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

Singapore Eye Research Institute

Status and phase: Enrolling; Phase 1

Conditions: Bullous Keratopathy; Fuchs' Endothelial Dystrophy; Mild to Moderate Corneal Endothelial Decompensation; Post-surgical Corneal Decompensation (Irreversible)

Treatments: Other: TE-EK treatment group

Study type: Interventional

Funder types: Other

Identifiers

NCT04319848

R1391/77/2016

Details and patient eligibility

About

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).

Full 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.

Enrollment: 30 estimated patients

Sex: All

Ages: 21 to 80 years old

Volunteers: No 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

Trial design

Primary purpose: Treatment

Allocation: N/A

Interventional model: Single Group Assignment

Masking: None (Open label)

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30 participants in 1 patient group

TE-EK treatment group

Experimental group

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.

Treatment:

Other: TE-EK treatment group