Health Condition 1: H181- Bullous keratopathy
Conditions
Interventions
Intervention1: Direct endothelial cell injection therapy: Non cultured endothelial cells from Donor cornea will be used
Control Intervention1: NA: NA
Sponsors
L V Prasad Eye Institite
Eligibility
Inclusion criteria
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
Exclusion criteria: a)Severe forms or late-stage presentation of corneal decompensation with severe corneal stromal scarring and or scarring to the DM, unsuitable for SNEC-I. b)Patients with complex anterior segment complications precluding a successful SNEC-I procedure c)Patients who have other forms of endothelial dystrophy, traumatic corneal decompensation, or post-inflammatory corneal decompensation d)Post-laser iridotomy or glaucoma related corneal decompensation e)Patients not keen to participate in the clinical trial f)Patients who are below 21 years of age or above 80 years of age g)Patients who are pregnant h)Patients who are cognitively impaired i)Patients who are prisoners j)Patients with antibiotics/antimycotics allergies
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| 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.Timepoint: 1, 3, 6 and 12 months | — |
Secondary
| Measure | Time frame |
|---|---|
| All these examinations are the routine examinations for patients following EK surgery and are non-invasive and non-contact: 1.Keratometric astigmatism and spherical equivalent: will be measured by an autokeratorefractometer (RK-8100; Topcon, Tokyo, Japan) 3.Intraocular pressure: will be measured by a noncontact tonometry (CT-60; Topcon) 4.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 5.Graft thickness: will be measured by ASOCT (Visante OCT, Carl Zeiss Meditec) 6.Contrast sensitivity: will be assessed at 6 and 12 months Timepoint: 1, 3, 6 and 12 months post-operatively | — |
Countries
India
Contacts
Public ContactDrSunita Chaurasia
L V Prasad Eye Institute
Outcome results
None listed