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| ID | Type | Description | Link |
|---|---|---|---|
| CTRI/2026/06/111973 | Registry Identifier | Clinical Trials Registry - India |
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| Name | Class |
|---|---|
| L.V. Prasad Eye Institute | OTHER |
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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.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Cell Injection | Experimental | Direct endothelial cell injection |
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| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Cell injection | Biological | Direct endothelial cell injection of non-cultured corneal endothelial cells |
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| Measure | Description | Time Frame |
|---|---|---|
| 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. | 1, 3, 6, 12 months post-operatively |
| Measure | Description | Time Frame |
|---|---|---|
| Autokeratorefractometer | Keratometric astigmatism and spherical equivalent: will be measured by an autokeratorefractometer (RK-8100; Topcon, Tokyo, Japan) | 1, 3, 6, and 12 months post-operatively |
| Intraocular pressure |
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Inclusion Criteria:
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:
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| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| L V Prasad Eye Institute | Recruiting | Hyderabad | Telangana | 500034 | India |
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| ID | Term |
|---|---|
| C562745 | Corneal Dystrophy, Posterior Polymorphous, 1 |
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| ID | Term |
|---|---|
| D043182 | Carboxylesterase |
| ID | Term |
|---|---|
| D002265 | Carboxylic Ester Hydrolases |
| D004950 | Esterases |
| D006867 | Hydrolases |
| D004798 | Enzymes |
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Intraocular pressure: will be measured by a noncontact tonometry (CT-60; Topcon)
| 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 | 1, 3, 6 and 12 months post-operatively |
| Graft thickness | Graft thickness: will be measured by ASOCT (Visante OCT, Carl Zeiss Meditec) | 1, 3, 6 and 12 months post-operatively |
| Contrast Sensitivity | 6, 12 months post-operatively |
| D045762 |
| Enzymes and Coenzymes |