NCT04319848

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).

Trial Health

77
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
30

participants targeted

Target at P25-P50 for phase_1

Timeline
25mo left

Started Dec 2017

Longer than P75 for phase_1

Geographic Reach
1 country

1 active site

Status
recruiting

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Progress80%
Dec 2017Jun 2028

First Submitted

Initial submission to the registry

November 19, 2017

Completed
12 days until next milestone

Study Start

First participant enrolled

December 1, 2017

Completed
2.3 years until next milestone

First Posted

Study publicly available on registry

March 24, 2020

Completed
7.7 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

December 1, 2027

Expected
6 months until next milestone

Study Completion

Last participant's last visit for all outcomes

June 1, 2028

Last Updated

September 12, 2025

Status Verified

September 1, 2025

Enrollment Period

10 years

First QC Date

November 19, 2017

Last Update Submit

September 5, 2025

Conditions

Mild to Moderate Corneal Endothelial DecompensationBullous KeratopathyFuchs' Endothelial DystrophyPost-surgical Corneal Decompensation (Irreversible)

Outcome Measures

Primary Outcomes (1)

  • (BSCVA)

    BSCVA will be converted to logarithm of the minimum angle of resolution (logMAR) visual acuity for statistical analysis.

    3 months

Secondary Outcomes (6)

  • Keratometric astigmatism and spherical equivalent

    3 months

  • Intraocular pressure measurement

    3 Months

  • Endothelial cell density (ECD)

    3 months

  • Graft thickness

    1 month

  • Contrast sensitivity

    6 months

  • +1 more secondary outcomes

Study Arms (1)

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.

Other: TE-EK treatment group

Interventions

TE-EK treatment groupOTHER

Transplantation of tissue-engineered endothelial graft through DSAEK procedure.

TE-EK treatment group

Eligibility Criteria

Age21 Years - 80 Years
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • 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

You may not qualify if:

  • 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

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Singapore Eye Research Institute

Singapore, Singapore

RECRUITING

Related Publications (1)

  • 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.

    PMID: 34633355DERIVED

MeSH Terms

Conditions

Fuchs' Endothelial Dystrophy

Condition Hierarchy (Ancestors)

Corneal Dystrophies, HereditaryCorneal DiseasesEye DiseasesEye Diseases, HereditaryGenetic Diseases, InbornCongenital, Hereditary, and Neonatal Diseases and Abnormalities

Study Officials

  • Jodhbir Mehta

    Singapore Eye Research Institute

    PRINCIPAL INVESTIGATOR

Central Study Contacts

Lee Yan Lim

CONTACT

+65 6576 7322lim.lee.yan@seri.com.sg

Study Design

Study Type
interventional
Phase
phase 1
Allocation
NA
Masking
NONE
Purpose
TREATMENT
Intervention Model
SINGLE GROUP
Model Details: interventional
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Senior Consultant Head Corneal and External Eye Disease and Refractive Service

Study Record Dates

First Submitted

November 19, 2017

First Posted

March 24, 2020

Study Start

December 1, 2017

Primary Completion (Estimated)

December 1, 2027

Study Completion (Estimated)

June 1, 2028

Last Updated

September 12, 2025

Record last verified: 2025-09

Locations

SG(1)