NCT04319848

Safety and Efficacy of Tissue Engineered Endothelial Keratoplasty

Safety and Efficacy of Tissue Engineered Endothelial Keratoplasty (TE-EK)

• Status: Recruiting
• Phase: Phase 1
• Study type: Interventional
• Enrollment: 30 (estimated)
• Sponsor: Singapore Eye Research Institute · Academic / Other
• Sex: All
• Age: 21 Years – 80 Years
• Healthy volunteers: Not accepted

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 human corneal endothelial cells (HCEnCs) propagated in a regulatory-approved dual media approach. Post-operative follow-ups and visits will follow current EK protocols of Singapore National Eye Centre. Clinical assessments include postoperative visual acuity, intraocular pressure, keratometric astigmatism, spherical equivalent, endothelial cell density, anterior segment optical coherence tomography (ASOCT), contrast sensitivity, as well as any postoperative complications such as graft dislocation or primary graft failure.

Conditions

• Mild to Moderate Corneal Endothelial Decompensation
• Bullous Keratopathy
• Fuchs' Endothelial Dystrophy
• Post-surgical Corneal Decompensation (Irreversible)

Interventions

Type	Name	Description
OTHER	TE-EK treatment group	Transplantation of tissue-engineered endothelial graft through DSAEK procedure.

Timeline

• Start date: 2017-12-01
• Primary completion: 2027-12-01
• Completion: 2028-06-01
• First posted: 2020-03-24
• Last updated: 2025-09-12

Locations

1 site across 1 country: Singapore