L V Prasad Eye Institute
Hyderabad, Telangana, 500034, India
Location status: Recruiting
NCT Number: NCT07711561
Assessment of safety and efficacy of cell injection therapy generated using non-cultured human corneal endothelial cells in treating corneal endothelial dysfunction
Interested in participating?
Request Info18 year–80 year
All sexes
Interventional
Phase 1
Hyderabad, Telangana, 500034, India
Location status: Recruiting
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.
Healthy volunteers accepted: No
Only the study team can determine whether someone qualifies for participation.
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
Direct endothelial cell injection of non-cultured corneal endothelial cells
Time frame: 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.
Time frame: 1, 3, 6, and 12 months post-operatively
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: will be measured by a noncontact tonometry (CT-60; Topcon)
Time frame: 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
Time frame: 1, 3, 6 and 12 months post-operatively
Graft thickness: will be measured by ASOCT (Visante OCT, Carl Zeiss Meditec)
Time frame: 6, 12 months post-operatively
Singapore Eye Research Institute
Other
Safety and Efficacy of Simple Non-cultured Endothelial Cell Injection(SNEC-I) Therapy for Corneal Endothelial Dysfunction
OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.
View the official ClinicalTrials.gov record (opens in a new tab)This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.
Published trials that share one or more normalized conditions with this study.
NCT05636579
Bullous Keratopathy, Congenital, Hereditary, and Neonatal Diseases and Abnormalities
Mexico City, Mexico
View Trial DetailsNCT04894110
Bullous Keratopathy, Congenital, Hereditary, and Neonatal Diseases and Abnormalities
Greater Los Angeles, California, United States
View Trial DetailsNCT05436665
Bullous Keratopathy, Congenital, Hereditary, and Neonatal Diseases and Abnormalities
Edegem, Antwerp, Belgium
View Trial DetailsNCT04319848
Bullous Keratopathy, Congenital, Hereditary, and Neonatal Diseases and Abnormalities
Singapore
View Trial Details