Safety and Efficacy of Tissue Engineered Endothelial Keratoplasty

Fuchs' Endothelial Dystrophy Clinical Trial

— TE-EK  

Official title:

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

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT04319848
• Other study ID #: R1391/77/2016
• Status: Recruiting
• Phase: Phase 1
• Start date: December 1, 2017
• Est. completion date: February 2021

Study information

• Verified date: March 2020
• Source: Singapore Eye Research Institute
• Contact: Lee Yan Lim
• Phone: +65 6576 7322
• Email: lim.lee.yan[@]seri.com.sg
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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).

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.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 30
• Est. completion date: February 2021
• Est. primary completion date: February 2021
• Accepts healthy volunteers: No
• Gender: All
• Age group: 21 Years to 80 Years

Eligibility

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

Related Conditions & MeSH terms

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

Intervention

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

Locations

Country	Name	City	State
Singapore	Singapore Eye Research Institute	Singapore

Sponsors (1)

Lead Sponsor	Collaborator
Singapore Eye Research Institute

Country where clinical trial is conducted

Singapore, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	(BSCVA)	BSCVA will be converted to logarithm of the minimum angle of resolution (logMAR) visual acuity for statistical analysis.	3 months
Secondary	Keratometric astigmatism and spherical equivalent	Measured by an autokeratorefractometer (RK-8100; Topcon, Tokyo, Japan)	3 months
Secondary	Intraocular pressure measurement	Measured by a noncontact tonometry (CT-60; Topcon)	3 Months
Secondary	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
Secondary	Graft thickness	Measured by ASOCT (Visante OCT, Carl Zeiss Meditec)	1 month
Secondary	Contrast sensitivity	Pentacam scatter	6 months
Secondary	Postoperative complications	Postoperative complications, such as graft dislocation, graft rejection, will be evaluated with slit lamp biomicroscopy.	1 month