Mild to Moderate Corneal Endothelial DecompensationPhase 1TE-EKNCT04319848
Safety and Efficacy of Tissue Engineered Endothelial Keratoplasty
A Phase 1 study testing TE-EK treatment group in people with Mild to Moderate Corneal Endothelial Decompensation and Bullous Keratopathy, run by Singapore Eye Research Institute at 1 site in Singapore.
Trial 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). Read more about this study
- Who is it for?
- Ages 21 to 80 years
- Conditions the study is for
- Mild to Moderate Corneal Endothelial Decompensation, Bullous Keratopathy, Fuchs' Endothelial Dystrophy
- What is being tested?
- TE-EK treatment group
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 30 participants
- Where
- 1 siteSingapore
- Study dates
- 1 Dec 2017to Jun 2028
- Phase
- Phase 1
- Are there results?
- Not yet: the study is under way
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 21 to 80 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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
Who cannot join
- 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
Show all 10Show fewer
- Patients who are pregnant
- Patients who are cognitively impaired
- Patients who are prisoners
- Patients who are allergic to antibiotics
Trial locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
Singapore1 site, 1 recruiting
- Recruiting
Singapore Eye Research Institute
Singapore
Lee Yan Lim
About this study
Official 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).
Read the 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.
- Conditions
- Mild to Moderate Corneal Endothelial Decompensation, Bullous Keratopathy, Fuchs' Endothelial Dystrophy, Post-surgical Corneal Decompensation (Irreversible)
- Being tested
- TE-EK treatment group
- Medical subject headings
- Fuchs' Endothelial Dystrophy
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
TE-EK treatment groupOther
Transplantation of tissue-engineered endothelial graft through DSAEK procedure.
| Study group | Role | What they receive |
|---|---|---|
| TE-EK treatment group | Experimental | 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. Receives: Other: TE-EK treatment group |
What is being measured
The primary outcome is the main question the study is designed to answer.
(BSCVA)
BSCVA will be converted to logarithm of the minimum angle of resolution (logMAR) visual acuity for statistical analysis.
Measured: 3 months
Secondary outcomes (6)
Keratometric astigmatism and spherical equivalent
Measured by an autokeratorefractometer (RK-8100; Topcon, Tokyo, Japan)
Measured: 3 months
Intraocular pressure measurement
Measured by a noncontact tonometry (CT-60; Topcon)
Measured: 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.
Measured: 3 months
Graft thickness
Measured by ASOCT (Visante OCT, Carl Zeiss Meditec)
Measured: 1 month
Contrast sensitivity
Pentacam scatter
Measured: 6 months
Postoperative complications
Postoperative complications, such as graft dislocation, graft rejection, will be evaluated with slit lamp biomicroscopy.
Measured: 1 month
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted24 Mar 2020
- Study start1 Dec 2017
- Primary completionDec 2027 (estimated)
- Study completionJun 2028 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for Mild to Moderate Corneal Endothelial DecompensationStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 1
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Model description
- interventional
- Masking
- None (open label)
- Enrolment
- 30 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Singapore Eye Research Institute
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Jodhbir Mehta, Singapore Eye Research Institute
- Investigators
- Jodhbir Mehta, Principal investigator, Singapore Eye Research Institute
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04319848
- Sponsor's protocol ID
- R1391/77/2016
- Acronym
- TE-EK
- Status last verified
- Sep 2025
- First submitted
- 19 Nov 2017
- Last updated
- 12 Sep 2025
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Undecided
Publications
Soh YQ, Poh SSJ, Peh GSL, Mehta JS. New Therapies for Corneal Endothelial Diseases: 2020 and Beyond. Cornea. 2021 Nov 1;40(11):1365-1373. doi: 10.1097/ICO.0000000000002687.
PubMed 34633355
Study at a glance
From the registry record, last updated by the sponsor on 12 Sep 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Safety and Efficacy of Tissue Engineered Endothelial Keratoplasty (TE-EK)
- ClinicalTrials.gov ID
- NCT04319848
- Acronym / sponsor ID
- TE-EK / R1391/77/2016
- Conditions
- Mild to Moderate Corneal Endothelial Decompensation, Bullous Keratopathy, Fuchs' Endothelial Dystrophy, Post-surgical Corneal Decompensation (Irreversible)
- Phase
- Phase 1
- Study type
- Interventional
- Recruitment status
- Recruiting
- Enrolment
- 30 participants (estimated)
- Lead sponsor
- Singapore Eye Research InstituteUniversity, hospital or other
- Study start
- 1 Dec 2017 (actual)
- Primary completion
- Dec 2027 (estimated)
- Study completion
- Jun 2028 (estimated)
- First posted
- 24 Mar 2020 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
- Model description
- interventional
| Arm | Type | Receives |
|---|---|---|
| TE-EK treatment group | Experimental | Other: TE-EK treatment groupThe 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. |
Who may qualify
- Ages
- 21 to 80 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (3 listed)
- 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
Key exclusion criteria (10 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| TE-EK treatment groupTransplantation of tissue-engineered endothelial graft through DSAEK procedure. | Other | TE-EK treatment group |
Primary outcome
(BSCVA)
Time frame: 3 months
BSCVA will be converted to logarithm of the minimum angle of resolution (logMAR) visual acuity for statistical analysis.
6 secondary outcomes
Keratometric astigmatism and spherical equivalent
Time frame: 3 months
Intraocular pressure measurement
Time frame: 3 Months
Endothelial cell density (ECD)
Time frame: 3 months
Graft thickness
Time frame: 1 month
Contrast sensitivity
Time frame: 6 months
Postoperative complications
Time frame: 1 month
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 12 Sep 2025.
- Derived from this study: PubMed 34633355Soh YQ, Poh SSJ, Peh GSL, Mehta JS. New Therapies for Corneal Endothelial Diseases: 2020 and Beyond. Cornea. 2021 Nov 1;40(11):1365-1373. doi: 10.1097/ICO.0000000000002687.
- Individual participant dataSharing planned: Undecided
Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part.
Jodhbir Mehta principal investigator
Singapore Eye Research Institute
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 1 study testing TE-EK treatment group in people with Mild to Moderate Corneal Endothelial Decompensation and Bullous Keratopathy, run by Singapore Eye Research Institute at 1 site in Singapore.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 3 inclusion and 10 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: looking for participants now, as of the sponsor's last update on 12 Sep 2025. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Singapore. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this phase mean?
Phase 1 studies test a treatment in a small group of people for the first time or in a new way, mainly to check safety and find the right dose.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact Lee Yan Lim (+65 6576 7322, lim.lee.yan@seri.com.sg), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
(BSCVA) (time frame: 3 months). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT04319848, which also lists 1 linked publication.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 12 Sep 2025.