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

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Know the risks and potential benefits of clinical studies and talk to your health care provider before participating. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT04319848
Recruitment Status : Recruiting
First Posted : March 24, 2020
Last Update Posted : March 24, 2020
Sponsor:
Information provided by (Responsible Party):
Jodhbir Mehta, 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).

Condition or disease Intervention/treatment Phase
Mild to Moderate Corneal Endothelial Decompensation Bullous Keratopathy Fuchs' Endothelial Dystrophy Post-surgical Corneal Decompensation (Irreversible) Other: TE-EK treatment group Phase 1

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.

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Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 30 participants
Allocation: N/A
Intervention Model: Single Group Assignment
Intervention Model Description: interventional
Masking: None (Open Label)
Primary Purpose: Treatment
Official Title: Safety and Efficacy of Tissue Engineered Endothelial Keratoplasty (TE-EK)
Actual Study Start Date : December 1, 2017
Estimated Primary Completion Date : February 2021
Estimated Study Completion Date : February 2021

Resource links provided by the National Library of Medicine


Arm Intervention/treatment
Experimental: 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.
Other: TE-EK treatment group
Transplantation of tissue-engineered endothelial graft through DSAEK procedure.




Primary Outcome Measures :
  1. (BSCVA) [ Time Frame: 3 months ]
    BSCVA will be converted to logarithm of the minimum angle of resolution (logMAR) visual acuity for statistical analysis.


Secondary Outcome Measures :
  1. Keratometric astigmatism and spherical equivalent [ Time Frame: 3 months ]
    Measured by an autokeratorefractometer (RK-8100; Topcon, Tokyo, Japan)

  2. Intraocular pressure measurement [ Time Frame: 3 Months ]
    Measured by a noncontact tonometry (CT-60; Topcon)

  3. Endothelial cell density (ECD) [ Time Frame: 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.

  4. Graft thickness [ Time Frame: 1 month ]
    Measured by ASOCT (Visante OCT, Carl Zeiss Meditec)

  5. Contrast sensitivity [ Time Frame: 6 months ]
    Pentacam scatter

  6. Postoperative complications [ Time Frame: 1 month ]
    Postoperative complications, such as graft dislocation, graft rejection, will be evaluated with slit lamp biomicroscopy.



Information from the National Library of Medicine

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Ages Eligible for Study:   21 Years to 80 Years   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT04319848


Contacts
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Contact: Lee Yan Lim +65 6576 7322 lim.lee.yan@seri.com.sg

Locations
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Singapore
Singapore Eye Research Institute Recruiting
Singapore, Singapore
Contact: Lee Yan Lim         
Sponsors and Collaborators
Singapore Eye Research Institute
Investigators
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Principal Investigator: Jodhbir Mehta Singapore Eye Research Institute
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Responsible Party: Jodhbir Mehta, Senior Consultant Head Corneal and External Eye Disease and Refractive Service, Singapore Eye Research Institute
ClinicalTrials.gov Identifier: NCT04319848    
Other Study ID Numbers: R1391/77/2016
First Posted: March 24, 2020    Key Record Dates
Last Update Posted: March 24, 2020
Last Verified: March 2020
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: Undecided

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Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
Additional relevant MeSH terms:
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Fuchs' Endothelial Dystrophy
Corneal Dystrophies, Hereditary
Corneal Diseases
Eye Diseases
Eye Diseases, Hereditary
Genetic Diseases, Inborn