Safety and Efficacy of Tissue Engineered Endothelial Keratoplasty

Study Overview
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Brief Summary
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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
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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.

Official Title
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Safety and Efficacy of Tissue Engineered Endothelial Keratoplasty (TE-EK)

Conditions
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Mild to Moderate Corneal Endothelial Decompensation, Bullous Keratopathy, Fuchs' Endothelial Dystrophy, Post-surgical Corneal Decompensation (Irreversible)

Intervention / Treatment
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* Other: TE-EK treatment group


Participation Criteria
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Eligibility Criteria
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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

Ages Eligible for Study
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Minimum Age: 21 Years
Maximum Age: 80 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Intervention Model: Single Group Assignment
Interventional Model Description: interventional
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: TE-EK treatment group<br>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<br>* Transplantation of tissue-engineered endothelial graft through DSAEK procedure.<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| (BSCVA) | BSCVA will be converted to logarithm of the minimum angle of resolution (logMAR) visual acuity for statistical analysis. | 3 months | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Keratometric astigmatism and spherical equivalent | Measured by an autokeratorefractometer (RK-8100; Topcon, Tokyo, Japan) | 3 months | 
| Intraocular pressure measurement | Measured by a noncontact tonometry (CT-60; Topcon) | 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. | 3 months | 
| Graft thickness | Measured by ASOCT (Visante OCT, Carl Zeiss Meditec) | 1 month | 
| Contrast sensitivity | Pentacam scatter | 6 months | 
| Postoperative complications | Postoperative complications, such as graft dislocation, graft rejection, will be evaluated with slit lamp biomicroscopy. | 1 month |