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.
Study Type
INTERVENTIONAL
Allocation
NA
Purpose
TREATMENT
Masking
NONE
Enrollment
20
Direct endothelial cell injection of non-cultured corneal endothelial cells
L V Prasad Eye Institute
Hyderabad, Telangana, India
RECRUITINGBSCVA
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
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