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).
Fuchs' endothelial dystrophy
Post-surgical corneal decompensation (irreversible) - all forms of pseudophakic or aphakic bullous keratopathy
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
Single group
TE-EK treatment group
Other interventionTransplantation 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.
Keratometric astigmatism and spherical equivalent
Measured by an autokeratorefractometer (RK-8100; Topcon, Tokyo, Japan)
Intraocular pressure measurement
Measured by a noncontact tonometry (CT-60; Topcon)
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.
Graft thickness
Measured by ASOCT (Visante OCT, Carl Zeiss Meditec)
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