Safety and Efficacy of Tissue Engineered Endothelial Keratoplasty

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

RECRUITING

Clinical Phase

PHASE1

Total Enrollment

30 participants

Study Classification

INTERVENTIONAL

Study Start Date

2017-12-01

Study Completion Date

2028-06-30

Brief Summary

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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).

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Detailed Description

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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.

Conditions

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

Study Design

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Allocation Method

NA

Intervention Model

SINGLE_GROUP

interventional

Primary Study Purpose

TREATMENT

Blinding Strategy

NONE

Study Groups

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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.

Group Type EXPERIMENTAL

TE-EK treatment group

Intervention Type OTHER

Transplantation of tissue-engineered endothelial graft through DSAEK procedure.

Interventions

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TE-EK treatment group

Transplantation of tissue-engineered endothelial graft through DSAEK procedure.

Intervention Type OTHER

Eligibility Criteria

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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

Minimum Eligible Age

21 Years

Maximum Eligible Age

80 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No