NCT04319848 Safety and Efficacy of Tissue Engineered Endothelial Keratoplasty
| NCT ID | NCT04319848 |
| Status | Recruiting |
| Phase | Phase 1 |
| Sponsor | Singapore Eye Research Institute |
| Condition | Mild to Moderate Corneal Endothelial Decompensation |
| Study Type | INTERVENTIONAL |
| Enrollment | 30 participants |
| Start Date | 2017-12-01 |
| Primary Completion | 2027-12 |
Eligibility & Interventions
Eligibility Fast-Check
Enter your details for a quick preliminary check. This does not replace medical advice.
What to Expect as a Participant
You will actively receive the study intervention — which may be a drug, biologic, device, or procedure.
Phase 1 is the earliest stage of human testing — safety and dosage are the primary focus. Visits are frequent and medical supervision is intensive. You will be among the first people to receive this treatment.
This trial targets 30 participants in total. It began in 2017-12-01 with a primary completion date of 2027-12.
⚠ This information is for research awareness only. Always consult your physician before joining any clinical trial. Participation is voluntary and you may withdraw at any time.
Brief 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 Criteria
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
Contact & Investigator
Jodhbir Mehta
PRINCIPAL INVESTIGATOR
Singapore Eye Research Institute
Frequently Asked Questions
Who can join the NCT04319848 clinical trial?
This trial is open to participants of all sexes, aged 21 Years or older, up to 80 Years, studying Mild to Moderate Corneal Endothelial Decompensation. Full inclusion and exclusion criteria are listed in the Eligibility Criteria section. Always confirm your eligibility with the research team before applying.
What phase is the NCT04319848 trial and what does that mean for participants?
Phase 1 trials are the first stage of human testing. The primary goal is to assess safety and determine appropriate dosage levels. Participants are closely monitored. These trials typically involve a small number of volunteers.
Is NCT04319848 currently recruiting?
Yes, NCT04319848 is actively recruiting participants. Contact the research team at lim.lee.yan@seri.com.sg for enrollment information.
Where is the NCT04319848 trial being conducted?
This trial is being conducted at Singapore, Singapore.
Who is sponsoring the NCT04319848 clinical trial?
NCT04319848 is sponsored by Singapore Eye Research Institute. The principal investigator is Jodhbir Mehta at Singapore Eye Research Institute. The trial plans to enroll 30 participants.