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Safety and Efficacy of Tissue Engineered Endothelial Keratoplasty — TE-EK  

Fuchs' Endothelial Dystrophy Clinical Trial

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

Clinical Trial 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).

Clinical Trial 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. ;

Study Design

Related Conditions & MeSH terms

Clinical Trial Details
NCT number NCT04319848
Study type Interventional
Source Singapore Eye Research Institute
Contact Lee Yan Lim
Phone +65 6576 7322
Email lim.lee.yan@seri.com.sg
Status Recruiting
Phase Phase 1
Start date December 1, 2017
Completion date February 2021
View Details
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