Actively Recruiting

Phase 1
Age: 21Years - 80Years
All Genders
NCT04319848

Safety and Efficacy of Tissue Engineered Endothelial Keratoplasty

Led by Singapore Eye Research Institute · Updated on 2025-09-12

30

Participants Needed

1

Research Sites

547 weeks

Total Duration

On this page

AI-Summary

What this Trial Is About

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

Official Title

Safety and Efficacy of Tissue Engineered Endothelial Keratoplasty

Who Can Participate

Age: 21Years - 80Years
All Genders

Eligibility Criteria

Eligible

You may qualify if you...

  • Patients with mild to moderate corneal endothelial decompensation or bullous keratopathy with minimal corneal stromal scarring
  • Conditions include Fuchs' endothelial dystrophy and irreversible post-surgical corneal decompensation (all forms of pseudophakic or aphakic bullous keratopathy)
  • Age between 21 and 80 years
Not Eligible

You will not qualify if you...

  • Severe or late-stage corneal decompensation with severe corneal stromal scarring unsuitable for TE-EK surgery
  • Complex anterior segment complications preventing successful TE-EK procedure
  • Other endothelial dystrophies, traumatic corneal decompensation, or post-inflammatory corneal decompensation
  • Corneal decompensation related to post-laser iridotomy or glaucoma
  • Unwillingness to participate in the clinical trial
  • Age below 21 years or above 80 years
  • Pregnancy
  • Cognitive impairment
  • Prisoner status
  • Allergy to antibiotics

AI-Screening

AI-Powered Screening

Complete this quick 3-step screening to check your eligibility

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Trial Site Locations

Total: 1 location

1

Singapore Eye Research Institute

Singapore, Singapore

Actively Recruiting

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Research Team

L

Lee Yan Lim

CONTACT

How is the study designed?

Study Type

INTERVENTIONAL

Masking

NONE

Allocation

NA

Model

SINGLE_GROUP

Primary Purpose

TREATMENT

Number of Arms

1

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