Simple Non-cultured Endothelial Cell Therapy for Corneal Endothelial Dysfunction
For patients and families
In plain language
An automatic summary of structured registry data. It is an orientation aid, not a substitute for the official protocol or a physician assessment.
- What is being studied
- The protocol lists: Cell injection.
- Who it may be relevant to
- Registry conditions: Bullous Keratopathy, Corneal Endothelial Dystrophy. Basic parameters: 18 years — 80 years · All.
- What needs checking
- Age, condition and sex are only basic indicators. Prior treatment, laboratory values and other mandatory requirements appear in the eligibility criteria below.
- Where it takes place
- India
- Next step
- Save the trial, show it to the treating physician, and confirm current recruitment with the study center. Costs, documents and travel →
Unsure about the terms? Read our patient guide →
Official title
Safety and Efficacy of Simple Non-cultured Endothelial Cell Injection(SNEC-I) Therapy for Corneal Endothelial Dysfunction
Overview
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
- Biological Cell injection
Direct endothelial cell injection of non-cultured corneal endothelial cells
Primary outcome measures
- BSCVA [Time frame: 1, 3, 6, 12 months post-operatively]
Secondary outcome measures (5)
- Autokeratorefractometer [Time frame: 1, 3, 6, and 12 months post-operatively]
- Intraocular pressure [Time frame: 1, 3, 6 and 12 months post-operatively]
- Endothelial Cell Density [Time frame: 1, 3, 6 and 12 months post-operatively]
- Graft thickness [Time frame: 1, 3, 6 and 12 months post-operatively]
- Contrast Sensitivity [Time frame: 6, 12 months post-operatively]
Eligibility 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
- Severe forms or late-stage presentation of corneal decompensation with severe corneal stromal scarring and or scarring to the DM, unsuitable for SNEC-I.
- Patients with complex anterior segment complications precluding a successful SNEC-I procedure
- Patients who have other forms of endothelial dystrophy, traumatic corneal decompensation, or post-inflammatory corneal decompensation
- Post-laser iridotomy or glaucoma related corneal decompensation
- Patients not keen to participate in the clinical trial
- Patients who are below 21 years of age or above 80 years of age
- Patients who are pregnant
- Patients who are cognitively impaired
- Patients who are prisoners
- Patients with antibiotics/antimycotics allergies
Criteria are shown verbatim from the registry (in English). Final eligibility is always assessed by the study center.
Healthy volunteers: No
Study design
- Allocation
- N/A
- Model
- Single group
- Masking
- Open label
- Primary purpose
- Treatment
Study locations
India · 1 center
- L V Prasad Eye Institute — Hyderabad
Identifiers
NCT: NCT07711561 · 2024/2127 · CTRI/2026/06/111973