Safety and Efficacy of Tissue Engineered Endothelial Keratoplasty

Trial statusRecruiting
Trial phasePhase 1
Trial typeInterventional
Biological sexAll
Age21-80
SponsorSingapore Eye Research Institute

About this trial

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 criteria

Qualifiers

Fuchs' endothelial dystrophy

Post-surgical corneal decompensation (irreversible) - all forms of pseudophakic or aphakic bullous keratopathy

Disqualifiers

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

Trial design

Treatments tested in this trial

  • TE-EK treatment group

Treatment groups

30 Participants
are divided into 1 treatment group