Fuchs' Endothelial Dystrophy Clinical Trial
— TE-EKOfficial title:
Safety and Efficacy of Tissue Engineered Endothelial Keratoplasty (TE-EK)
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).
Status | Recruiting |
Enrollment | 30 |
Est. completion date | February 2021 |
Est. primary completion date | February 2021 |
Accepts healthy volunteers | No |
Gender | All |
Age group | 21 Years to 80 Years |
Eligibility |
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 |
Country | Name | City | State |
---|---|---|---|
Singapore | Singapore Eye Research Institute | Singapore |
Lead Sponsor | Collaborator |
---|---|
Singapore Eye Research Institute |
Singapore,
Type | Measure | Description | Time frame | Safety issue |
---|---|---|---|---|
Primary | (BSCVA) | BSCVA will be converted to logarithm of the minimum angle of resolution (logMAR) visual acuity for statistical analysis. | 3 months | |
Secondary | Keratometric astigmatism and spherical equivalent | Measured by an autokeratorefractometer (RK-8100; Topcon, Tokyo, Japan) | 3 months | |
Secondary | Intraocular pressure measurement | Measured by a noncontact tonometry (CT-60; Topcon) | 3 Months | |
Secondary | 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. | 3 months | |
Secondary | Graft thickness | Measured by ASOCT (Visante OCT, Carl Zeiss Meditec) | 1 month | |
Secondary | Contrast sensitivity | Pentacam scatter | 6 months | |
Secondary | Postoperative complications | Postoperative complications, such as graft dislocation, graft rejection, will be evaluated with slit lamp biomicroscopy. | 1 month |
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