A Phase 1 interventional study of TE-EK treatment group in Mild to Moderate Corneal Endothelial Decompensation, Bullous Keratopathy and Fuchs' Endothelial Dystrophy, sponsored by Singapore Eye Research Institute. Recruiting at 1 site in Singapore. Open to participants aged 21 Years to 80 Years. Per ClinicalTrials.gov, last updated 2025-09-12.
Sponsored by Singapore Eye Research Institute · Phase 1, Interventional, and Treatment
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).
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.
92 studies on the registry are indexed under Fuchs' Endothelial Dystrophy; 27 are open to participants now.
This study's planned enrollment of 30 is below the median of 50 across 62 interventional studies indexed under Fuchs' Endothelial Dystrophy.
Browse Fuchs' Endothelial Dystrophy studies →Singapore Eye Research Institute is the lead sponsor of 27 studies on the registry; 12 are open to participants now.
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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:
Exclusion Criteria:
The TE-EK surgery will be performed by the Principle Investigator with a standard DSAEK technique. The PI has performed over 300, EK surgeries and we have previously shown that the corneal endothelial loss rates from the PI are 16% at 1 year with a primary graft failure rates of \<1.5%. A patient's participation in the study or not will not change the treatment strategy in any manner.
Other: TE-EK treatment group
Transplantation of tissue-engineered endothelial graft through DSAEK procedure.
(BSCVA)
BSCVA will be converted to logarithm of the minimum angle of resolution (logMAR) visual acuity for statistical analysis.
Time frame: 3 months
Keratometric astigmatism and spherical equivalent
Measured by an autokeratorefractometer (RK-8100; Topcon, Tokyo, Japan)
Time frame: 3 months
Intraocular pressure measurement
Measured by a noncontact tonometry (CT-60; Topcon)
Time frame: 3 Months
Endothelial cell density (ECD)
Measured by a noncontact specular microscope (Konan Medical Corp, Hyogo, Japan). The ECD data will be expressed as percentage of cell loss compared with the donor ECD.
Time frame: 3 months
Graft thickness
Measured by ASOCT (Visante OCT, Carl Zeiss Meditec)
Time frame: 1 month
Contrast sensitivity
Pentacam scatter
Time frame: 6 months
Postoperative complications
Postoperative complications, such as graft dislocation, graft rejection, will be evaluated with slit lamp biomicroscopy.
Time frame: 1 month
Plan to share: Undecided
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Fuchs' Endothelial Dystrophy →
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