Bullous Keratopathy, Fuchs' Endothelial Dystrophy, Mild to Moderate Corneal Endothelial Decompensation, Post-surgical Corneal Decompensation (Irreversible)
Conditions
Brief 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.
Interventions
OTHERTE-EK treatment group
Transplantation of tissue-engineered endothelial graft through DSAEK procedure.
Sponsors
Singapore Eye Research Institute
Study design
Allocation
NA
Intervention model
SINGLE_GROUP
Primary purpose
TREATMENT
Masking
NONE
Intervention model description
interventional
Eligibility
Sex/Gender
ALL
Age
21 Years to 80 Years
Healthy volunteers
No
Inclusion criteria
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: * Fuchs' endothelial dystrophy * Post-surgical corneal decompensation (irreversible) - all forms of pseudophakic or aphakic bullous keratopathy
Exclusion criteria
* 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 * Patients not keen to participate in the clinical trial * Patients who are below 21 years of age or above 80 years of age * Patients who are pregnant * Patients who are cognitively impaired * Patients who are prisoners * Patients who are allergic to antibiotics
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| (BSCVA) | 3 months | BSCVA will be converted to logarithm of the minimum angle of resolution (logMAR) visual acuity for statistical analysis. |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Intraocular pressure measurement | 3 Months | Measured by a noncontact tonometry (CT-60; Topcon) |
| Endothelial cell density (ECD) | 3 months | 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. |
| Keratometric astigmatism and spherical equivalent | 3 months | Measured by an autokeratorefractometer (RK-8100; Topcon, Tokyo, Japan) |
| Contrast sensitivity | 6 months | Pentacam scatter |
| Postoperative complications | 1 month | Postoperative complications, such as graft dislocation, graft rejection, will be evaluated with slit lamp biomicroscopy. |
| Graft thickness | 1 month | Measured by ASOCT (Visante OCT, Carl Zeiss Meditec) |
Countries
Singapore
Contacts
Primary ContactLee Yan Lim
Outcome results
None listed