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

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

Plain Language Summary

Simplified for easier understanding

This study is testing a new type of corneal transplant surgery called Tissue-Engineered Endothelial Keratoplasty (TE-EK). The inner layer of the cornea (the clear window at the front of the eye) contains special cells called endothelial cells that keep the cornea clear. When these cells stop working properly, the cornea becomes cloudy and vision deteriorates — a condition called corneal decompensation. Instead of using a donor cornea from another person, this experimental approach uses laboratory-grown cells to replace the damaged inner layer. The study will assess whether this technique is safe and effective in restoring vision. You may be eligible if: - You have mild to moderate corneal clouding due to Fuchs' endothelial dystrophy - You have corneal decompensation following eye surgery (such as cataract surgery) - You are between 21 and 80 years of age You may NOT be eligible if: - You have severe corneal scarring requiring a full-thickness corneal transplant - You have complex eye anatomy making this type of surgery unsafe - You have other types of corneal disease (e.g., trauma-related, post-inflammatory) - You are pregnant, cognitively impaired, or incarcerated - You are allergic to antibiotics Talk to your doctor to see if this trial is right for you.

This summary was AI-generated to explain the trial in plain language. It is not medical advice. Always discuss eligibility with your doctor before enrolling in a clinical trial.

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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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