Safety and Efficacy of Tissue Engineered Endothelial Keratoplasty (NCT04319848) | Clinical Trial Compass
RecruitingPhase 1
Safety and Efficacy of Tissue Engineered Endothelial Keratoplasty
Singapore30 participantsStarted 2017-12-01
Plain-language 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).
Who can participate
Age range21 Years – 80 Years
SexALL
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AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.
Inclusion Criteria:
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
Exclusion Criteria:
* 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
* Patients not keen to participate in the clinical trial
* Patients who are below 21 years of age or above 80 years of age
* Patients who are pregnant
* Patients who are cognitively impaired
* Patients who are prisoners
* Patients who are allergic to antibiotics