Status:
RECRUITING
Safety and Efficacy of Tissue Engineered Endothelial Keratoplasty
Lead Sponsor:
Singapore Eye Research Institute
Conditions:
Mild to Moderate Corneal Endothelial Decompensation
Bullous Keratopathy
Eligibility:
All Genders
21-80 years
Phase:
PHASE1
Brief 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...
Detailed Description
The specific aim of this clinical trial is to assess the clinical efficacy and safety outcomes of patients receiving Tissue-Engineered Endothelial keratoplasty (TE-EK) graft material generated from hu...
Eligibility Criteria
Inclusion
- 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
- 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
Key Trial Info
Start Date :
December 1 2017
Trial Type :
INTERVENTIONAL
Allocation :
ESTIMATED
End Date :
June 1 2028
Estimated Enrollment :
30 Patients enrolled
Trial Details
Trial ID
NCT04319848
Start Date
December 1 2017
End Date
June 1 2028
Last Update
September 12 2025
Active Locations (1)
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1
Singapore Eye Research Institute
Singapore, Singapore