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Safety and Efficacy of Tissue Engineered Endothelial Keratoplasty

NCT04319848 · Status: RECRUITING · Phase: PHASE1 · Type: INTERVENTIONAL · Enrollment: 30

Last updated 2025-09-12

No results posted yet for this study

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).

Conditions

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

Interventions

OTHER

TE-EK treatment group

Transplantation of tissue-engineered endothelial graft through DSAEK procedure.

Sponsors & Collaborators

  • Singapore Eye Research Institute

    lead OTHER

Principal Investigators

  • Jodhbir Mehta · Singapore Eye Research Institute

Study Design

Allocation
NA
Purpose
TREATMENT
Masking
NONE
Model
SINGLE_GROUP

Eligibility

Min Age
21 Years
Max Age
80 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2017-12-01
Primary Completion
2027-12-31
Completion
2028-06-30

Countries

  • Singapore

Study Locations

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Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT04319848 on ClinicalTrials.gov