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
|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|
|Study Type :||Interventional (Clinical Trial)|
|Estimated Enrollment :||30 participants|
|Intervention Model:||Single Group Assignment|
|Intervention Model Description:||interventional|
|Masking:||None (Open Label)|
|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|
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.
- (BSCVA) [ Time Frame: 3 months ]BSCVA will be converted to logarithm of the minimum angle of resolution (logMAR) visual acuity for statistical analysis.
- Keratometric astigmatism and spherical equivalent [ Time Frame: 3 months ]Measured by an autokeratorefractometer (RK-8100; Topcon, Tokyo, Japan)
- Intraocular pressure measurement [ Time Frame: 3 Months ]Measured by a noncontact tonometry (CT-60; Topcon)
- 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.
- Graft thickness [ Time Frame: 1 month ]Measured by ASOCT (Visante OCT, Carl Zeiss Meditec)
- Contrast sensitivity [ Time Frame: 6 months ]Pentacam scatter
- Postoperative complications [ Time Frame: 1 month ]Postoperative complications, such as graft dislocation, graft rejection, will be evaluated with slit lamp biomicroscopy.
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
|Contact: Lee Yan Lim||+65 6576 email@example.com|
|Singapore Eye Research Institute||Recruiting|
|Contact: Lee Yan Lim|
|Principal Investigator:||Jodhbir Mehta||Singapore Eye Research Institute|