Simple Non-cultured Endothelial Cell Therapy for Corneal Endothelial Dysfunction

Safety and Efficacy of Simple Non-cultured Endothelial Cell Injection(SNEC-I) Therapy for Corneal Endothelial Dysfunction

Assessment of safety and efficacy of cell injection therapy generated using non-cultured human corneal endothelial cells in treating corneal endothelial dysfunction

The specific aim of this clinical trial is to assess the clinical efficacy and safety outcomes of patients receiving cell injection therapy generated from non-cultured human corneal endothelial cells. Clinical assessments include postoperative visual acuity, intraocular pressure, keratometric astigmatism, spherical equivalent, endothelial cell density, anterior segment optical coherence tomography (ASOCT), contrast sensitivity, as well as any postoperative complications such as graft dislocation or primary graft failure.

Inclusion Criteria:

Patients who have mild to moderate corneal endothelial decompensation or bullous keratopathy, but with minimal corneal stromal scarring resulting from irreversible post-surgical corneal decompensation, specifically, all forms of pseudophakic or aphakic bullous keratopathy.

Exclusion Criteria:

1. Severe forms or late-stage presentation of corneal decompensation with severe corneal stromal scarring and or scarring to the DM, unsuitable for SNEC-I.
2. Patients with complex anterior segment complications precluding a successful SNEC-I procedure
3. Patients who have other forms of endothelial dystrophy, traumatic corneal decompensation, or post-inflammatory corneal decompensation
4. Post-laser iridotomy or glaucoma related corneal decompensation
5. Patients not keen to participate in the clinical trial
6. Patients who are below 21 years of age or above 80 years of age
7. Patients who are pregnant
8. Patients who are cognitively impaired
9. Patients who are prisoners
10. Patients with antibiotics/antimycotics allergies