Safety and Efficacy of Tissue Engineered Endothelial Keratoplasty (TE-EK)
September 5, 2025 updated by: Jodhbir Mehta, Singapore Eye Research Institute
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).
Study Overview
Status
Recruiting
Conditions
Intervention / Treatment
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.
Study Type
Interventional
Enrollment (Estimated)
30
Phase
- Phase 1
Contacts and Locations
This section provides the contact details for those conducting the study, and information on where this study is being conducted.
Study Contact
- Name: Lee Yan Lim
- Phone Number: +65 6576 7322
- Email: lim.lee.yan@seri.com.sg
Study Locations
-
-
-
Singapore, Singapore
- Recruiting
- Singapore Eye Research Institute
-
Contact:
- Lee Yan Lim
-
-
Participation Criteria
Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.
Eligibility Criteria
Ages Eligible for Study
21 years to 80 years (Adult, Older Adult)
Accepts Healthy Volunteers
No
Description
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
Study Plan
This section provides details of the study plan, including how the study is designed and what the study is measuring.
How is the study designed?
Design Details
- Primary Purpose: Treatment
- Allocation: N/A
- Interventional Model: Single Group Assignment
- Masking: None (Open Label)
Arms and Interventions
Participant Group / Arm |
Intervention / Treatment |
|---|---|
|
Experimental: TE-EK treatment group
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.
|
Transplantation of tissue-engineered endothelial graft through DSAEK procedure.
|
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
|---|---|---|
|
(BSCVA)
Time Frame: 3 months
|
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
Time Frame: 3 months
|
Measured by an autokeratorefractometer (RK-8100; Topcon, Tokyo, Japan)
|
3 months
|
|
Intraocular pressure measurement
Time Frame: 3 Months
|
Measured by a noncontact tonometry (CT-60; Topcon)
|
3 Months
|
|
Endothelial cell density (ECD)
Time Frame: 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.
|
3 months
|
|
Graft thickness
Time Frame: 1 month
|
Measured by ASOCT (Visante OCT, Carl Zeiss Meditec)
|
1 month
|
|
Contrast sensitivity
Time Frame: 6 months
|
Pentacam scatter
|
6 months
|
|
Postoperative complications
Time Frame: 1 month
|
Postoperative complications, such as graft dislocation, graft rejection, will be evaluated with slit lamp biomicroscopy.
|
1 month
|
Collaborators and Investigators
This is where you will find people and organizations involved with this study.
Sponsor
Investigators
- Principal Investigator: Jodhbir Mehta, Singapore Eye Research Institute
Publications and helpful links
The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.
Study record dates
These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.
Study Major Dates
Study Start (Actual)
December 1, 2017
Primary Completion (Estimated)
December 1, 2027
Study Completion (Estimated)
June 1, 2028
Study Registration Dates
First Submitted
November 19, 2017
First Submitted That Met QC Criteria
March 22, 2020
First Posted (Actual)
March 24, 2020
Study Record Updates
Last Update Posted (Estimated)
September 12, 2025
Last Update Submitted That Met QC Criteria
September 5, 2025
Last Verified
September 1, 2025
More Information
Terms related to this study
Additional Relevant MeSH Terms
Other Study ID Numbers
- R1391/77/2016
Plan for Individual participant data (IPD)
Plan to Share Individual Participant Data (IPD)?
UNDECIDED
Drug and device information, study documents
Studies a U.S. FDA-regulated drug product
No
Studies a U.S. FDA-regulated device product
No
product manufactured in and exported from the U.S.
No
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.