About this trial
Assessment of safety and efficacy of tissue-engineered corneal endothelial graft material generated using cultured human corneal endothelial cells for tissue-engineered endothelial keratoplasty (TE-EK).
Eligibility criteria
Qualifiers
Fuchs' endothelial dystrophy
Post-surgical corneal decompensation (irreversible) - all forms of pseudophakic or aphakic bullous keratopathy
Disqualifiers
Severe forms or late stage presentation of corneal decompensation with severe corneal stromal scarring, unsuitable for TE-EK surgery as opposed to penetrating keratoplasty
Patients with complex anterior segment complications precluding a successful TE-EK procedure
Patients who have other forms of endothelial dystrophy, traumatic corneal decompensation, or post-inflammatory corneal decompensation
Post-laser iridotomy or glaucoma related corneal decompensation
Trial design
Treatments tested in this trial
- TE-EK treatment group