Safety and Efficacy of Tissue Engineered Endothelial Keratoplasty (TE-EK)
Who is this study for? Patients with Mild to Moderate Corneal Endothelial Decompensation, Bullous Keratopathy
What treatments are being studied? TE-EK Treatment Group
Status: Recruiting
Location: See location...
Intervention Type: Other
Study Type: Interventional
Study Phase: Phase 1
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).
Eligibility
Participation Requirements
Sex: All
Minimum Age: 21
Maximum Age: 80
Healthy Volunteers: f
View:
⁃ 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
Locations
Other Locations
Singapore
Singapore Eye Research Institute
RECRUITING
Singapore
Contact Information
Primary
Lee Yan Lim
lim.lee.yan@seri.com.sg
+65 6576 7322
Time Frame
Start Date: 2017-12-01
Estimated Completion Date: 2028-06
Participants
Target number of participants: 30
Treatments
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.
Related Therapeutic Areas
Sponsors
Leads: Singapore Eye Research Institute