Tissue-engineered endothelial keratoplasty with lab-grown corneal endothelial grafts

Is this trial a fit for you?

A plain-English reading of the study's rules. Only the study team can confirm whether you qualify.

What this trial studies

This Phase 1 interventional trial implants tissue-engineered endothelial keratoplasty (TE-EK) graft material created from cultured human corneal endothelial cells propagated using a regulatory-approved dual media method. Surgeries follow current endothelial keratoplasty (EK) protocols at the Singapore National Eye Centre with standard postoperative care and scheduled follow-up visits. Clinical outcomes include visual acuity, intraocular pressure, keratometric astigmatism, spherical equivalent, endothelial cell density, AS-OCT imaging, contrast sensitivity, and monitoring for complications such as graft dislocation or primary graft failure. The primary focus of this first-in-human study is safety, with preliminary efficacy signals recorded as secondary outcomes.

Why it matters

Who can join: the full rules

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

Where it's running

• Singapore Eye Research Institute
  Singapore, Singapore Recruiting

Study contacts

• Principal investigator: Jodhbir Mehta — Singapore Eye Research Institute
• Study coordinator: Lee Yan Lim
• Email: lim.lee.yan@seri.com.sg
• Phone: +65 6576 7322

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How to take part

1. Review the eligibility criteria above with your treating physician.
2. Check the official listing on ClinicalTrials.gov for the latest contact details and recruitment status.
3. Contact the study coordinator or principal investigator to ask for pre-screening. Pre-screening is free and never obligates you to enroll.