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Clinical Trials in Singapore / NCT04319848
Recruiting Phase 1

Safety and Efficacy of Tissue Engineered Endothelial Keratoplasty

NCT04319848 · tracked via the Priya Life Science Singapore tracker
Phase
Phase 1
Started
2017-12-01
Last updated
2025-09-12

Condition(s) studied

Mild to Moderate Corneal Endothelial DecompensationBullous KeratopathyFuchs' Endothelial DystrophyPost-surgical Corneal Decompensation (Irreversible)

Investigational drug(s) / intervention(s)

TE-EK treatment group

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)

Trial sites (1)

FacilityCityRegionStatus
Singapore Eye Research Institute Singapore Singapore Recruiting

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Other trials for the same condition

Official registry record

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.

View NCT04319848 on ClinicalTrials.gov ↗ ← All trials in Singapore