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

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: Unknown
• Conditions: Fuchs' Endothelial Dystrophy; Bullous Keratopathy; Mild to Moderate Corneal Endothelial Decompensation; Post-surgical Corneal Decompensation (Irreversible)
• Intervention / Treatment: Other: TE-EK treatment group

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 (Anticipated): 30
• Phase: Phase 1

Contacts and Locations

• Study Contact: Name: Lee Yan Lim; Phone Number: +65 6576 7322; Email: lim.lee.yan@seri.com.sg

Study Locations

• Singapore
  • Singapore, Singapore
    • Recruiting
    • Singapore Eye Research Institute
    • Contact: Lee Yan Lim

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 21 years to 80 years (ADULT, OLDER_ADULT)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

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

How is the study designed?

Design Details

• Primary Purpose: TREATMENT
• Allocation: NA
• Interventional Model: SINGLE_GROUP
• Masking: NONE

Number of Arms

1

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.

Other: TE-EK treatment group; Transplantation of tissue-engineered endothelial graft through DSAEK procedure.

What is the study measuring?

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

Collaborators and Investigators

• Sponsor: Singapore Eye Research Institute
• Investigators: Principal Investigator: Jodhbir Mehta, Singapore Eye Research Institute

Publications and helpful links

General 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.

Study record dates

Study Major Dates

• Study Start (ACTUAL): December 1, 2017
• Primary Completion (ANTICIPATED): February 1, 2021
• Study Completion (ANTICIPATED): February 1, 2021

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 (ACTUAL): March 24, 2020
• Last Update Submitted That Met QC Criteria: March 22, 2020
• Last Verified: March 1, 2020

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Eye Diseases; Genetic Diseases, Inborn; Eye Diseases, Hereditary; Corneal Diseases; Corneal Dystrophies, Hereditary; Fuchs' Endothelial Dystrophy
• 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