A Phase 1 interventional study of Cell injection in Bullous Keratopathy and Corneal Endothelial Dystrophy, sponsored by Singapore Eye Research Institute. Recruiting at 1 site in India. Open to participants aged 18 Years to 80 Years. Per ClinicalTrials.gov, last updated 2026-07-17.
Sponsored by Singapore Eye Research Institute · Phase 1, Interventional, and Treatment
Assessment of safety and efficacy of cell injection therapy generated using non-cultured human corneal endothelial cells in treating corneal endothelial dysfunction
The specific aim of this clinical trial is to assess the clinical efficacy and safety outcomes of patients receiving cell injection therapy generated from non-cultured human corneal endothelial cells. Clinical assessments include postoperative visual acuity, intraocular pressure, keratometric astigmatism, spherical equivalent, endothelial cell density, anterior segment optical coherence tomography (ASOCT), contrast sensitivity, as well as any postoperative complications such as graft dislocation or primary graft failure.
Singapore Eye Research Institute is the lead sponsor of 27 studies on the registry; 12 are open to participants now.
Counted across the registry records on this site, refreshed daily.
Go through the criteria one by one — yes, no or not sure — and take the list to your doctor or the study team. Kept in this browser only.
Patients who have mild to moderate corneal endothelial decompensation or bullous keratopathy, but with minimal corneal stromal scarring resulting from irreversible post-surgical corneal decompensation, specifically, all forms of pseudophakic or aphakic bullous keratopathy.
Exclusion Criteria:
Direct endothelial cell injection
Biological: Cell injection
Direct endothelial cell injection of non-cultured corneal endothelial cells
BSCVA
Snellen best spectacle-corrected visual acuity (BSCVA). The Snellen BSCVA will be converted to logarithm of the minimum angle of resolution visual acuity for statistical analysis.
Time frame: 1, 3, 6, 12 months post-operatively
Autokeratorefractometer
Keratometric astigmatism and spherical equivalent: will be measured by an autokeratorefractometer (RK-8100; Topcon, Tokyo, Japan)
Time frame: 1, 3, 6, and 12 months post-operatively
Intraocular pressure
Intraocular pressure: will be measured by a noncontact tonometry (CT-60; Topcon)
Time frame: 1, 3, 6 and 12 months post-operatively
Endothelial Cell Density
Endothelial cell density (ECD): will be measured by a noncontact specular microscope (Konan Medical Corp, Hyogo, Japan). The ECD data will be expressed as percentage of cell loss compared with the donor ECD
Time frame: 1, 3, 6 and 12 months post-operatively
Graft thickness
Graft thickness: will be measured by ASOCT (Visante OCT, Carl Zeiss Meditec)
Time frame: 1, 3, 6 and 12 months post-operatively
Contrast Sensitivity
Time frame: 6, 12 months post-operatively
Plan to share: No
No publications or documents are linked to this record.
Started Jun 2026 (actual). Primary completion is estimated for Jul 2028, 25 months after the start.
How these figures are worked out, and which studies are left out of them.
Eligibility is decided by the study team. Share this record with your doctor or contact the team directly.
No contact was published for this record. The registry link below has the sponsor’s details.
Get an email when the registry record changes — status, dates, results — or when someone posts here.
Sign in to followQuestions and observations about this study, from anyone following it. Not medical advice, and not a channel to the study team — their contact details are on the registry record.
Sign in to join the discussion. Reading takes no account; posting does. You choose a display name, and a pseudonym is the default.
Nothing here yet. If you are running this trial, taking part in it, or weighing whether to, this is the place to say so.
Studies of the drug tested here: Cell Types
Corneal Dystrophy, Posterior Polymorphous, 1
Singapore Eye Research Institute