RecruitingPhase 1NCT04319848

Safety and Efficacy of Tissue Engineered Endothelial Keratoplasty

Safety and Efficacy of Tissue Engineered Endothelial Keratoplasty (TE-EK)

Sponsor

Singapore Eye Research Institute

Enrollment

30 participants

Start Date

Dec 1, 2017

Study Type

INTERVENTIONAL

Conditions

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

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

Min Age: 21 YearsMax Age: 80 Years

Inclusion Criteria3

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 Criteria10

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

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Interventions

OTHERTE-EK treatment group

Transplantation of tissue-engineered endothelial graft through DSAEK procedure.

Locations(1)

Singapore Eye Research Institute

Singapore, Singapore

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NCT04319848

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