Safety and Efficacy of Tissue Engineered Endothelial Keratoplasty
Recruiting now · Phase 1
Conditions studied: Mild to Moderate Corneal Endothelial Decompensation, Bullous Keratopathy, Fuchs' Endothelial Dystrophy, Post-surgical Corneal Decompensation (Irreversible)
In brief
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).
Key facts
- Study ID
- NCT04319848
- Run by
- Singapore Eye Research Institute
- People needed
- 30
- Starts
- 2017-12-01
- Expected to finish
- 2028-06-01
- Last updated by the study team
- 2025-09-12
Who can join
Age: 21 and older, up to 80. Sex: any. Healthy volunteers: not accepted.
You may qualify if…
- 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
You may not qualify if…
- 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
Where it is running
- Singapore Eye Research Institute — Singapore, Singapore (enrolling)
Full record on ClinicalTrials.gov
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