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

Primary Purpose

Mild to Moderate Corneal Endothelial Decompensation, Bullous Keratopathy, Fuchs' Endothelial Dystrophy

Status
Unknown status
Phase
Phase 1
Locations
Singapore
Study Type
Interventional
Intervention
TE-EK treatment group
Sponsored by
Singapore Eye Research Institute
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Mild to Moderate Corneal Endothelial Decompensation

Eligibility Criteria

21 Years - 80 Years (Adult, Older Adult)All SexesDoes not accept healthy volunteers

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

Sites / Locations

  • Singapore Eye Research InstituteRecruiting

Arms of the Study

Arm 1

Arm Type

Experimental

Arm Label

TE-EK treatment group

Arm Description

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.

Outcomes

Primary Outcome Measures

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

Secondary Outcome Measures

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

Full Information

First Posted
November 19, 2017
Last Updated
March 22, 2020
Sponsor
Singapore Eye Research Institute
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1. Study Identification

Unique Protocol Identification Number
NCT04319848
Brief Title
Safety and Efficacy of Tissue Engineered Endothelial Keratoplasty
Acronym
TE-EK
Official Title
Safety and Efficacy of Tissue Engineered Endothelial Keratoplasty (TE-EK)
Study Type
Interventional

2. Study Status

Record Verification Date
March 2020
Overall Recruitment Status
Unknown status
Study Start Date
December 1, 2017 (Actual)
Primary Completion Date
February 2021 (Anticipated)
Study Completion Date
February 2021 (Anticipated)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
Singapore Eye Research Institute

4. Oversight

Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
Yes

5. Study Description

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).
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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Mild to Moderate Corneal Endothelial Decompensation, Bullous Keratopathy, Fuchs' Endothelial Dystrophy, Post-surgical Corneal Decompensation (Irreversible)

7. Study Design

Primary Purpose
Treatment
Study Phase
Phase 1
Interventional Study Model
Single Group Assignment
Model Description
interventional
Masking
None (Open Label)
Allocation
N/A
Enrollment
30 (Anticipated)

8. Arms, Groups, and Interventions

Arm Title
TE-EK treatment group
Arm Type
Experimental
Arm Description
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.
Intervention Type
Other
Intervention Name(s)
TE-EK treatment group
Intervention Description
Transplantation of tissue-engineered endothelial graft through DSAEK procedure.
Primary Outcome Measure Information:
Title
(BSCVA)
Description
BSCVA will be converted to logarithm of the minimum angle of resolution (logMAR) visual acuity for statistical analysis.
Time Frame
3 months
Secondary Outcome Measure Information:
Title
Keratometric astigmatism and spherical equivalent
Description
Measured by an autokeratorefractometer (RK-8100; Topcon, Tokyo, Japan)
Time Frame
3 months
Title
Intraocular pressure measurement
Description
Measured by a noncontact tonometry (CT-60; Topcon)
Time Frame
3 Months
Title
Endothelial cell density (ECD)
Description
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.
Time Frame
3 months
Title
Graft thickness
Description
Measured by ASOCT (Visante OCT, Carl Zeiss Meditec)
Time Frame
1 month
Title
Contrast sensitivity
Description
Pentacam scatter
Time Frame
6 months
Title
Postoperative complications
Description
Postoperative complications, such as graft dislocation, graft rejection, will be evaluated with slit lamp biomicroscopy.
Time Frame
1 month

10. Eligibility

Sex
All
Minimum Age & Unit of Time
21 Years
Maximum Age & Unit of Time
80 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
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
Central Contact Person:
First Name & Middle Initial & Last Name or Official Title & Degree
Lee Yan Lim
Phone
+65 6576 7322
Email
lim.lee.yan@seri.com.sg
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Jodhbir Mehta
Organizational Affiliation
Singapore Eye Research Institute
Official's Role
Principal Investigator
Facility Information:
Facility Name
Singapore Eye Research Institute
City
Singapore
Country
Singapore
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Lee Yan Lim

12. IPD Sharing Statement

Plan to Share IPD
Undecided
Citations:
PubMed Identifier
34633355
Citation
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.
Results Reference
derived

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Safety and Efficacy of Tissue Engineered Endothelial Keratoplasty

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