Bullous Keratopathy, Corneal Endothelial Dystrophy
Conditions
Keywords
Cell therapy, Corneal endothelial dystophy, corneal endothelial dysfunction, cell injection
Brief summary
Assessment of safety and efficacy of cell injection therapy generated using non-cultured human corneal endothelial cells in treating corneal endothelial dysfunction
Detailed description
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.
Interventions
BIOLOGICALCell injection
Direct endothelial cell injection of non-cultured corneal endothelial cells
Sponsors
Singapore Eye Research Institute
L.V. Prasad Eye Institute
Study design
Allocation
NA
Intervention model
SINGLE_GROUP
Primary purpose
TREATMENT
Masking
NONE
Eligibility
Sex/Gender
ALL
Age
18 Years to 80 Years
Healthy volunteers
No
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
1. Severe forms or late-stage presentation of corneal decompensation with severe corneal stromal scarring and or scarring to the DM, unsuitable for SNEC-I. 2. Patients with complex anterior segment complications precluding a successful SNEC-I procedure 3. Patients who have other forms of endothelial dystrophy, traumatic corneal decompensation, or post-inflammatory corneal decompensation 4. Post-laser iridotomy or glaucoma related corneal decompensation 5. Patients not keen to participate in the clinical trial 6. Patients who are below 21 years of age or above 80 years of age 7. Patients who are pregnant 8. Patients who are cognitively impaired 9. Patients who are prisoners 10. Patients with antibiotics/antimycotics allergies
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| BSCVA | 1, 3, 6, 12 months post-operatively | 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. |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Autokeratorefractometer | 1, 3, 6, and 12 months post-operatively | Keratometric astigmatism and spherical equivalent: will be measured by an autokeratorefractometer (RK-8100; Topcon, Tokyo, Japan) |
| Intraocular pressure | 1, 3, 6 and 12 months post-operatively | Intraocular pressure: will be measured by a noncontact tonometry (CT-60; Topcon) |
| Endothelial Cell Density | 1, 3, 6 and 12 months post-operatively | 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 |
| Graft thickness | 1, 3, 6 and 12 months post-operatively | Graft thickness: will be measured by ASOCT (Visante OCT, Carl Zeiss Meditec) |
| Contrast Sensitivity | 6, 12 months post-operatively | — |
Countries
India
Outcome results
None listed