RecruitingPhase 1NCT04319848
Safety and Efficacy of Tissue Engineered Endothelial Keratoplasty
Safety and Efficacy of Tissue Engineered Endothelial Keratoplasty (TE-EK)
Sponsor
Singapore Eye Research Institute
Enrollment
30 participants
Start Date
Dec 1, 2017
Study Type
INTERVENTIONAL
Conditions
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
Min Age: 21 YearsMax Age: 80 Years
Inclusion Criteria3
- 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 Criteria10
- 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
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Interventions
OTHERTE-EK treatment group
Transplantation of tissue-engineered endothelial graft through DSAEK procedure.
Locations(1)
View Full Details on ClinicalTrials.gov
For the most up-to-date information, visit the official listing.
NCT04319848
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