microscopy. (4) Ability to provide written informed consent for voluntary participation in the study.
Exclusion criteria
Exclusion criteria: (1) Patients with keratoconjunctival diseases of unknown etiology. (2) Patients with active corneal infections or systemic infections (e.g., bacterial, fungal, HBV, HCV, or other viral infections). (3) Patients with intraocular pressure (IOP) =30 mmHg (except those whose IOP can be controlled below 21 mmHg with glaucoma medication). (4) Poorly controlled diabetes mellitus (HbA1c =8.0%). (5) Patients with neovascularization in the angle or a history of neovascular glaucoma treatment. (6) History of allergy to perioperative/postoperative medications, including: Anesthetics (lidocaine injection); Antibiotics (ofloxacin eye drops); Steroids (0.1% betamethasone ophthalmic/otic solution, 0.1% fluorometholone eye drops, tobramycin/dexamethasone eye drops/ointment); Glaucoma medications (prostaglandin analogs, ß-blockers, acetazolamide ophthalmic suspension, brinzolamide eye drops). (7) Patients scheduled for intraocular surgery during this clinical study. (8) History of malignancy (cancer). (9) Severe hepatic dysfunction (AST or ALT >100 IU/L). (10) Severe renal dysfunction requiring dialysis or serum creatinine =1.5 mg/dL. (11) Uncontrolled hypertension (systolic BP =180 mmHg or diastolic BP =110 mmHg despite antihypertensive therapy). (12) Pregnant women, women who may be pregnant, or those planning pregnancy during the study. (13) Patients unable to tolerate ophthalmic surgery under local anesthesia (e.g., severe claustrophobia). (14) Participation in another clinical trial within 1 month prior to consent. (15) Any other condition deemed unsuitable for study participation by the investigator (e.g., significant comorbidities).
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Vision;IOP(mmHg);Corneal thickness;Corneal Endothelial Cell Density; | — |
Countries
China
Contacts
Public ContactWeiyun Shi
Eye Hospital of Shandong First Medical University
Outcome results
None listed