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Recruiting NCT04319848

Safety and Efficacy of Tissue Engineered Endothelial Keratoplasty

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

For patients and families

In plain language

An automatic summary of structured registry data. It is an orientation aid, not a substitute for the official protocol or a physician assessment.

What is being studied
The protocol lists: TE-EK treatment group.
Who it may be relevant to
Registry conditions: Mild to Moderate Corneal Endothelial Decompensation, Bullous Keratopathy, Fuchs' Endothelial Dystrophy, Post-surgical Corneal Decompensation (Irreversible). Basic parameters: 21 years — 80 years · All.
What needs checking
Age, condition and sex are only basic indicators. Prior treatment, laboratory values and other mandatory requirements appear in the eligibility criteria below.
Where it takes place
Singapore
Next step
Save the trial, show it to the treating physician, and confirm current recruitment with the study center. Costs, documents and travel →

Unsure about the terms? Read our patient guide →

Official title

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

Overview

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.

Interventions

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

Primary outcome measures

  • (BSCVA) [Time frame: 3 months]
Secondary outcome measures (6)
  • Keratometric astigmatism and spherical equivalent [Time frame: 3 months]
  • Intraocular pressure measurement [Time frame: 3 Months]
  • Endothelial cell density (ECD) [Time frame: 3 months]
  • Graft thickness [Time frame: 1 month]
  • Contrast sensitivity [Time frame: 6 months]
  • Postoperative complications [Time frame: 1 month]

Eligibility criteria

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

Criteria are shown verbatim from the registry (in English). Final eligibility is always assessed by the study center.

Healthy volunteers: No

Study design

Allocation
N/A
Model
Single group
Masking
Open label
Primary purpose
Treatment

Study locations

Singapore · 1 center
  • Singapore Eye Research Institute — Singapore

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. PMID 34633355

Identifiers

NCT: NCT04319848 · R1391/77/2016

Primary sources (government registries)

View this study on ClinicalTrials.gov ↗