TE-EK treatment group: Transplantation of tissue-engineered endothelial graft through DSAEK procedure.
Study summary
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
Sex
ALL
Min age
21 Years
Max age
80 Years
Healthy volunteers
No
Inclusion Criteria:
Patients who have mild to moderate corneal endothelial decompensation or bullous keratopathy, but with minimal corneal stromal scarring resulting from a variety of conditions including:
* Fuchs' endothelial dystrophy
* Post-surgical corneal decompensation (irreversible) - all forms of pseudophakic or aphakic bullous keratopathy
Exclusion Criteria:
* 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
* Patients not keen to participate in the clinical trial
* Patients who are below 21 years of age or above 80 years of age
* Patients who are pregnant
* Patients who are cognitively impaired
* Patients who are prisoners
* Patients who are allergic to antibiotics
Primary outcome measure(s)
(BSCVA) — 3 months BSCVA will be converted to logarithm of the minimum angle of resolution (logMAR) visual acuity for statistical analysis.
Trial sites (1)
Facility
City
Region
Status
Singapore Eye Research Institute
Singapore
Singapore
Recruiting
More Singapore Eye Research Institute trials in Singapore
This page summarises publicly available registry data for informational purposes — not medical advice. Eligibility is determined by each study team; patients should discuss participation with their clinician.
We use cookies to analyse site traffic and improve your experience. With your consent, we may also use cookies for advertising. You can change your choice at any time.