Safety and Efficacy of Tissue Engineered Endothelial Keratoplasty

Phase 1

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

• Registration Number: NCT04319848
• Lead Sponsor: Singapore Eye Research Institute

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.

Study Timeline

• Study First Submitted: 2017-11-19
• Study Start: 2017-12-01
• Status Verified: 2020-03
• Study First Submitted QC: 2020-03-22
• Last Update Submitted: 2020-03-22
• Study First Posted: 2020-03-24
• Last Update Posted: 2020-03-24
• Primary Completion: 2021-02
• Study Completion: 2021-02

Recruitment & Eligibility

• Status: UNKNOWN
• Sex: All
• Target Recruitment: 30

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 & Design

• Study Type: INTERVENTIONAL
• Study Design: SINGLE_GROUP

Arm && Interventions

Group	Intervention	Description
TE-EK treatment group	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.

Primary Outcome Measures

Name	Time	Method
(BSCVA)	3 months	BSCVA will be converted to logarithm of the minimum angle of resolution (logMAR) visual acuity for statistical analysis.

Secondary Outcome Measures

Name	Time	Method
Keratometric astigmatism and spherical equivalent	3 months	Measured by an autokeratorefractometer (RK-8100; Topcon, Tokyo, Japan)
Intraocular pressure measurement	3 Months	Measured by a noncontact tonometry (CT-60; Topcon)
Endothelial cell density (ECD)	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.
Graft thickness	1 month	Measured by ASOCT (Visante OCT, Carl Zeiss Meditec)
Contrast sensitivity	6 months	Pentacam scatter
Postoperative complications	1 month	Postoperative complications, such as graft dislocation, graft rejection, will be evaluated with slit lamp biomicroscopy.

Trial Locations

Locations (1)

Singapore Eye Research Institute; 🇸🇬 Singapore, Singapore