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.
Study Type
INTERVENTIONAL
Allocation
NA
Purpose
TREATMENT
Masking
NONE
Enrollment
30
Transplantation of tissue-engineered endothelial graft through DSAEK procedure.
Singapore Eye Research Institute
Singapore, Singapore
RECRUITING(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
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